Peer mentorship to promote effective pain management in adolescents: Study protocol for a randomised controlled trial

Article (PDF Available)inTrials 12(1):132 · May 2011with27 Reads
DOI: 10.1186/1745-6215-12-132 · Source: PubMed
Abstract
Background This protocol is for a study of a new program to improve outcomes in children suffering from chronic pain disorders, such as fibromyalgia, recurrent headache, or recurrent abdominal pain. Although teaching active pain self-management skills through cognitive-behavioral therapy (CBT) or a complementary program such as hypnotherapy or yoga has been shown to improve pain and functioning, children with low expectations of skill-building programs may lack motivation to comply with therapists' recommendations. This study will develop and test a new manualized peer-mentorship program which will provide modeling and reinforcement by peers to other adolescents with chronic pain (the mentored participants). The mentorship program will encourage mentored participants to engage in therapies that promote the learning of pain self-management skills and to support the mentored participants' practice of these skills. The study will examine the feasibility of this intervention for both mentors and mentored participants, and will assess the preliminary effectiveness of this program on mentored participants' pain and functional disability. Methods This protocol will recruit adolescents ages 12-17 with chronic pain and randomly assign them to either peer mentorship or a treatment-as-usual control group. Mentored participants will be matched with peer mentors of similar age (ages 14-18) who have actively participated in various treatment modalities through the UCLA Pediatric Pain Program and have learned to function successfully with a chronic pain disorder. The mentors will present information to mentored participants in a supervised and monitored telephone interaction for 2 months to encourage participation in skill-building programs. The control group will receive usual care but without the mentorship intervention. Mentored and control subjects' pain and functioning will be assessed at 2 months (end of intervention for mentored participants) and at 4 month follow-up to see if improvements persist. Measures of treatment adherence, pain, disability, and anxiety and depression will be assessed throughout study participation. Qualitative interviews for mentors, mentored participants, and control subjects will also be administered. Trial registration ClinicalTrials.gov NCT01118988.
STUDY PROT O C O L Open Access
Peer mentorship to promote effective pain
management in adolescents: study protocol for a
randomised controlled trial
Laura B Allen
*
, Jennie CI Tsao, Loran P Hayes and Lonnie K Zeltzer
Abstract
Background: This protocol is for a study of a new pro gram to improve outcomes in children suffering from
chronic pain disorders, such as fibromyalgia, recurrent headache, or recurrent abdominal pain. Although teaching
active pain self-man agement skills through cognitive-behavioral therapy (CBT) or a complementary program such
as hypnoth erapy or yoga has been shown to improve pain and functioning, children with low expectations of skill-
building programs may lack motivation to comply with therapists recommendations. This study will develop and
test a new manualized peer-mentorship program which will provide modeling and reinforcement by peers to
other adolescents with chronic pain (the mentored pa rticipants). The mentorship program will encourage
mentored participants to engage in therapies that promote the lear ning of pain self-management skills and to
support the mentored participants practice of these skills. The study will examine the feasibility of this intervention
for both mentors and mentored participants, and will assess the preliminary effectiveness of this program on
mentored participants pain and functional disability.
Methods: This protocol will recruit adolescents ages 12-17 with chronic pain and randomly assign them to either
peer mentorship or a treatment-as-usual control group. Mentored participants will be matched with peer mentors
of similar age (ages 14-18) who have actively participated in various treatment modalities through the UCLA
Pediatric Pain Program and have learned to function successfully with a chronic pain disorder. The mentors will
present information to mentored participants in a supervised and monitored telephone interaction for 2 months to
encourage participation in skill-building programs. The control group will receive usual care but without the
mentorship intervention. Mentored and control subjects pain and functioning will be assessed at 2 months (end of
intervention for mentored participants) and at 4 month follow-up to see if improvements persist . Measures of
treatment adherence, pain, disability, and anxiety and depression will be assessed throughout study participation.
Qualitative interviews for mentors, mentored participants, and control subjects will also be administered.
Trial registration: ClinicalTrials.gov NCT01118988.
Background
Chronic intractable non-malignant pain, including such
functional disorders as recurrent abdominal pain (RAP)
and chronic daily headache, is now recognized as a signif-
icant problem in children and adolescents, with potent ial
long-term impact on the childs physical, social, and aca-
demic functioning, as well as on the family as a whole.
Est imates of children experiencing recurrent or continu-
ous pain range from 25% - 45.5%, with the most common
types o f pain reported as headaches, abdominal pain,
limb pain, and back pain [1,2]. Many such children
apparently continue to function effective ly, attending
school and continuing normal activ ities, with medical
intervention only for acute episodes. A smaller, but sig-
nificant, number, however, find themselves unable to
self-manage their pain. They become patients with
chronic pain and disability, falling into a cyclical pattern
of pain, impaired functioning in physical, school, social,
and even family and self-care domains, doctor-seeking
and over-utilization of medications, and psychosocial dis-
tress, including anxiety and depression [3].
* Correspondence: LBAllen@mednet.ucla.edu
Pediatric Pain Program, David Geffen School of Medicine at UCLA, Los
Angeles, CA, USA
Allen et al. Trials 2011, 12:132
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TRIALS
© 2011 Allen et al; licensee BioMed Central Ltd. Thi s is an Open Access article distributed under the terms of the Creative Commons
Attribution License (http://crea tivecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in
any med ium, provided the original work is properly cited.
Functional impairment, particularly in academic work
and social participation, is likely to have long-term effects
on the individual s quality of life, even aside from the
possibility that pain and physical limitations may persist
into adulthood. Several well-designed studies using quan-
titative measures have provided evidence that impaired
functioning in children with chronic pain is strongly
associated with psychosocial distress [4-6] and with lower
quality of life [4,7-10]. In particular, children with unex-
plained chronic pain - pain not associated with an identi-
fied organic diagnosis - often report significant
dysfunction i n normal activities, such as schoolwork,
sleep, family activities, and athletic activities [10].
Although impaired functioning is a major factor in lower
quality of life for children with chronic pain, we still
know relativel y l ittle about the prevalence an d severity o f
functional impairment, why some children experience
more limitations than others, and which treatment inter-
ventions are the most effective in improving function
[11].
Current Therapeutic Interventions
When chronic pain cannot be fully alleviated, the optimal
goal is for the adolescent is to learn effective ways to con-
tinue functioning an d to self- manage pain. Several thera-
peutic programs have been developed, based on theories
of health behavior change, to assist the patient in this
process [12]. The newer therapeutic programs, the most
well-known and widely practiced of which is cognitive-
behavioral therapy (CBT), seek to mediate behavioral
change through cognitive relearning. CBT employs a
number of methods - including psychoeducation about
the nature of pain responses, identification and modifica-
tion of maladaptive cognitions, and encouraging beha-
vioral changes to reduce or eliminate avoidance of
activities [13,14]. Numerous controlled trials have shown
CBT to be effective for a variety of types of pain, includ-
ing in the child and adolescent populations [14-19].
In additio n to psychot herapy, other t ypes of co mple-
mentary and alternative medicine (CAM) practices have
shown varying levels of efficacy for chronic pain. These
include interventions such as Iyengar yoga for rheumatoid
arthritis [20], and acupuncture for low back pain [21]. In a
2005 review of studies examining CAM treatments for
chronic pain conditions in children, Tsao and Zeltzer [22]
found hypnosis and guided imagery to be efficacious for
recurrent pediatric headaches, a nd found acupuncture,
biofeedback, creative arts, herbal therapy, homeopathy,
and massage therapy to be either promising or possibly
efficacious for a wide variety of pediatric chronic pain
conditions. Furthermore, the authors found multiple mod-
alities packaged together to be more efficacious.
A well-designed intervention , however, is not enough.
Patient motivation is at least one of the critical factors
in successful outcomes of this therapeutic model [14].
Jensen and colleagues have r ecently proposed a cogent
general model that integrates the varied the oretical
approaches to describe a dynamic process that pivots on
this concept of motivation, or readiness to change. An
individuals readiness to change , they a rgue, is essential
to his/her ability to learn successful pain self-manage-
ment through new behaviors. They suggest some clinical
approaches for enhancin g readiness and promoting
change, including encouragement to practice self-man-
agement; allowing the patient to observe other pain
patients practice self-management; support of positive
beliefs and non-judgmental non-support of negative
beliefs; and de velopment of a plan to address real or
perceived barriers; and they call for research into inter-
ventions along these lines to enhance motivation [12].
Another formulation recently proposed by Sharp stres-
ses the patients cognitive activity in appraising and evalu-
ating his or her pain, and its ongoing and interactive
effects on mood, behavior, and somatic focus [23]. The
patients initial response to the pain is a function of cul-
tural beliefs, learning history, and current contingencies,
he argues, but then is continually reinterpreted with
ongoing events. In particular, anxiety about recurrent pain
and avoidance of activity that might cause pain will help
to perpetuate th e patient s hypervigilance for signs of
recurring pain ( as described by Eccleston and Crombez
[24]) and his/her perceived inability to manage the pain.
Moreover, Sharp contends that this attitude of learned
helplessness may be perpetuated by physicians who have
failed to offer helpful treatment or even to confirm the
physical reality of the patients suffering. That is, patients
could start to believe that nothing has work ed so far so
why would any future treatment help? [23] A patient who
has reached this point is likely to have a negative assess-
ment both of the benefits of pain self-management and of
his/her own ability or self-efficacy to learn these skills, and
will therefore show a lack of readiness to change.
While current interventionssuchasthosementioned
above are known t o be effective, adherence to recom-
mended treatments in children with chronic health con-
ditions is typically low [25]. Simons et al. [19] report only
a 46.7% rate of full adherence (defined as completing
the full recommended course of treatment or currently
receiving the treatment) to a referral of cognitive-beha-
vioral therapy for children with chronic pain, lower than
adherence rates for other treatment modalities (i.e., med-
ical and physical therapy referrals). The authors also
asse ssed barri ers to treatment among non-adherents and
found that negative attitudes and beliefs regarding the
recommended intervention to be the most frequently
cited reason for not completing the recommended treat-
ment. This find ing suggests that determining methods to
improve adherence to recomme nded treatments is a
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necessary step to improving pain and functioning in this
population.
Strategies for Adolescents: Peer Mentoring
Innovative strategies to promote pain self-management in
adolescents with chronic pain may be especially needed, as
this age group has shown great variance in motivation and
adherence in studies of CBT-based therapies for other
chronic health conditions. In fact, children of all ages
demonstrate low rates of adherence to recommended
treatments fo r chr onic health c onditions, ranging from
11% to 50% [25]. However, some researchers have
reported that motivation and adherence can be enhanced
if young people have the opportunity to interact with
peers who model and reinforce adherent behaviors, and
Varni et al. have argued convincingly for the power of
peer relationships and social supports in mediating adjust-
ment to chronic malfunctions [25,26].
Peer mentors most often work in programs designed
to en courage des ired social and preventive health beha-
viors, such as nutrition and tobacco abstinence [27],
non-violence [28], sexual a bstinence [29], or HIV pre-
vention [30] in physically healthy children. In a low-
income area of Chicago, for example, 19 self-selected
adolescents aged 14-21 designed and presented vio-
lence-prevention lessons to 50 younger children (7-13)
over an 18-month period. Post-intervention, the men-
tored children showed lower acceptance of violence
after the intervention than a control group of 75 chil-
dren [28]; 11 of the adolescents continued with the pro-
gram and 3 entered college or employment. Peer
mentorship has only bee n explored in a f ew instances
within medical treatment programs. In a youth-run pro-
gram in San Francisco, peer-mentor-advocates have
effectively empowered young people infected with HIV
(ages 26 and younger) to access needed services and to
learn coping skil ls for living with the disease [31]. Peer
support has also been the subject of several studies of
adolescents with diabetes, where researchers have found
that the support of friend-pe ers is a critical resource for
diabetic teens, providing important social and emotional
support, and that structured peer-group interactions
may improve adherence to glucose self-monitoring and
control [32-34]. Greco and colleagues reported a suc-
cessful education and support group intervention with
21 diabetic adolescents (ages 10-18) and their best
friends (4 s essions); both the patients and their friends
demonstrated higher levels of knowledge about the dis-
ease and its care, and the patients reported a higher
ratio of peer-t o-family support [33]. Clemente has used
ethnographic methods to document the informal peer-
mentoring provided to children newly admitted to can-
cer treatment wards by p eers who had been through
several treatment cycles [35]. We contend that trained
peer mentors, who have successfully learned pain self-
management skills, are an effective and feasible choice
to pr omote pain self-management in the adolescent
chronic pain population beca use this interventi on has
the pot ential to relieve the sense of isolation, difference,
and helplessness reported by the adolescents.
In this exploratory pilot study, we will finalize devel-
opment of an innovative, manualized peer-mentorship
program designed to provide modeling and reinforce-
ment by peers to other adolescents with chronic pain
(the mentored participants). The goal of the mentor-
ship will be to encourage the mentored participants to
engage in therapies that promote the learning of pain
self-management skills and to support the mentored
participants practice of these learned skills during a
two-month interventi on perio d. The study will examine
the feasibility of this intervention for both m entors and
mento red participants, and, through a randomized, con-
trolled design, will assess the preliminary effectiveness of
this pro gram for both short and longer term effects on
mentored participants pain and functional disability.
Aims
1. To test the feasibility and acceptability of a peer-
mentorship intervention in supporting an d encoura-
ging adolescents with chronic pain and pain-related
functional disability (the mentored participants )to
participate and persist in an active s kills-building
therapy that teaches pain self-management skills.
2. To test the feasibility of training adolescents who
have coped suc cessfully with chronic pai n (the men-
tors ) to offer support and reinforcement to their
peers in a structured peer-mentorship intervention,
based on a manualized protoco l developed within a
social learning model grounded in CBT principles.
3. To determine if the m entored participants with
chronic pain sho w improved adherence to recom-
mended skills-building therapies, compared to a
usual care control group of adolescents with chronic
pain immediately a fter the two-month peer-mentor-
ship intervention and at two-month follow-up (four
months from baseline).
4. To determine if the mentored participant s with
chronic pain show improvements in pain levels and
pain-related disability, compared to a usual care control
group of adolescents with chronic pain immediately
after the two-month peer-mentorship intervention and
at two-month follow-up.
Hypotheses
We propose to test our hypotheses through a trial of a
peer mentorship intervention, using trained adolescents
who have successfully learned pain management skills as
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mentors. The mentors will help to relieve the adoles-
cents sense of isolation and d ifference by relating their
similar experiences, provide models of succ essful sk ill
learning and reinforce the mentored participants parti-
cipation in skill learning activities. We propose the
following hypotheses:
1. Adolescents receiving the peer mentorship inter-
vention will report better adherence to recom-
mended therapies, as compared to adolescents who
do not receive the intervention.
2. Adolescents with better adherence to recom-
mended therapies will show more improvement in
pain and pa in-related disability 2 and 4 months after
baseline than those with poor adherence.
3. Adolescents receiving the peer mentorship inter-
vention will report decre ased symptoms of anxiety
and depression and improved pain coping skills, a s
compared to adolescents who do not receive the
intervention.
Methods/Design
Sample
Mentored and Control Subjects
All potential participants must be patients of the UCLA
Pediatric Pain Program. During the first visit (prior to
being offered study participation), all clinic patients are
given a thorough medical e valuation a nd are recom-
mended specific therapies to help w ith various skills to
manage their pain. Any English-speaking patient
between the ages of 12 and 17 diagnose d with a chronic
pain disorder at the UCLA Pediatric Pain Prog ram, or
referred with this diagnosis, is eligible to be a subject for
the study. Participants must have access to a computer
connected to the internet, as well as a telephone in
order to p articipate in the mentoring and complete
measures administered online. Other than age, the only
exclusions are out-of -area pa tients seen for consultation
only before referral back to local provider s or patients
with another physical or psychological condition that, in
the judgment of the principal investigator (PI), would
make it difficult to participate.
Mentors
Any English-speaking patient between the ages of 14
and 18 years who has been treated for a chronic pain
disorder at the UCLA Pediatric Pain Clinic and has
been actively inv olved in recommended therapies will be
eligible to serve as a mentor. Participants must have
access to a computer connected to the internet, as well
as a telephone. The PI (LKZ) will identify suitable men-
tors based on her assessment of the adolescents matur-
ity, emotional stability and verbal communication skills.
Mentors will be compensated $12/session.
Randomization
Participants recruited for the mentored or control por-
tion of the study will be randomized using a block ran-
domization procedure to assure equal sample sizes in
the mentoring and control groups. Using this method
allowsthegroupstohavesimilar n umbers of partici-
pants in each gro up at all times. Using a block size of 4,
participants are assigned to the appropriate treatment
conditionastheyenrollinthestudyuntiltheblockis
completed. Then the following 4 participants are
assigned based on the next block [36].
Procedures
Mentor Training
For overall sche matic of the procedures for mentor
training and administration of the intervention see
Figure 2. Mento rs will receive six hours of traini ng with
trained doctoral-level research study personnel in the
UCLA Pediatric Pain Program prior to working with
mentored participants.
Training manual T he training material will include
background on chronic pain disorders and rationales for
pain self-management; specific goals of the program and
the mentor s role; how to present information about
pain and pain-related behaviors; strategies drawn from
CBT to reinforce positive thinking and to challenge
negative statements; guideline s for building the mentor-
ing relationship, dealing with difficult issues (e.g.,
depression, suicidality, or othe r potential emergen cies
such as disclosure of abuse), and ending the interac-
tions. Mentors will be given a written manual presenting
all the material in detail for their ongoing reference. The
mentors specific objectives will be to provide informa-
tion about pain, pain-related behaviors, thoughts, and
feelings, and the nature of recommend ed treatments, as
well as to alleviate the subjects sense of isolation by giv-
ing him or her the opportunity to discuss his or her
pain condition with someone who has shared the
experie nce; to enhance and reinforce the subjectssense
of self-efficacy to manage the pain condition; and to
encourage the mentored participant to participate
actively in the recommended pain self-management
skills building therapy. Mentors will be trained in con-
versational strategies to help them meet the objectives
without being overly directive (see details below).
Peer Mentor Training A postdoctoral psychologist
(LBA) together with other research staff trainers will begin
conducting training when at least six (6) peer mentors
have been identified and recruited. Training will consist of
one six-hour session including all mentors, which will
include the following: 1) Review of slide presentation and
rationale for learning pain self-management, as well as the
contribution of biological, psychological, and social factors
to the pain experience; 2) demonstration and practice o f
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some basic skills to use in working with the mentored par-
ticipants; 3) review of the manual; outline of the format
and required elements for each call; 4) participation in
role-playing exercises in pairs to learn ways of presenting
didactic information, su pporting positive stateme nts, and
responding to questions posed by the mentored p artici-
pant; 5) participation in question development and topic-
starter exercises; 6) participation in troubleshooting exer-
cises to suggest ways of addressing particular problems; 7)
review of call formats, reporting requirements and detailed
discussion of emergency situation procedures.
Prior to working with actual study patients, the best
surrogates for the mentors to p ractice their new skills
with are their fellow mentors, who will all be adoles-
cents with resolved or ongoing recurre nt pain probl ems,
whose recent experiences have been similar to those of
the mentored participants. Each mentor will participate
in several different role-playing exercises during training,
in which the mentors will break into pai rs and impro-
vise conversations t hat will occur between mentor and
mentored participant. For example, they might be told:
One of you will be the mentored participant who has
been to a couple of therapy sessions, but is feeling dis-
couraged, like therapy isnt working and probably noth-
ing is going to help. Talk to your partner and choose a
specific therapy. M ake up a conversation between the
two of you, in which the mentored participant wants to
give up on therapy and the mentor responds to t hose
feelings. Rem ember what you have learned about cogni-
tive-behavioral principles in thinking about what the
mentor should say. These mock conversations will be
observed and critiqued by trainers. Each mentor will be
assigned to no more than three mentored participants at
any one time; some mentors will only work with one
mentored participant during some cycles, to ensure they
can take on a men tored participant if one of the group
becomes ill or has another emergency. (Additional men-
tors may be trained during the i ntervention period if
needed due to attrition or higher than anticipated sub-
ject enrollment.) During the period of active mentor-
ships (about 18 months), mentors will meet monthly
with the research team to revi ew guidelines, provide
feedback, and discuss problem s that may arise. Ment ors
will participate in the ongoing iterative process o f
reviewing and refining the protocol after each cycle.]
Emergency Support Particular attention will be paid to
the rare emergency situations that may arise in the
course of mentor-mentored participant c onversations,
such as disclosure of domestic abuse, suicidal or self-
harm intent. Procedures will be discussed at length in
the training session. The mentor will be given detailed
instructions about how to behave in these specific situa-
tions. In addition, parents of peer mento rs will agree to
be reachable at all times either in person or by phone in
case of emergency. Following any such occurrence, the
mentor will be given immediat e counseling by the PI or
a monitoring research team m ember, and will be
referred for extended counseling if s/he suffers resulting
distress. I n addition, all calls will be monitored directly
by a member of the research team trained in emergency
procedures (i.e. for abuse, suicidality disclosures, etc.)
and recorded using digital audio recorders.
Mentored/Control Subject Assessment
For an overall sc hematic of the asses sment schedule for
mentored participants and controls, please see Figure 1.
The baseline and 2-month follow up assessments will
consist of a semi-structured interview and self-report
questionnaires. The final assessment at four months
from baseline consists only of a self-report questionnaire
packet. For the mentored participants, the study will
consist of baseline assessment, two months of activ e
intervention, immediate follow-up assessment at the end
of interven tion, and then a final assessment at four
months from base line. For the co ntrols, the stu dy will
consist of the baseline assessment, two months of usual
care, immediate assessment, and then follow-up assess-
ment at four months.
Mentored participants and control subjects will be
called once per week during the intervention/usual per-
iod (first 8 weeks of the study) by trained research st udy
personnel to assess use of recommended therapies, med-
ications, and additional non-physician recommended
therapies. During these weekly assessments, research
staff will also assess for the presence of any suicidal
ideation/intent. In addition to monitoring suicidality,
several other assessment measures focused on pain, dis-
ability, and negative affect will be completed weekly by
mentored participant and control subjects online using
a web-based program from a computer in their homes.
Intervention
Each mentored participant will be assigned to a peer
mentor. Each mentor will work with no mor e than three
subjects at one time; once all mentors have been assigned
one to three subjects, recruitment will stop until the
intervention cycle concludes. Cycles may be staggered
depending on recruitment and mentor availability.
Each cycle wil l cons ist of 10 sessions of 30- 60 minute
phone calls conducted over a period of eight weeks. The
mentor and mentored participant(s) will have two ses-
sions per wee k for the first t wo weeks, and one session
per week for the remaini ng six weeks. Current literature
supports the use of an expanding-interva l schedule of
interventions (compared to a massed (single sessio n) or
uniform-interval schedule) with evidence that the
expanding schedule may help to attenuate long-term
recurrence of negative emoti ons [37]. Phone calls will
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take place on a secured, monitored conference ca ll line
so that no participants will exchange personal contact
information. The time of all phone meetings will be
scheduled by the research staff, based on availability of
mentor and mentored participant(s) and will remain at
a fixed time each week. Mentoring sessions will occur
only during the scheduled times and mentored partici-
pant-mentor contact outside of the mentoring sessions
will be specifically prohibited. During each session, par-
ticipants will also be viewing a slide presentation at the
time of the conference call, so that didac tic information
can be prese nted. This pr esentation has been developed
by doctoral-level resea rch staff. As previously men-
tioned, to ensure safety of all participants, a member of
the research team will be monitoring all telephone calls.
This individual will facilitate the discussion, only if
necessary, as w ell as intervene in any potential safety
concerns (e.g., discussion of suicidal idea tion) or inap-
propriate behavior (e.g., bullying).
In an effort to in crease adherence, men tored partici-
pants will be informed that if they miss two consecutive
mentoring sessions, or miss three sessions total over the
course of the intervention for non-emergency reasons,
they will be removed from the study. Additionally, peer
Baseline/Intake Visit 1 Mentored Partcipants & Controls (in person)
1. Informed Consent
2. Baseline self-report measures
3. Initial Qualitative Interview
Intervention Period: Mentored
Participants
(8 weeks)
1. 2 calls/week for first 2 weeks; 1
call/week for final 6 weeks
2. Weekly measures
Intervention Period: Controls
(8 weeks)
1. Weekly measures
2 month follow-up: Controls
1. Self-report measures
2. Post-Intervention Qualitative
Interview
4 month follow-up: Mentored Participants and Controls
1. Self-report measures
2 month follow-up: Mentored
Participants
1. Self-report measures
2. Post-Intervention Qualitative
Interview
Recruitment/Screening for Controls/Mentored Participants:
1. Inquire about interest
2. Screen for eligibility
Figure 1 Procedural flow chart for mentored participants and controls.
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mentors who miss two mentoring sessions (for non-
emergency reasons) will be removed from further parti-
cipation as a mentor. Mentored participants will then be
reassigned to a new mentor for the remaining sessions.
Ethics
All participants (mentors, mentored participants and
control subjects) provide voluntary written informed
assent or consent with full knowledge of study participa-
tion requirements and potential risks. When required
for participants who are legal minors, voluntary written
informed parental consent is also requested. All partici-
pants are informed that any decision about participation
will have no effect on their relationship with UCLA or
their medical care at UCLA. This study was approved
by the UCLA Institutional Review Board.
Training: Mentors
1. Training manual and slides given to
mentors
Intervention Period: Mentors
(8 weeks)
Weeks 1-2: 2 sessions/week
Weeks 3-8: 1 session/week
Re-assignment to New
Mentored Partici
p
ant
(
s
)
Exit Interview
1. Self-report measures
2. Post-Intervention Qualitative Interview
PI Identification of
potential Mentor
PI contacts potential mentor regarding
interest in study; obtains permission for
research team to contact
Staff member contacts potential mentor
via telephone
1. Reads recruitment script
2. Schedules intake interview
Baseline Visit
1. Obtain informed assent/consent
2. Self-report measures
3. Initial qualitative interview
Staff informs mentor of pairing; answers
questions and refreshes mentor on
procedures
Figure 2 Procedural flow chart for mentors.
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Measures
Primary Outcomes
1. Adherence to recommended therapies, use of
additional therapies, and medication use will be eval-
uated using the
Treatment Services Tracking Form -
a measure designed specifically for use in this study
to assess number of visits and missed appointments
with team clinicians each week. This form is admi-
nist ered verbal ly by research staff. Treatment adher-
ence reported by participants is then corroborated
with reports from program clinicians.
2. Pain: Demographics questionnaire and pain level
as indicate d on a body diagram and severa l
Numeri-
cal Rating Scales (NRS; 0-10 scale) [38] to represent a
continuum from no pai n at all to the worst pain pos-
sible. The NRS has been established and widely used
as a valid and reliable measure of pain intensity.
3. Functioning:
a. Self-perceptions of difficulty in physical and
psychosocial functioning due to physical health
as measured on the
Functional Disability Inven-
tory (FDI) [39], a well-validated 14-item self-
report questionnaire with a five point scale that
asks children the level of difficulty they have
with typical daily activities.
b. Self-perceptions of health and functioning as
measur ed on the
Childrens Health Questionnaire
(CHQ), a quality of life i nstrument designed for
use with children age 5 and above. The CHQ
measures 14 unique physical and psychosocial
health concepts (e.g., p hysical functioning, limita-
tions in school, sel f-esteem, ment al health, family
functioning) that can be analyzed and reported
separately or combined to derive an overall physi-
cal and overall psychosocial score. There are 87
items [40].
Secondary Outcomes
4. Anxiety and Depressive Symptoms:
a. The
Child Anxiety Sensitivity Index (CASI), an
18-item scale for measuring anxiety sensitivity.
Children rate each item (e.g., It scares me when
I feel like I am going to throw up) on a scale
ranging from none to a lot [41].
b. Symptoms corresponding to selected DSM-IV
anxiety disorders and depression, as assessed by
the 47-item, 4-point,
Revised Child Anxiety and
Depression Scale (RCADS) [42,43].
c. Suicidal ideation will be assessed using a ques-
tion from the
Beck Depression Inventory - 2
nd
edition (BDI-II) to assess suicidality [44].
For a complete list of measures an d time points at
which they are administered for each subject group,
please see Tables 1 and 2.
Statistical analysis
Sample size
Sample Size Determination and Power Analysis The
proposed sample size was calculated with two objectives
in mind: 1) to remain realistic in terms of recruitment
based on our anticipated p atient flow and the proposed
time frame; and 2) to ensure the power to detect signifi-
cant group differences in the primary outcome measures.
Based on our average patient intake of 8-12 new p atients
a month and the parameter s of our exis ting population,
we estimate that we will be ab le to recruit 3-4 per month
in the target ag e group (12-17) to participate in this pilot
study, or a minimum N of 50. About 70% will be girls,
30%boys.Themajoritywillbenon-Hispanicwhite,but
about 33% will be from other ethnic groups or of mixed-
race. T he second objective in calculating the proposed
sample size is to ensure ad equate power (.80) to detect
variabl e relationships (two-tailed, p < .05) when conduct-
ing the primary analyses. Since there have been no com-
parable studies of peer mentorship interventions and
there are no data available to calculate effect sizes for
adherence to skill-based therapies in a pediatric chronic
pain population, we have chosen t he conservative strat-
egy of extrapolating from other studies of pediatric pain
that have used the Functional Disability Inventory (FDI)
[39] as an outcome measure i n evaluating a CBT-based
intervention, in making our power calculations. One
study [45] included 30 adolescents with fibromyalgia ran-
domized to either 8 weeks of coping skills training or
control (self-monitoring) and then crossed-over to the
alternate condition. For the FDI, the authors reported
overall effect sizes of 1.29 for patients (n = 14) who
received the self-monitoring first and then the coping
skills training and 0.52 for patients (n = 13) who received
the coping skills training followed by self-monitoring. A
second study examined an 8 week CBT trial in 44 adoles-
cents with fibromyalgia [46]. These authors found a sig-
nificant reduction in the FDI following treatment
compared to waitlist control, with an effect size of 0.75.
Using the smallest effect size reported in these two stu-
dies (i.e., .52), which corresponds to a medium sized
effect according to the conventions propose d by Cohen
[47], with power of .80 to detect a significant difference
in FDI scor es using tw o-tailed test s and with alpha set at
.05, it is estimated that we will be able to detect this effect
size with 29 subjects per group.
We expect to recruit 4 - 6 ment ored participants for
each two-month cycle during the active interve ntion
period of 16 months, yielding approximately 32 - 48
mentored participants, with a corresponding number of
controls, and seven mento rs, giv ing a total study enroll-
ment number of 70 - 100.
Preliminary Analyses Once the data set has been
cleaned and examined for skewness and missing data,
Allen et al. Trials 2011, 12:132
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Page 8 of 12
exploratory data analyses will be conducted using univari-
ate methods to describe the variables of interest and
bivariate techniques to characterize their interrelationships
within our sample. Continuous variables will be summar-
ized over time in each group using means and medians
and we will also report their range, interquartile range and
standard deviations. Cro ss tabulated frequencies will be
given for all discrete variab les by group and time. Both
parametric and non parametric correlations will be
reported. Results f rom these descriptive a nalyses will be
used to help guide the primary analyses by providing
information about potential problem measures (e.g., heav-
ily skewed distributions) or problematic variable relation-
ships (e.g., highly correlated predictors) and will help
determine if transformations of some outcomes (such as
percent adherence) are possible in order to use parametric
methods. Only after a full de scriptive investigation of th e
dataset has been achieved and potential problem variables
identified will primary analyses commence. Potential cov-
ariates will be examined prior to final statistical modeling
to determine whether there are pre-existing differences
between the groups. These exploratory analyses will test
for differences in demographic and clinical parameters as
well as psychological aspects that have been found to cor-
relate with functioning in our prior work. We will also
look at mentored participant outcomes within and across
mentors to attempt to determine if there are any discern-
able patterns of improvement or decline in functioning as
a function of clustering of outcomes within mentors or
outcomes as a function of each mentors experience with
the protocol. This will help account for therapist effects as
well as potential learning and/or fatigue effects. Any vari-
ables found to vary significantly by group will be included
as covariates in primary and secondary analyses. This will
also serve to verify that the randomization was successful.
Primary Analyses The primary outcomes are adherence
(percent of sessions attended, percent of home exercises
completed). The primary analysis method is repeated mea-
sure analysis of variance (ANOVA) between the two
groups or the non parametric equivalent (Friedman proce-
dure). We will subtract baseline value from the 2- and 4-
month assessment values and use residualized change
scores from baseline as the outcome. We will use the
Tukey-Fisher criteria for post hoc mean/median compari-
sons un der the ANOVA or Friedman model. The same
methods will be used for the analyses on NRS and FDI
scores.
Secondary Analyses Repeated measure analysis of var-
iance(ANOVA)betweenthetwogroupsorthenon
param etric equivalent (Friedman procedure) will also be
Table 1 Timetable for study participation for mentored and control subjects
TIME PERIOD
STUDY PARTICIPATION FOR ADOLESCENT MENTORED AND
CONTROL SUBJECTS
Baseline Week 1-2 Week 3-8 2-month
follow-up
Weeks 9-
16
4-month
follow-up
Measures
Demographics, NRS & body diagram X X X X X
FDI X X X X X
CASI X X X
RCADS X X X
BDI-II suicidality X X X X X
Treatment tracking X X X X X
Interview X X
Estimated Time Required for Study Participation 76 MINS 140-260
MINS
240-420
MINS
86 MINS 56 MINS
Table 2 Timetable for study participation for peer mentors
TIME PERIOD
STUDY PARTICIPATION FOR ADOLESCENT PEER
MENTORS
Months 1-2 Months 3-4 (first
cycle)
Month 5
(break)
Months 6-18 (cycles
2-5)
Month 19
Training Sessions X
Mentorship Phone Talks and Debriefings X X
Questionnaire Packet X X
Assessment and Review Meetings X X
Interview X X
Estimated Time Required for Study Participation 7.2-7.8
HOURS
9 HOURS 36 HOURS 70-100
MINS
Allen et al. Trials 2011, 12:132
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used to evaluate differences in anxiety and depressive
symptoms (RCADS, CASI) and additional measures. We
will also look at the relation between session attendance
(percent sessions attended) and home exercise c omple-
tion (percent exercises completed) versus FDI change
from baseline. The relation will be quantified by the
Pearson and Spearman correlations. If appropriate, we
will also use regression methods and report intercepts
and slopes.
Attrition We will compare att rition rat es between the
two treatment groups and compare demographics and
baseline values of FDI and other measures of dropouts
to non-d ropouts. If dropouts are random, then the
results are u nbiased. If dropouts are not at random, we
will comment on the direction and magnitude of poten-
tial biases.
Interview Analysis The major goal of the interview ana-
lysis is to elicit t he mentor s and mentored parti cipants
perceptions of the intervention and specific ways in
which they found it helpful (or not helpful). Approxi-
mately 60 minutes will be recorded with each mentor
and selected subject, for a total of 18 interview hours.
The interviewer will use a semi-structured script sug-
gests topic areas and questions, but allows adolescents
to develop each topic in their own words. All interviews
will be transcribed and coded using N*6 software and
applying the principles of grounded theory [47,48].
The coders will code each interview for the number
and strength of the each of the following types o f state-
ments: 1) statements of functioning limitations or of
functioning abilities; 2) statements of self-efficacy to
achieve goals or of lack of self-efficacy; 3) statements that
mentorship was helpful or that it gave little help; 4) state-
ments that learning a pain self-management skill was
helpful or of little help. The strength of a statem ent will
be indicated by the pr esence of modifiers a nd wi ll be
valued using a table of standard statements. Examples of
statements in order of increasing strength: Mom says I
should be able to walk a mile now,”“IthinkIcanwalka
mile now.”“I know I could walk a mile now,”“I walked a
mile yesterday,”“I often wal k a mile now. Values of
statements regarding functioning and self-efficacy wi ll be
compared with changes on quantitative measures for
each child to see if the different types of data corroborate
each other; and also compared with the values of the
childs statements regarding helpfulness of the interven-
tions. State ments regarding the helpfulness of the peer
mentorship intervention and skills building therapies will
be evaluated for strength an d used in the evaluation of
the program.
Additional context-based codes may be assigned, using
the constant comparison method [49], to identify state-
ments regarding treatment expectations and beliefs, pain
expectations and beliefs, fears and an xieties. Coders will
carry out this second-level coding to identify specific
factors promoting changes in the child s functionality
from intake through t he mentorship intervention. All
statements then will be analyzed to determine if the
childrens accounts support the Jensen model [12] of
behavior change described above.
Discussion
This is an exploratory pilot study in which good evidence
of outcome intervention will d epend on the success of a
mentor training program which is still in development.
We have tried to plan all aspects of recruitment and train-
ing carefully, but mentor retention and mentor adherence
to a structured intervention protocol may vary with factors
we have not considered. We will be evaluating carefully
the scheduling, format, and content of communications, as
well as the attrition rate for the control group at both
assessment timepoints. W e considered using electronic
communication because of its greater flexibility, but phone
communication was selected because it will promote social
interaction for those patients who may have stopped
attending school and other activities outside the home.
Peer group therapy is another alternative to introduce
peer modeling and reinforcement into a treatment pro-
gram to improve functioning; but our experience suggests
that group meetings often prove impractical for adoles-
cent s and families with busy daily s chedules. Sampl e size
has been estima ted based on other studies of pediatric
pain that have evaluated CBT-ba sed interventio ns and
reported a lar ge e ffect size. We ma y not ha ve the same
effect size and may have underpowered this pilot study.
Finally, some patients participation in recommended
therapies may be limited by factors, such as insurance
authorizations, over which we have no control.
This exploratory pilot study will enable us to refine
the features of the peer-mentorship model - mentor
training, structure and content of the manual and proto-
col,lengthandformatofinteractions-andtotestour
hypotheses that mentors and mentored participan ts will
find this intervention acceptable and that mentored par-
ticipants will demonstrate improved functioning in com-
parison to a usual care control group by follow-up.
These findings will be disseminated in papers submitted
to peer-reviewed journals. We then plan to test the
refined model in a controlled R01 trial wit h a larger
sample and longer-term subjec t follow-u p, with a med-
iator/moderator model.
List of Abbreviations Used
ANOVA: Analysis of variance; BDI-II: Beck Depression Inventory: 2nd edition;
CASI: Child Anxiety Sensitivity Index; CBT: Cognitive-behavioral therapy; CAM:
Complementary and alternative medicine; FDI: Functional Disability
Inventory; NRS: Numerical Rating Scales; PI: Principal investigator; RAP:
Recurrent abdominal pain; RCADS: Revised Child Anxiety and Depression
Scale.
Allen et al. Trials 2011, 12:132
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Page 10 of 12
Acknowledgements
This study was supported by an award from the National Institute of Child
Health and Human Development (R21HD057421; PI: L. Zeltzer) and an award
from the National Institute of Mental Health (F32MH084424-03; PI: L. Allen).
Authors contributions
JCIT and LKZ participated in the conception of the trial and in plans for the
data analysis, with additional input from LBA. LBA, JCIT, LPH and LKZ drafted
the manuscript. All authors read and approved the final manuscript.
Competing interests
The authors declare that they have no competing interests.
Received: 28 January 2011 Accepted: 22 May 2011
Published: 22 May 2011
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doi:10.1186/1745-6215-12-132
Cite this article as: Allen et al.: Peer mentorship to promote effective
pain management in adolescents: study protocol for a randomised
controlled trial. Trials 2011 12:132.
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  • [Show abstract] [Hide abstract] ABSTRACT: We employ the term postdeployment syndrome (PDS) to characterize the combinations of physical, psychological, and social difficulties frequently encountered by Veterans returning from combat. To conduct a scoping review to identify and describe one-to-one peer mentorship (PM) interventions, identify elements associated with positive outcome and of relevance to Veterans with PDS, and summarize current practice in a way that informs the development of such interventions for this population. Scoping review methodology was used to identify and summarize key practices and concepts in the one-to-one PM literature between 1980 and 2012. Of 196 articles initially identified, 33 were retained for further examination. Eighteen met full-study criteria and were retained in the analyses. Three reviewers reached consensus on articles to include, and 2 coders independently extracted information from each article. A range of populations was targeted in the interventions. Most identified the provision of support as the primary goal, although some also included other educational and behavioral goals. Most employed selection and training strategies for their mentors and offered ongoing supervision and consultation. Most studies indicated that participants found PM to be beneficial. This review supports the application in this population and proposes next steps for the development and systematic evaluation of PM interventions.
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  • [Show abstract] [Hide abstract] ABSTRACT: All relevant databases (i.e., Pubmed, PsycINFO) were searched for studies published in 2011-2013 focusing on the association of behavioral, cognitive-emotional, and psychosocial factors with recurrent headache in children and adolescents. Only 3 studies were found dealing with psychological intervention for headache; only 2 of them presented empirical data but were not conducted as a RCT. Eleven studies (clinical and population) were concerned with the association of psychosocial factors, dysfunctional psychological traits, and symptoms and headache or examined certain pain features (triggers, course over time, disability). Most studies were interested in the association of cognitive-emotional symptoms (e.g., internalizing symptoms, anxiety) and their relation to headache, including a meta-analysis. In nearly all studies, a close bond between negative affectivity and headache, especially migraine, was revealed.
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