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S T U D Y P R O T O C O L Open Access
Protocol for a randomized pilot study (FIRS
T STEPS): implementation of the Incredible
Years-ASLD® program in Spanish children
with autism and preterm children with
communication and/or socialization
difficulties
Fátima Valencia
1
, Elena Urbiola
1
, Marina Romero-González
2,3*
, Inmaculada Navas
2
, María Elías
4
, Alexandra Garriz
1
,
Almudena Ramírez
2,3
and Laia Villalta
4,5
Abstract
Having access to parenting interventions in the early years is key to improve the developmental outcomes of
children with neurodevelopmental problems. The Incredible Years® (IY) Parent Program is a group intervention that
has demonstrated efficacy in terms of reducing stress in parents, as well as improving behavioral, emotional, and
social outcomes in children. The program has been recently adapted for families of children with autism or
language delays (IY-ASLD®). This intervention has not yet been implemented in the Spanish Public Health System,
where there is a scarcity of evidence-based interventions being offered to families with young children presenting
neurodevelopmental problems. The main aims of this study are to determine the feasibility of implementing the IY-
ASLD® program within Spanish Child Mental Health Services and to examine parents’acceptability and satisfaction
with the intervention. As a secondary objective, we aim to evaluate its preliminary effectiveness in terms of
reducing parental stress and behavioral difficulties in their children. The FIRST STEPS study is a multicenter, pilot
randomized controlled trial comparing the IY-ASLD® program with a treatment-as-usual (TAU) condition.
Approximately 70 families of children with autism spectrum disorder (ASD) and preterm children with
communication and/or socialization difficulties (aged 2–5 years) will be recruited. Families will be assessed prior to
randomization and after the intervention. Due to the COVID-19 pandemic, the intervention will consist of 22 weekly
online sessions (approximately 6 months).
The FIRST STEPS pilot trial will demonstrate the feasibility and acceptability of reliably implementing the IY-ASLD®
program within the Spanish Public Health System. The results of this study could represent the first step to inform
(Continued on next page)
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* Correspondence: marinarglez@gmail.com
2
Maternity Hospital, Hospital Regional Universitario de Málaga, Málaga, Spain
3
Department of Brain Health, CIMES, Faculty of Medicine-IBIMA, UMA,
Málaga, Spain
Full list of author information is available at the end of the article
Valencia et al. Trials (2021) 22:291
https://doi.org/10.1186/s13063-021-05229-1
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(Continued from previous page)
policymakers in Spain when designing evidence-based healthcare pathways for families of children presenting ASD
symptoms or neurodevelopmental difficulties at early stages.
Trial registration: ClinicalTrials.gov NCT04358484. Registered on 04 April 2020
Keywords: Parenting intervention, Pilot, ASD, Preterm children, Child development, randomized controlled trial,
Complex intervention
Introduction
Autism spectrum disorder (ASD) is a neurodevelop-
mental disorder involving social communication dis-
turbances and a restricted pattern of interests, present
before age 3 [1].
Preterm children are at particular risk of presenting a
broad range of developmental difficulties, such as lan-
guage delay, communication and social disturbances,
and ASD [2–4]. Both children with ASD and preterm
children are more likely to exhibit internalizing and ex-
ternalizing difficulties early in life [5–8].
The persistence of conduct problems in these young
children has implications for their developmental trajec-
tory, including the emergence of comorbid mental disor-
ders, social problems, and future maladaptation [9,10].
Early intervention is crucial to improve these chil-
dren’s outcomes. At the early stages of development,
troubling signs (e.g., communication difficulties) can be
targeted and treated with no need to wait for a full-
blown diagnosis. This approach allows treatment to
reach toddlers with a wide range of neurodevelopmental
difficulties, preventing interventions to be limited to par-
ticular diagnostic categories.
Parent-mediated interventions can have a large and
sustained effect at a relatively low cost [11], improving a
broad range of developmental domains [12]. Also, caring
for children with neurodevelopmental disorders can be
very stressful for parents, which could in turn lead to
the lower effectiveness of interventions [13] and parental
mental health problems [14]. Thus, it is of utmost im-
portance to support the parents of these children in their
task of promoting their children’s development [15,16].
With this aim, evidence-based parenting interventions
have been developed for children with ASD symptoms
and for preterm children [12,17]. However, these inter-
ventions are insufficiently available within the Spanish
Public Health System.
Group interventions (the Incredible Years Autism
Spectrum and Language Delays program: IY-ASLD®)
Group interventions show promise as a valuable
resource to help parents cope with children’s behavioral,
social, and emotional difficulties. This therapeutic
approach has demonstrated effectiveness in terms of
improving dysfunctional parenting styles, reducing
children’s behavioral problems [18] and increasing
parents’ability to facilitate their children’s communica-
tion skills and vocabulary [19,20]. Group interventions
also provide social support for parents [21,22]. This is
especially important for parents who are more likely to
experience depression and stress during the early years
of their child’s life. This is the case for parents of chil-
dren with ASD [23,24] and those of preterm children
[25], who have identified a need for parenting support to
promote their children’s development [26].
The Incredible Years® parenting programs [27] are a
set of interventions recommended by the NICE guide-
lines [28], primarily focused on strengthening the
parent-child interaction and improving parenting skills
in order to prevent or reduce children’s behavioral prob-
lems. The effectiveness of the Incredible Years program
has been widely demonstrated in multiple randomized
controlled trials, showing an improvement in terms of
parental stress levels, depression, and parental coping, as
well as in children’s behavior difficulties [29,30]. A
range of developmentally appropriate interventions for
different age groups is offered.
The IY-ASLD® program has been specifically devel-
oped to target the needs and concerns of parents of chil-
dren aged 2–5 years in the autistic spectrum or with
language delays [15]. The program encourages positive
parent-child relationships to promote children’s emotion
regulation, social competence, language skills, school
readiness, and peer relationships. The intervention tea-
ches parents how to play in a child-directed way but
with a specific focus on encouraging children’s commu-
nication and social engagement. It also focuses on how
to use positive discipline to set limits and handle misbe-
havior. A pragmatic randomized controlled trial has
been recently published, supporting the feasibility of
delivering this intervention in the UK National Health
Service (NHS) and showing good levels of acceptability,
compliance, and fidelity to the program [31].
The IY-ASLD® program has never been trialed in
Spain, where the Public Health System has shown a lack
of resources to perform evidence-based early interven-
tions for neurodevelopmental problems [32]. Thus, the
validation and implementation of group interventions
such as the IY-ASLD® program are a priority in terms of
offering Spanish families better and earlier interventions
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that are brief, intensive, cost-effective, and based on
scientific evidence.
Aims and hypotheses
The main aim of the present study is to examine the
feasibility of implementing the IY-ASLD® program in the
Spanish Public Health System. Secondarily, we aim to
explore initial evidence of the effects of treating parents
of preschool children with ASD and preterm children
with communication and/or socialization difficulties.
In relation to the primary objective, the research
hypotheses are as follows:
I. It is possible to recruit and randomize families to an
intervention group and a TAU condition.
II. Parents accept to participate in the program.
III. Parents’compliance with the program is acceptable
(attending at least 15 of the 22 sessions and a
minimum of 50% of parents finishing the
intervention).
IV. Parents report acceptable levels of satisfaction with
the program.
V. The program can be reliably implemented in the
Spanish Public Health System.
In relation to the secondary objective, the research hy-
potheses are as follows:
I. Parents who received the intervention present
reduced levels of parental stress when compared to
the control group.
II. Parents who received the intervention show
reduced levels of depressive symptoms and
expressed emotions when compared to the control
group.
III. Parents who received the intervention present an
increase in their positive parenting skills when
compared to the control group.
IV. Parents who received the intervention report a
decrease in the levels of children’s externalizing and
internalizing symptoms when compared to the
control group.
In order to achieve these goals, we designed a con-
trolled randomized pilot study that will be conducted
within the Spanish Public Health System, where partici-
pating families will be randomly allocated to the inter-
vention group (receiving the IY-ASLD® program) or to
the treatment as usual condition (TAU) on a 1:1 ratio.
Methods
This is a multicentric study that will be carried out in
Child and Adolescent Mental Health Services from three
hospitals in Spain: Hospital Materno-Infantil in Málaga
(HMIM), Hospital General Universitario Gregorio
Marañón in Madrid (HGUGM), and Hospital Sant Joan
de Déu in Barcelona (HSJD). Eligible participants will be
parents of children diagnosed with ASD and parents of
preterm children with communication and/or
socialization difficulties.
Sample size
The IY-ASLD® program will be implemented in Child
and Adolescent Mental Health Services at each site. In
two of them (HMIM and HGUGM), parents of children
with ASD will be recruited (n= 48), and in one site
(HSJD), parents of preterm children with communica-
tion and/or socialization difficulties will be included
(n= 24). Participating families will be randomly allocated
to the TAU condition or to the intervention group
within each site.
For the sample size calculation, we used the outcome
parental stress, measured through the questionnaire
Parental Stress Index Short Form (PSI-SF) [33]. This is a
36-item scale, with a range of 180 points. There is data
showing that a decrease of 16.5 points in the total scale
stress score can be seen after attending an IY program
[34]. Given that this study will be conducted with par-
ents of children presenting neurodevelopmental difficul-
ties, we anticipated that the decrease in the PSI-SF score
would be lower. We estimated the necessary sample size
considering a power of 80%, α= 0.05, a difference be-
tween pre- and post-test of 10 points, and a standard de-
viation of 20 [35], using a paired-samples ttest. We
estimated 34 participants needed per arm of the study.
Thus, we aim to recruit approximately 70 participants.
The drop-out rate has not been included when calculat-
ing the sample size, considering that a sample of 70 par-
ticipants is similar or larger than previous pilot or
feasibility studies [31,36] and in line with recommenda-
tions by the National Institute of Health Research [37].
Moreover, previous studies involving interventions with
parents of children with neurodevelopmental disorders
have reported low attrition rates [18,31,36].
Eligibility criteria
Different inclusion criteria were introduced for each site,
given that the study was conducted in specialist ASD
units in the HMIM and HGUGM sites, and in a special-
ized unit for preterm children at risk of developmental
disorders in the HSJD site.
The following are the inclusion criteria:
1. (a) HMlM and HGUGM sites: parents/caregivers of
children diagnosed with ASD (clinical diagnosis
performed by psychiatrists or clinical psychologists
in the service, based on DSM-5 diagnostic criteria),
(b) HSJD site: parents/caregivers of preterm
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children (< 37 weeks of gestational age) with com-
munication and/or socialization difficulties (defined
as Vineland-III scores below 1SD in any of the com-
munication or socialization subdomains)
2. Children aged 2–5 years
3. Parents/caregivers showing good understanding of
the Spanish language
4. Parents/caregivers consenting to take part in the
study and signing the informed consent
The following are the exclusion criteria:
1. Attending another structured parenting program
(focused on improving parental strategies to help
their children with their developmental or
regulation difficulties) during the intervention phase
of the study
2. Children in the care of their local authority
Recruitment
Parents/caregivers will be recruited between January
and March 2020 within the Child and Adolescent
Mental Health Services of each hospital site, where
patients have previously been assisted for their neuro-
developmental difficulties (Fig. 1). A leaflet with the
inclusion and exclusion criteria will be handed out to
clinicians working in the services. A short recruitment
period has been anticipated, given that the study will
be conducted in regional units with a high number of
referrals and the study researchers work in close
collaboration with clinicians. Clinicians will be asked
to discuss the study with eligible families and will ask
the families permission to be contacted by the study
researchers. If they agree to be contacted about the
project, a research assistant will call the family to
discuss the study further. If the family is interested in
participating in the study and meets the inclusion cri-
teria, an appointment will be made with parents to
sign the informed consent and to complete the pre-
intervention assessment. During this visit, researchers
will make sure that participants receive all the neces-
sary information and have the opportunity to ask any
questions. Participants will be able to discontinue the
treatment sessions or drop out from the control
groupatanypointattheirrequest.
Randomization
Randomization will take place once all the participat-
ing families have completed baseline measures. Then,
they will be randomly allocated to the intervention
group or to the TAU condition within each center.
Randomization will be conducted using the Program
R 3.6.2 (R Foundation for Statistical Computing),
generating a replicable process fixing a random seed.
Allocation will be stratified by developmental level,
considering two levels above and below IQ = 70
(assessed with cognition subscale of the Develop-
mental Profile-3) [38].
An independent researcher will carry out the
randomization process, and researchers who are respon-
sible for patient recruitment or for intervention delivery
will not be involved. Due to the pragmatic and clinically
focused nature of the study, further blinding procedures
will not be possible.
Fig. 1 Participant flow diagram
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Intervention
The IY-ASLD® program is a 14-session group-based
intervention for parents of children presenting neurode-
velopmental difficulties. Due to the COVID-19 pan-
demic, the intervention will be adapted to be performed
online in accordance with the Incredible Years devel-
opers, who will provide training and supervision to
group leaders. The online format requires 22 sessions
(approximately 6 months). Each online group will in-
clude approximately 5–6 participants. One of the main
principles of the intervention is the collaborative ap-
proach, promoting parents’discussion around the topics
of interest and facilitating a solution-based perspective.
The intervention includes video modeling and empha-
sizes the importance of practice-based learning through
role-playing. The IY-ASLD® program takes into consid-
eration the different developmental levels of each child
and pairs parents according to this variable in role-play
and other one-to-one discussions. Weekly home tasks
will be assigned to parents, and families will be phoned
each week to encourage home-based practice [15].
Fidelity to the treatment manual will be ensured in dif-
ferent ways. Group interventions will be conducted by
experimented clinicians (child and adolescent psychia-
trists and clinical psychologists), officially trained in the
IY-ASLD® model by an accredited trainer. Group leaders
will complete weekly checklists regarding fidelity to the
intervention and participants will also complete weekly
parent evaluations. Group leaders will be supervised by
certified supervisors and will pursue accreditation
according to the IY-ASLD® program standards.
The TAU condition involves outpatient appointments
with a clinical psychologist or a psychiatrist, including
unstructured interventions to foster children’s develop-
ment and/or drug prescription when needed. Many fam-
ilies receive other interventions out of the National
Health System (e.g., Early Development Centers), infor-
mation that will be collected in the baseline assessment.
Families allocated to the intervention group will also re-
ceive TAU.
Measures (Table 1)
Baseline and sample descriptors
At baseline, the following sociodemographic and child
clinical variables will be assessed: family structure, child’s
age, gender, medical conditions, type and date of psychi-
atric diagnosis, psychotropic medication, educational
status, current and past mental health interventions for
parents and for the child, and neurodevelopmental prob-
lems in siblings. Socioeconomic status will be deter-
mined using Hollingdale’s Index of Social Position [39].
At baseline, the following questionnaires will be
administered:
The Modified Checklist for Autism in Toddlers-
Revised with Follow-up (M-CHAT-R/F) [40]: this tool is
a parent-reported 20-item questionnaire screening ASD
symptoms in children aged 24–30 months. This instru-
ment will be administered before the intervention to
describe children’s social communication difficulties.
The Spanish translation has shown valid and reliable
results.
Social Communication Questionnaire (SCQ) [41]: it is
a 40-item parent report measure, yes/no format, based
on the Autism Diagnostic Interview-Revised (ADI-R)
[42]. The Lifetime version of this questionnaire will be
administered before the intervention with the same aim
as the M-CHAT-R, in children aged between 30 months
and 5 years. It is a robust tool that has shown good
validity, and it has been widely adopted by both the
research and clinical community.
Vineland Adaptive Behavior Scale-III (VABS-III, par-
ent/caregiver report form) [43]: it assesses adaptive func-
tioning in different areas: communication (receptive,
expressive, written), socialization (interpersonal/play and
leisure time/coping), daily living skills (personal, domes-
tic, community), and motor skills (fine and gross). It also
generates a final adaptive composite score. This instru-
ment will be used before the intervention to collect the
level of functioning in different developmental areas. It
has been considered a very efficient tool to measure the
adaptive behavior profile of preschool children with de-
velopmental problems and shown an excellent test-retest
reliability [44].
Developmental Profile-3 (DP-3) [38]: this is a 180-item
parental questionnaire assessing developmental delays in
different domains: motor, adaptative, socio-emotional,
cognitive, and communication. It also computes an over-
all general development score. It will be used before the
intervention to collect the child developmental level. It
has shown good internal consistency.
Primary outcomes (feasibility)
Parents’engagement with the program and participant
retention will be monitored throughout, expecting they
will attend at least 15/22 sessions with a minimum of
50% of parents finishing the program.
Autism Program Parent Weekly Evaluation [45]: this
instrument is part of the IY-ASLD® program materials
and will be used to collect information regarding com-
pliance and satisfaction throughout the study.
Autism Program Parent Final Satisfaction Question-
naire [45]: this questionnaire is included within the
IY-ASLD® program. It will be used to measure the
acceptability and satisfaction with the intervention
after the last session. It covers five areas: (1) the over-
all program, (2) usefulness of teaching format, (3)
usefulness of specific teaching strategies, (4)
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evaluation of the group facilitators, and (5) the parent
group.
Implementation fidelity will be ensured and monitored
throughout the intervention process, following the
strategies described above.
Secondary outcomes (preliminary effectiveness for parental
outcomes)
ASD-P Parent Strategies Questionnaire [45]: this is a 60-
item questionnaire included within the IY-ASLD® pro-
gram. It is divided into 5 subdomains regarding the dif-
ferent strategies that will be learned throughout the
program to promote social, emotional, language, and
academic development, and how often parents use these
strategies. This tool will be administered before and after
the program implementation.
Parent Stress Inventory-Short Form (PSI-SF) [33]: this
is a 36-item questionnaire that specifically focuses on
assessing parental stress associated with the care of their
offspring. It has three domains: parental distress, parent-
child dysfunctional interaction, and difficult child, which
combine to form a total stress scale. This tool will be
administered before and after the intervention. It has
shown good internal consistency.
Beck Depression Inventory (BDI) [46]: this is a 21-
item screening tool assessing the severity of depressive
symptoms. It is a standardized and validated question-
naire, often used in mood disorder assessments. It will
be collected before and after the intervention. It has
good reliability.
Alabama Parenting Questionnaire-Preschool revision
(APQ-Pr) [47]: this is a 32-item parent-reported ques-
tionnaire measuring parenting practices that are consist-
ently associated with disruptive child behaviors. This
version has 3 dimensions: positive parenting, inconsist-
ent parenting, and punitive parenting. It will be collected
before and after the intervention. This measure has
shown good internal consistency and validity.
Table 1 Overview of the study timeline and measures
Time points Study period
Enrolment Allocation Re-assessment Weekly intervention (22
sessions)
Close-out
January to February
2020
March
2020
September
2020
September
2020
Session 1
March
2021
Session 22
May
2021
Enrollment:
Eligibility screen X
Informed consent X
Allocation X
Intervention:
IY-ASLD® group XXXXXX
TAU group XXX X
Assessments:
Baseline variables:
Sociodemographic variables: Hollingdale’s Index of
Social Position [39]
X
The Modified Checklist for Autism in Toddlers-Revised
(M-CHAT-R) [40]
X
Social Communication Questionnaire (SCQ) [41]X
Vineland Adaptive Behavior Scale-III (parent/caregiver
report form) [43]
X
Developmental Profile-3 (DP-3) [38]X
Outcome variables:
Parent Stress Inventory-Short Form (PSI-SF) [33]XX X
Beck Depression Inventory (BDI) [46]XX X
Alabama Parenting Questionnaire-Preschool version
(APQ-Pr) [47]
XX
Autism-Specific Five Minute Speech Sample (AS-FMFSS) [48]XX
Child Behavior Checklist (CBCL 1.5-5) [50]XX
ASD-P Parent Strategies Questionnaire [45]XX
Autism Program Parent Final Satisfaction Questionnaire [45]XX
Autism Program Parent Weekly Evaluation [45]XX
IY-ASLD® Incredible Years Autism Spectrum and Language Delays program®, TAU treatment as usual
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Autism-Specific Five Minute Speech Sample (AS-
FMFSS) [48]: this is a narrative 5-min interview used to
measure parental-expressed emotions for children with
ASD and related disorders.Parents are asked to speak
about their child and the parent-child relationship —“I’d
like you to speak for 5 minutes, telling me what kind of
person (child name) is and how the two of you have got
along together over the past 6 months.”Speech samples
are audiotaped, transcribed, and coded following four
global categories: (a) initial statement, (b) warmth, (c) re-
lationship, (d) emotional over-involvement, (e) critical
comments, and (f) positive comments. Expressed emo-
tions will be measured before and after the intervention.
Benson et al. [49] assessed 30 randomly selected speech
samples by three different raters. Inter-rater reliability
and code-recode reliability on two separate occasions,
for all six AS-FMSS components and for total EE score,
were both in the good to excellent range.
Other outcomes (preliminary effectiveness for child
outcomes)
Child Behavior Checklist (CBCL 1.5-5) [50]: this is a
parent-reported 99-item inventory that addresses spe-
cific externalizing and internalizing behaviors. The sum
of scores forms a total problem score, and it also in-
cludes scores for externalizing and internalizing difficul-
ties subdomains. It will be collected before and after the
intervention. It has shown good internal consistency,
also in children diagnosed with ASD [51].
Data collection
Data will be collected at baseline (before performing
randomization), right before the beginning of the inter-
vention and after finishing the IY-ASLD® intervention.
Due to the COVID-19 pandemic, the intervention has
been postponed 6 months (from March 2020 to Septem-
ber 2020), and families will be re-assessed before the
start of the group for an updated measure of parental
depressive symptoms and stress. Parents consenting to
participate (mother, father, or both) will be offered a
hospital appointment before and after the intervention
with a research assistant to complete the assessment,
including self-report measures, children outcome mea-
sures, and a voice recording for the ASFMSS tool. If
both parents participate in the study, they will fill out
the children’s outcome measures together (by consen-
sus) and the parental outcome measures individually.
Those parents who discontinue or deviate from the
intervention protocols will receive a telephone call from
the research assistant to arrange further hospital
appointments or to check if they are willing to complete
the questionnaires for the main outcomes on the phone.
The timeline for participants’enrollment, data collec-
tion, and the conduction of the intervention are
scheduled in Table 1.
Data analysis
Descriptive analysis will be used for primary outcomes
(e.g., recruitment rates, number of sessions attended by
participants, proportion attending at least 15 out of 22
sessions, and proportion finishing the program). Attri-
tion and satisfaction rates with the program will be also
described.
Differences (if any) in baseline and descriptive vari-
ables between intervention and TAU conditions will be
described. Between-site differences will be analyzed with
the chi-square and independent samples ttests and will
be controlled for in the main analyses.
For secondary outcomes, the analysis will follow an
intention-to-treat basis. Regarding parental stress and
depression, the assessment taken right before the inter-
vention begins will be the one included in the analysis.
Differences between the treatment groups in terms of
parental levels of stress, expressed emotions, and parent-
ing practices will be determined with the analysis of co-
variance (ANCOVA). Relevant confounding variables,
such as socio-demographic variables, cognitive level at
baseline, or treatment site, will be added as covariates.
We will also estimate 95% confidence intervals and ef-
fect sizes [52]. Further secondary analysis will use similar
methods to compare treatment groups regarding add-
itional child outcomes (i.e., CBCL externalizing
problems).
Missing data (i.e., missing item responses in question-
naires) will be treated following the instructions stipu-
lated in the questionnaire’s manual. Imputation methods
will be considered for full-case missing data. The ana-
lysis will be conducted using the SPSS/STATA statistical
packages.
Data monitoring
The study does not involve any anticipated risks for par-
ticipants, and therefore, there is not an external Data
Monitoring Committee involved. There are no stopping
guidelines for the trial, but participants can withdraw
consent at any time.
Trial status
The protocol for the current pilot study was registered
in ClinicalTrials.gov (ID number: NCT04358484. Unique
Protocol ID: PIC-220-19) and it was released in April
2020. The study began in January 2020, and the antici-
pated finish date is May 2021. The recruitment process
was carried out during the same period in the 3 sites,
from 3 February 2020 to 2 March 2020. Due to the
COVID-19 pandemic, the intervention has been
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postponed to September 2020, and baseline measures
(parental depressive symptoms and stress) will be
repeated before the intervention begins.
Ethics
The study has received ethical approval from the Ethics
Committee at each site (PIC-220-19): CEIm Fundaciò
Sant Joan de Déu (Barcelona), CEI provincial (Málaga),
and CEIm Hospital Gregorio Marañón (Madrid). The
trial data set will be stored in institutional encrypted
computers and will itself be encrypted with a password.
Only the staff involved in the study will be authorized to
access the data. Participants will be informed about all
protection data procedures and will be able to disengage
from the study at any point, without affecting their usual
clinical care. Written information regarding these as-
pects will be handed, and contact details from research
assistants will be offered in order to clarify any doubts
or worries participants might have.
Participants will be informed of the potential benefits
and risks of participating in the study. Due to the nature
of the study, it is unlikely that taking part in the research
will result in any damage. After families are provided
with sufficient information about the project, they will
be asked to sign the written informed consent.
The study will be conducted following the principles
developed by the World Medical Association, outlined
in the Declaration of Helsinki.
Dissemination plans
The results of this study will inform the acceptability
and feasibility of implementing, and culturally adapting,
the IY-ASLD® intervention for Spanish families. The re-
sults will be described in a final report to the funder,
and they will be published in peer-reviewed journals.
Discussion
The main aim of the study is to pilot the IY-ASLD®
intervention in Public Mental Health Services in Spain.
The current study has several strengths. Firstly, to the
best of our knowledge, this is the first time that this pro-
gram will be conducted in Spain. This is relevant in
terms of improving the availability of treatments for chil-
dren with neurodevelopmental difficulties within the
Spanish Public Health System. Also, given that this
intervention has been designed and tested in other coun-
tries (the USA and the UK), it is important to test if it
can be implemented in Spain, where we have language,
cultural, and healthcare system differences. Moreover,
the IY-ASLD® program will be tested in different areas
within Spain, providing a broad view of its feasibility
across the country. Secondly, the present study targets a
broad range of patients with early neurodevelopmental
problems, as not only those meeting the diagnostic
criteria for ASD are included, but parents of premature
children with socialization and/or communication diffi-
culties are also offered the intervention. Different strat-
egies have been put into place in order to provide
coherence and internal consistency to the study. Group
leaders have attended the official training and will be fol-
lowing the procedures established in the program to as-
sure fidelity to the intervention. Finally, preliminary
efficacy will be analyzed, which could inform the import-
ance of conducting a larger randomized controlled trial.
Regarding limitations, the sample size might be limited
in terms of power for some effect analyses, considering
that the trial has not been powered for between-group
differences. However, it is of note that we are introdu-
cing validated measures that go beyond parent-reported
questionnaires to assess parent-child relationships (i.e.,
ASFMFSS), which is of paramount importance when
evaluating parenting interventions and children in pre-
school years. Another limitation is the repetition of the
assessment of parental stress and depression (due to the
COVID-19 pandemic) once parents already know their
group allocation.
This trial will represent the first step to plan future
projects. Positive results regarding feasibility (primary
outcome) will be required to conduct a larger RCT. The
limited sample size might not allow detecting significant
differences regarding preliminary efficacy (secondary
outcome). A larger RCT could guide policymakers to
fund and further implement the intervention within the
Spanish Public Health System.
Supplementary Information
Supplementary information accompanies this paper at https://doi.org/10.
1186/s13063-021-05229-1.
Additional file 1. Consent form for participants.
Additional file 2. Information sheet for participants.
Acknowledgements
Not applicable.
Protocol amendments
Protocol amendments will be decided in coordination between the (co)
principal investigators at the three sites and will be then notified to the
sponsor and the funder. Any deviations from the protocol will be fully
documented using a breach report form. The clinical trial registry will be
modified accordingly.
Post-trial care
There is no anticipated harm and compensation for trial participation. There
is no provision for post-trial care.
Sponsor
The sponsor/collaborator for the study is Fundació Sant Joan de Déu. Phone:
0034 93 600 97 51. Email: ceic@fsjd.org. The sponsor provided logistic and
human resources support and played no part in the study design; collection,
management, analysis, and interpretation of the data; writing of the report;
and decision to submit the report for publication.
Valencia et al. Trials (2021) 22:291 Page 8 of 10
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
The study involves one principal investigator based in Hospital Sant Joan de
Dèu (Barcelona) and two co-principal investigators based in HGU Gregorio
Marañon (Madrid) and Hospital Materno Infantil (Málaga). Each (co) principal
investigator is responsible for managing and coordinating the study at each
site. A research psychologist is responsible at each site of the recruitment, as-
sessment, and obtaining consent, supervised by the main investigators. Re-
searchers at each site hold weekly meetings for coordination purposes, and
the three leading investigators meet monthly for coordination and to ensure
consistency between sites. The study has not been supervised by any exter-
nal organization.
Authors’contributions
FV, MR-G, and LV conceived and designed the study. FV, MR-G, LV, EU, IN,
and ME conducted the study. AG and AR collected the recruitment data. FV,
MR-G, LV, and EU drafted the manuscript. All authors critically reviewed the
manuscript and were responsible for its final approval. All authors had full ac-
cess to the study data and can take responsibility for the integrity and the
accuracy of the data. FV, MR-G, and LV are the guarantors for the study. All
named authors adhere to the authorship guidelines of Trials, and no profes-
sional writers have been involved. All authors have agreed to publication.
Funding
This paper reports on independent research financially supported by the
Alicia Koplowitz Foundation. The funder played no part in the study design;
collection, management, analysis, and interpretation of the data; writing of
the report; and decision to submit the report for publication.
Availability of data and materials
As mentioned above, the trial data set will be stored in institutional
encrypted computers and will itself be encrypted with a password. Only the
staff involved in the study will be authorized to access the data. The data
sets analyzed during the current study are available from the corresponding
author on reasonable request.
Declarations
Ethics approval and consent to participate
As mentioned above, the study received ethical approval from the Ethics
Committee at each of the three sites. After providing the families with
sufficient verbal and written information about the project (including all
protection data procedures, the potential benefits and risks of participating
in the study, and the option to disengage from the study at any point
without affecting their usual clinical care), they will be asked to sign the
written informed consent.
The study will be conducted following the principles developed by the
World Medical Association, outlined in the Declaration of Helsinki.
Consent for publication
Before signing in the consent form, all participant families will be provided
with written information about the study. This includes the aims of the
study, families’voluntary participation, the duration of the study, the timeline
of families’participation, the potential risks and benefits of participating in
the study, all data protection measures, and their consent for including
anonymous study data on scientific publications.
On the consent form, participants will be asked if they agree to the use of
their data should they choose to withdraw from the trial. Participants will
also be asked for permission for the research team to share relevant data
with other team members or the Incredible Years team for supervision
purposes. This trial does not involve collecting biological specimens for
storage.
Competing interests
The views expressed in this publication are those of the authors, and they all
report no potential conflict of interest.
Author details
1
Department of Child and Adolescent Psychiatry, Institute of Psychiatry and
Mental Health, Hospital General Universitario Gregorio Marañón, Madrid,
Spain.
2
Maternity Hospital, Hospital Regional Universitario de Málaga, Málaga,
Spain.
3
Department of Brain Health, CIMES, Faculty of Medicine-IBIMA, UMA,
Málaga, Spain.
4
Department of Psychiatry and Psychology, Hospital Sant Joan
de Déu de Barcelona, L’Hospitalet de Llobregat, Spain.
5
Children and
Adolescent Mental Health Research Group, Research Institute Sant Joan de
Déu, Esplugues de Llobregat, Spain.
Received: 28 July 2020 Accepted: 27 March 2021
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