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Genetic SyndromeThe GAPNCT06125093

Study of an Early Parenting Intervention for Children With Genetic Abnormalities and Mental Health Problems

A study testing Incredible Years Autism Spectrum and Language Delays Parent Program (IY-ASLD®) in people with Genetic Syndrome and Language Development, run by Fundació Sant Joan de Déu at 3 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The GAP study is a randomized controlled trial that aims to determine the feasibility and efficacy of the "Incredible Years Autism Spectrum and Language Delays" (IY-ASLD®) intervention for families of children with developmental problems from a genetic basis. Read more about this study

Who is it for?
Ages 3 to 7 years
What is being tested?
Incredible Years Autism Spectrum and Language Delays Parent Program (IY-ASLD®)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
3 sitesSpain
Study dates
14 Mar 2023to 16 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 7 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children aged 3.0 - 7.11 years at recruitment
  • Children with a diagnosis or in diagnostic process for high suspicion of a genetic abnormality
  • For children up to 5.11 years with withdrawn (defined as CBCL/1.5-5 scores above the borderline clinical range, T-score> 65) AND/OR pervasive developmental problems (defined as CBCL/1.5-5 scores above the borderline clinical range, T-score> 65) AND/OR socialization difficulties (defined as Vineland-III scores below 1SD in the socialization subdomains).
  • For children over 6 years with social problems (defined as CBCL/6-18 scores above the borderline clinical range, T-score> 65) AND/OR thought problems (defined as CBCL/6-18 scores above the borderline clinical range, T-score> 65) AND/OR socialization difficulties (defined as Vineland-III scores below 1SD in the socialization subdomains).
  • Parents/caregivers showing good understanding of the Spanish or Catalan language
  • Parents/caregivers consenting to take part in the study and signing the informed consent

Who cannot join

  • Children diagnosed with an Autism Spectrum Disorder
  • Children scoring above diagnostic cut-off for Autism or Autism Spectrum Disorder in the ADOS-2.
  • Attending another structured parenting program
  • Children in the care of their local authority

Trial locations and contacts

3 sites in 1 country.

Spain3 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • Sant Joan de Deu

    Esplugues de Llobregat, Barcelona, 08950

  • Hospital Universitari Parc Taulí

    Sabadell

Other trials in Spain

About this study

Official title: Early Treatment for Children With Mental Health Problems and Genetic Abnormalities Through a Parenting Intervention (The GAP): A Pragmatic Randomized Controlled Trial

The GAP study is a randomized controlled trial that aims to determine the feasibility and efficacy of the "Incredible Years Autism Spectrum and Language Delays" (IY-ASLD®) intervention for families of children with developmental problems from a genetic basis. It is a multicentric trial where families will randomly be assigned to the intervention group or to a control group (they will follow their usual treatment). The intervention will be carried out in an online format, and it will involve 22 weekly group sessions. The results of The GAP study will help clinicians and policy makers in guiding towards evidence-based treatment options for these particularly vulnerable group of infants.

Read the detailed description

Children born with genetic abnormalities have higher risk of presenting developmental and mental health problems. Their parents tend to express higher anxiety levels, as parenting children with developmental problems can be a stressful challenge for many families. These infants can present important behaviour, emotion regulation and social interaction problems. These problems usually have a complex clinical presentation determined by their genetic abnormality. Despite many of their impairing symptoms can overlap with the characteristics of the Autism Spectrum Disorder (ASD), in many cases they do not meet criteria for a full-blown ASD diagnosis. These patients are placed in a double disadvantaged situation, as on top of suffering a genetic disease, they do not usually enter the ASD care-pathways and do not have access to effective therapies for their impairing symptoms. This problem should be addressed, as there is wide scientific evidence on early parenting programs that improve infants' developmental problems and parents' mental health. These parenting programs are structured interventions that provide parenting skills to improve the acquisition of children's social and emotion regulation abilities. Such interventions have been widely implemented internationally, but unfortunately, most families treated within our mental health system still do not have access to them. A good example is the parenting program "Incredible Years Autism Spectrum and Language Delays (IY-ASLD®)", focused on improving young children's development and parental stress levels. Recently, the feasibility and acceptability of implementing this program in different areas of the national territory has been studied, with high satisfaction levels expressed by participant families (parents of children with language delays or ASD). However, the scientific evidence is very limited for children with developmental problems from a genetic basis, particularly for those with dysfunctional symptoms' that do not meet diagnostic threshold for an ASD diagnosis.

The GAP study aims to determine, for the first time, the feasibility and efficacy of the IY-ASLD® intervention for families of children with developmental problems from a genetic basis. It is a multicentric randomized controlled trial where families will randomly be assigned to the intervention group or to a control group (they will follow their usual treatment). As genetic abnormalities are rare, clinicians will carry out the intervention in an online format (22 weekly sessions), reaching out all affected families that live scattered throughout the national territory. The results of The GAP study will help clinicians and policy makers in guiding towards evidence-based treatment options for these particularly vulnerable group of infants.

Being tested
Incredible Years Autism Spectrum and Language Delays Parent Program (IY-ASLD®)
Keywords
early intervention, parenting, randomized controlled trial, pragmatic, genetic syndromes, mental health, development
Medical subject headings
Genetic Diseases, Inborn, Autistic Disorder, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Incredible Years Autism Spectrum and Language Delays Parent Program (IY-ASLD®)Behavioural

    Also called Parenting intervention

    The IY-ASLD® program is a weekly group-based intervention for parents of children presenting neurodevelopmental problems (ASD symptoms, communication or language difficulties). The group is formed by 6-10 parents, and it is led by a group leader and a co-therapist, trained in the model.

    The intervention is manualized. It includes video modelling and emphasizes the importance of practice-based learning through role-playing. The IY-ASLD® program takes into consideration 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.

    The intervention will be conducted online. Even though the IY-ASLD® original intervention comprises 14 sessions, the online format requires 22 weekly sessions.

    Fidelity to the intervention will be assessed in accordance with the regulations of the program.

Study groups in NCT06125093
Study groupRoleWhat they receive
Intervention groupExperimentalThose in the intervention group will participate in a weekly group-based online intervention for approximately 6 months (Incredible Years-Autism Spectrum and Language Delays Parent Program, IY-ASLD®). Families allocated to the intervention group will also receive treatment as usual (TAU).
Receives: Behavioral: Incredible Years Autism Spectrum and Language Delays Parent Program (IY-ASLD®)
Treatment as usual (TAU) groupNo interventionThe TAU condition involves outpatient appointments with different paediatric specialists in the hospitals of the 3 sites of the study. Depending on the patients' needs, some cases will be assisted in early years centers or child mental health centers based in the community.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of parents engaging with and finishing the program

    Parents' attendance at the sessions will be regeristered weekly with a sheet of attendance, with the aim to determine levels of compliance and engagement with the intervention. An attendance of at least 15/22 sessions is expected, with a minimum of 50% of parents finishing the program.

    Measured: Attendance sheet completed weekly throughout treatment (22 weeks total)

  2. Compliance and satisfaction throughout the study (Autism Program Parent Weekly Evaluation)

    Parents' compliance and satisfaction with the intervention will be assessed weekly after each session with the questionnaire "Autism Program Parent Weekly Evaluation", which is part of the IY-ASLD® program materials.

    Measured: Questionnaire administered to the intervention group weekly throughout treatment (22 weeks total)

  3. Parents' acceptability and satisfaction with the program (evaluated with the Autism Program Parent Final Satisfaction Questionnaire)

    Parents' acceptability and satisfaction with the program will be assessed with the Autism Program Parent Final Satisfaction Questionnaire (included within the IY-ASLD® program). Data will be collected after the last session of the intervention.

    Measured: Administered to the intervention group at treatment completion (approximately 22 weeks after baseline)

  4. Parents' overall experiences with the program (evaluated with individual interviews)

    Individual interviews will be conducted after the last session of the intervention to explore from a qualitative perspective: (1) parents' acceptability, satisfaction and overall experience with the intervention, and (2) parents' perceived changes in their parenting skills and parental distress after the intervention.

    Outcome measurements 3 and 4 will be combined to determine parents' experiences, acceptability and satisfaction with the program.

    Measured: Interviews to the participants of the intervention group at treatment completion (approximately 22 weeks after baseline)

Secondary outcomes (5)

  1. Changes from baseline to post-intervention in Parent Stress Inventory-Short Form (PSI-SF)

    The PSI-SF 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.

    Measured: Administered to the intervention and control group at baseline (prior to programme initiation) and at immediately after the intervention (approximately 22 weeks after baseline)

  2. Changes from baseline to post-intervention in Alabama Parenting Questionnaire-Preschool revision (APQ-Pr)

    The APQ-Pr is a 32-item parent-reported questionnaire measuring parenting practices that are consistently associated with disruptive child behaviors. This version has 3 dimensions: positive parenting, inconsistent parenting, and punitive parenting. It will be collected before and after the intervention. This measure has shown good internal consistency and validity.

    Measured: Administered to the intervention and control group at baseline (prior to programme initiation) and at immediately after the intervention (approximately 22 weeks after baseline)

  3. Changes from baseline to post-intervention in Beck Depression Inventory (BDI)

    The BDI is a 21-item screening tool assessing the severity of depressive symptoms. It is a standardized and validated questionnaire, often used in mood disorder assessments. It will be collected before and after the intervention. It has good reliability.

    Measured: Administered to the intervention and control group at baseline (prior to programme initiation) and at immediately after the intervention (approximately 22 weeks after baseline)

  4. Changes from baseline to post-intervention in Autism-Specific Five Minute Speech Sample (ASFMFSS)

    ASFMFSS 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. Speech samples are audiotaped, transcribed, and coded following four global categories: (a) initial statement, (b) warmth, (c) relationship, (d) emotional over-involvement, (e) critical comments, and (f) positive comments. Expressed emotions will be measured before and after the intervention. Inter-rater reliability and code-recode reliability of this measure have been shown to be good to excellent.

    Measured: Administered to the intervention and control group at baseline (prior to programme initiation) and at immediately after the intervention (approximately 22 weeks after baseline)

  5. Clinicians' experiences with the intervention delivered

    Individual interviews will be conducted after the last session with clinicians who delivered the intervention.

    Measured: Interviews to clinicians at treatment completion (approximately 22 weeks after baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2023
  2. Study start14 Mar 2023
  3. Primary completion16 Sep 2024
  4. Study completion16 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06125093
Sponsor's protocol ID
PIC-168-22
Other IDs
434/U/2022
Acronym
The GAP
Status last verified
Dec 2025
First submitted
23 Oct 2023
Last updated
10 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Valencia F, Urbiola E, Romero-Gonzalez M, Navas I, Elias M, Garriz A, Ramirez A, Villalta L. Protocol for a randomized pilot study (FIRST STEPS): implementation of the Incredible Years-ASLD(R) program in Spanish children with autism and preterm children with communication and/or socialization difficulties. Trials. 2021 Apr 20;22(1):291. doi: 10.1186/s13063-021-05229-1.

    PubMed 33879224

  • Landa RJ. Efficacy of early interventions for infants and young children with, and at risk for, autism spectrum disorders. Int Rev Psychiatry. 2018 Feb;30(1):25-39. doi: 10.1080/09540261.2018.1432574. Epub 2018 Mar 14.

    PubMed 29537331

  • Morel A, Peyroux E, Leleu A, Favre E, Franck N, Demily C. Overview of Social Cognitive Dysfunctions in Rare Developmental Syndromes With Psychiatric Phenotype. Front Pediatr. 2018 May 3;6:102. doi: 10.3389/fped.2018.00102. eCollection 2018.

    PubMed 29774207

  • Richards C, Jones C, Groves L, Moss J, Oliver C. Prevalence of autism spectrum disorder phenomenology in genetic disorders: a systematic review and meta-analysis. Lancet Psychiatry. 2015 Oct;2(10):909-16. doi: 10.1016/S2215-0366(15)00376-4. Epub 2015 Sep 1.

    PubMed 26341300

  • Webster-Stratton C, McCoy KP. Bringing The Incredible Years(R) Programs to Scale. New Dir Child Adolesc Dev. 2015 Fall;2015(149):81-95. doi: 10.1002/cad.20115.

    PubMed 26375193

  • Williams ME, Hastings RP, Hutchings J. The Incredible Years Autism Spectrum and Language Delays Parent Program: A Pragmatic, Feasibility Randomized Controlled Trial. Autism Res. 2020 Jun;13(6):1011-1022. doi: 10.1002/aur.2265. Epub 2020 Jan 21.

    PubMed 31961490

  • Serrano M, Elias M, Llorens M, Bolasell M, Vall-Roque H, Villalta L. Early treatment for children with mental health problems and genetic conditions through a parenting intervention (The GAP): study protocol for a pragmatic randomized controlled trial. Trials. 2024 Jul 20;25(1):496. doi: 10.1186/s13063-024-08278-4.

    PubMed 39033111

Questions about this trial

What is this clinical trial studying?

A study testing Incredible Years Autism Spectrum and Language Delays Parent Program (IY-ASLD®) in people with Genetic Syndrome and Language Development, run by Fundació Sant Joan de Déu at 3 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of parents engaging with and finishing the program (time frame: Attendance sheet completed weekly throughout treatment (22 weeks total)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06125093, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.

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