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

NCT ID: NCT06125093

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-14
• Study Completion Date: 2024-09-16

Brief 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. 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.

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.

Conditions

Genetic Syndrome; Language Development; Autism or Autistic Traits; Parenting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

Those 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).

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

Treatment as usual (TAU) group

The 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Parenting intervention

Eligibility Criteria

Inclusion Criteria

1. Children aged 3.0 - 7.11 years at recruitment

2. Children with a diagnosis or in diagnostic process for high suspicion of a genetic abnormality

3. 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).

4. 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).

5. Parents/caregivers showing good understanding of the Spanish or Catalan language

6. Parents/caregivers consenting to take part in the study and signing the informed consent

Exclusion Criteria

1. Children diagnosed with an Autism Spectrum Disorder

2. Children scoring above diagnostic cut-off for Autism or Autism Spectrum Disorder in the ADOS-2.

3. Attending another structured parenting program

4. Children in the care of their local authority

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: collaborator

Parc Taulí Hospital Universitari

OTHER

Sponsor Role: collaborator

Fundació La Marató de TV3

OTHER

Sponsor Role: collaborator

Fundació Sant Joan de Déu

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laia Villalta, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Sant Joan de Déu. Fundació Privada per a la Recerca i la Docència Sant Joan de Déu

Anna Maria Cueto-González, MD

Role: STUDY_CHAIR

Hospital Universitari Vall d'Hebron. Vall d'Hebron Institut de Recerca

Carmen Manso, MD

Role: STUDY_CHAIR

Parc Taulí Hospital Universitari

Mercedes Serrano, MD, PhD

Role: STUDY_CHAIR

Hospital Sant Joan de Deu

Locations

Sant Joan de Deu

Esplugues de Llobregat, Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Hospital Universitari Parc Taulí

Sabadell, , Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 33879224 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29537331 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29774207 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26341300 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26375193 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31961490 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39033111 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

434/U/2022

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PIC-168-22

Identifier Type: -

Identifier Source: org_study_id