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

NCT06125093 | Completed

• 2 other identifiers: PIC-168-22434/U/2022
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

early intervention; parenting; randomized controlled trial; pragmatic; genetic syndromes; mental health; development

Outcome Measures

Primary Outcomes (4)

• 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.

  Attendance sheet completed weekly throughout treatment (22 weeks total)

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (5)

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

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

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

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

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

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

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

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

• Clinicians' experiences with the intervention delivered

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

Study Arms (2)

Intervention group

EXPERIMENTAL

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).

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

Treatment as usual (TAU) group

NO INTERVENTION

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.

Interventions

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

Also known as: Parenting intervention

Intervention group

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead
• Hospital Universitari Vall d'Hebron Research Institute: collaborator
• Parc Taulí Hospital Universitari: collaborator
• Fundació La Marató de TV3: collaborator

Study Sites (3)

Sant Joan de Deu

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Hospital Universitari Parc Taulí

Sabadell, Spain

Location

Related Publications (7)

• 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.

  PMID: 33879224 BACKGROUND

• 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.

  PMID: 29537331 BACKGROUND

• 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.

  PMID: 29774207 BACKGROUND

• 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.

  PMID: 26341300 BACKGROUND

• 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.

  PMID: 26375193 BACKGROUND

• 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.

  PMID: 31961490 BACKGROUND

• 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.

  PMID: 39033111 DERIVED

MeSH Terms

Conditions

Genetic Diseases, Inborn; Autistic Disorder; Psychological Well-Being

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Laia Villalta, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Anna Maria Cueto-González, MD

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

  STUDY CHAIR

• Carmen Manso, MD

  Parc Taulí Hospital Universitari

  STUDY CHAIR

• Mercedes Serrano, MD, PhD

  Hospital Sant Joan de Deu

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 9, 2023
• Study Start: March 14, 2023
• Primary Completion: September 16, 2024
• Study Completion: September 16, 2024
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)