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

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

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute

  collaborator OTHER

• Parc Taulí Hospital Universitari

  collaborator OTHER

• Fundació La Marató de TV3

  collaborator OTHER

• Fundació Sant Joan de Déu

  lead OTHER

Principal Investigators

• Laia Villalta, MD, PhD · Hospital Sant Joan de Déu. Fundació Privada per a la Recerca i la Docència Sant Joan de Déu

• Anna Maria Cueto-González, MD · Hospital Universitari Vall d'Hebron. Vall d'Hebron Institut de Recerca

• Carmen Manso, MD · Parc Taulí Hospital Universitari

• Mercedes Serrano, MD, PhD · Hospital Sant Joan de Deu

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

7 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-14

Primary Completion

2024-09-16

Completion

2024-09-16

Countries

• Spain

Study Locations