NCT06125093

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Fundació Sant Joan de Déu · Academic / Other
• Sex: All
• Age: 3 Years – 7 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-14
• Primary completion: 2024-09-16
• Completion: 2024-09-16
• First posted: 2023-11-09
• Last updated: 2025-12-10

Locations

3 sites across 1 country: Spain