NCT06125093Completed
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
Source: ClinicalTrials.gov · Last updated 10 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 53 (actual)
- First submitted
- 23 Oct 2023
- Start date
- 14 Mar 2023
- Primary completion date
- 16 Sept 2024
- Lead sponsor
- Fundació Sant Joan de Déu
- Diseases
- Autism
- NCT number
- NCT06125093
What you commit to
- Study type: Interventional
- Participants enrolled: 53
- From 14 Mar 2023 to the primary completion date, 16 Sept 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Children diagnosed with an Autism Spectrum Disorder
- Children scoring above diagnostic cut-off for Autism or Autism Spectrum Disorder in the ADOS-2.
Other
- Attending another structured parenting program
- Children in the care of their local authority
Who the study is looking for
- 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- For children up to 5.11 years with withdrawn (defined as CBCL/1.5-5 scores above the borderline clinical range, T-score\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
Age in the registry: 3 years to 7 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Sant Joan de Deu Coordinator of this site? Confirm its status | Esplugues de Llobregat | Spain | Unknown status |
| Hospital Universitari Parc Taulí Coordinator of this site? Confirm its status | Sabadell | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.