Early parenting intervention for children with genetic abnormalities and mental health issues
Early Treatment for Children With Mental Health Problems and Genetic Abnormalities Through a Parenting Intervention (The GAP): A Pragmatic Randomized Controlled Trial
This study is testing a new online parenting program to see if it can help families with children who have genetic issues and mental health challenges.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 3 Years to 7 Years |
| Sex | All |
| Sponsor | Fundació Sant Joan de Déu Academic / other |
| Locations | 3 sites (Esplugues De Llobregat, Barcelona and 2 other locations) |
| Trial ID | NCT06125093 on ClinicalTrials.gov |
What this trial studies
The GAP study is a randomized controlled trial designed to evaluate the feasibility and effectiveness of the Incredible Years Autism Spectrum and Language Delays (IY-ASLD®) intervention for families with children facing developmental challenges due to genetic abnormalities. Families will be randomly assigned to either the intervention group, which will participate in 22 weekly online group sessions, or a control group that continues with their usual treatment. This multicentric trial aims to provide evidence-based treatment options for a vulnerable population that often lacks access to effective therapies. The findings will assist clinicians and policymakers in improving care pathways for these children and their families.
Who should consider this trial
Good fit: Ideal candidates include children aged 3 to 7 years with a diagnosis or high suspicion of a genetic abnormality and associated developmental or mental health challenges.
Not a fit: Patients who do not have a genetic abnormality or those who are outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the developmental outcomes for children with genetic abnormalities and improve the mental health of their parents.
How similar studies have performed: Previous studies have demonstrated the effectiveness of early parenting programs in improving developmental outcomes, suggesting that this approach may yield positive results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Esplugues De Llobregat, Barcelona and 2 other locations
- Sant Joan de Deu — Esplugues De Llobregat, Barcelona, Spain (Recruiting)
- Hospital Universitari Vall d'Hebron — Barcelona, Spain (Recruiting)
- Hospital Universitari Parc Taulí — Sabadell, Spain (Recruiting)
Study contacts
- Principal investigator: Laia Villalta, MD, PhD — Hospital Sant Joan de Déu. Fundació Privada per a la Recerca i la Docència Sant Joan de Déu
- Study coordinator: Laia Villalta, MD, PhD
- Email: laia.villalta@sjd.es
- Phone: +34936009751
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.