Status:
COMPLETED
Study of an Early Parenting Intervention for Children With Genetic Abnormalities and Mental Health Problems
Lead Sponsor:
Fundació Sant Joan de Déu
Collaborating Sponsors:
Hospital Universitari Vall d'Hebron Research Institute
Parc Taulí Hospital Universitari
Conditions:
Genetic Syndrome
Language Development
Eligibility:
All Genders
3-7 years
Phase:
NA
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...
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 develo...
Eligibility Criteria
Inclusion
- 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- For children up to 5.11 years with withdrawn (defined as CBCL/1.5-5 scores above the borderline clinical range, T-score\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
Exclusion
- 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
Key Trial Info
Start Date :
March 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2024
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT06125093
Start Date
March 14 2023
End Date
September 16 2024
Last Update
December 10 2025
Active Locations (3)
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1
Sant Joan de Deu
Esplugues de Llobregat, Barcelona, Spain, 08950
2
Hospital Universitari Vall d'Hebron
Barcelona, Spain
3
Hospital Universitari Parc Taulí
Sabadell, Spain