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

Launched by FUNDACIÓ SANT JOAN DE DÉU · Nov 3, 2023

Keywords

ClinConnect Summary

The GAP study is a clinical trial designed to help families with young children who have genetic abnormalities and mental health challenges, such as language delays or social difficulties. The trial is testing a program called "Incredible Years Autism Spectrum and Language Delays" (IY-ASLD®), which will be delivered online through 22 weekly group sessions. Families will be randomly chosen to either participate in this new program or continue with their usual care. The goal is to see how well the program works and if it can provide better support for these children and their families.

To participate, children must be between 3 and 7 years old, have a possible genetic condition, and show signs of social challenges or developmental problems. Parents or caregivers should understand Spanish or Catalan and agree to join the study. It's important to note that children already diagnosed with Autism Spectrum Disorder or attending another parenting program cannot participate. This study aims to gather valuable information that can help doctors and policymakers provide better treatment options for these vulnerable children.

Gender

ALL

Eligibility 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 For children up to 5.11 years with withdrawn (defined as CBCL/1.5-5 scores above the borderline clinical range, T-score\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