Early Treatment for Children With Mental Health Problems and Genetic Abnormalities Through a Parenting Intervention (The GAP): A Pragmatic Randomized Controlled Trial
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.
• 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• For children up to 5.11 years with withdrawn (defined as CBCL/1.5-5 scores above the borderline clinical range, T-score\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