Study of an Early Parenting Intervention for Children With Genetic Abnormalities and Mental Healt… (NCT06125093) | Clinical Trial Compass
CompletedNot Applicable
Study of an Early Parenting Intervention for Children With Genetic Abnormalities and Mental Health Problems
Spain53 participantsStarted 2023-03-14
Plain-language 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 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.
Who can participate
Age range3 Years – 7 Years
SexALL
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Inclusion criteria
✓. 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 For children up to 5.11 years with withdrawn (defined as CBCL/1.5-5 scores above the borderline clinical range, T-score\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 criteria
✕. Children diagnosed with an Autism Spectrum Disorder
What they're measuring
1
Percentage of parents engaging with and finishing the program
Timeframe: Attendance sheet completed weekly throughout treatment (22 weeks total)
2
Compliance and satisfaction throughout the study (Autism Program Parent Weekly Evaluation)
Timeframe: Questionnaire administered to the intervention group weekly throughout treatment (22 weeks total)
3
Parents' acceptability and satisfaction with the program (evaluated with the Autism Program Parent Final Satisfaction Questionnaire)
Timeframe: Administered to the intervention group at treatment completion (approximately 22 weeks after baseline)
4
Parents' overall experiences with the program (evaluated with individual interviews)
Timeframe: Interviews to the participants of the intervention group at treatment completion (approximately 22 weeks after baseline)