Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT06125093
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 For children up to 5.11 years with withdrawn (defined as CBCL/1.5-5 scores above the borderline clinical range, T-score\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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
7 Years
Study:
NCT06125093
Study Brief:
Protocol Section:
NCT06125093