Status:
RECRUITING
Web Intervention for Parents of Youth With Genetic Syndromes (WINGS)
Lead Sponsor:
Rush University Medical Center
Collaborating Sponsors:
Emory University
Conditions:
Telomeric 22Q13 Monosomy Syndrome
Tuberous Sclerosis
Eligibility:
All Genders
2-12 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the effectiveness of an adapted, telehealth functional behavioral therapy (FBTsIDD) specifically focused on promoting appropriate communication and behavioral ...
Eligibility Criteria
Inclusion
- Age(s) 2-12 years old at time of enrollment
- Existing genetic syndrome based on clinical or genetic diagnosis and confirmed by medical records
- Documented diagnosis of global developmental delay (GDD) or intellectual disability (ID)
- estimated ID in all ranges
- Disruptive behavior challenges determined to be clinically appropriate for remote, parent-implemented coaching based on clinician determination of acuity of problem behaviors
- Caregiver who is able to consent in English.
- Parent/caregiver available for weekly intervention sessions
- Stable psychosocial and psychiatric treatments 3 months prior to baseline visit.
Exclusion
- High levels of aggression that mitigate remote or outpatient treatment as defined by clinician judgement and/or ABC Irritability scores above 20 (i.e., higher level of care needed than provided by study procedures)
- Medical or psychiatric instability that may limit study participation
- Meaningful change in medication or psychosocial interventions 3 months prior to baseline visit
- Limitations in technology access that may hinder participation in remote trial (e.g., declining support provided by study participation)
Key Trial Info
Start Date :
September 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT06139172
Start Date
September 15 2023
End Date
December 1 2026
Last Update
January 31 2025
Active Locations (1)
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1
Autism Assessment Research Treatment and Services (AARTS) Center at Rush University Medical Center
Chicago, Illinois, United States, 60612