Web intervention for parents of children with genetic syndromes
Promoting Prosocial Behavior in Syndromic Intellectual and Developmental Disabilities
This study is testing a new online therapy program to help parents of young children with genetic syndromes learn better ways to manage their kids' challenging behaviors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 2 Years to 12 Years |
| Sex | All |
| Sponsor | Rush University Medical Center Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06139172 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a telehealth functional behavioral therapy designed to enhance communication and behavioral strategies for children with syndromic intellectual and developmental disorders. Participants, aged 2-12 years, will undergo virtual assessments and receive weekly or biweekly coaching sessions with a therapist over a period of 3-6 months. The intervention focuses on parent-implemented strategies to address disruptive behaviors associated with various genetic syndromes.
Who should consider this trial
Good fit: Ideal candidates are children aged 2-12 years with a diagnosed genetic syndrome and documented developmental delays or intellectual disabilities.
Not a fit: Patients with high levels of aggression or those requiring more intensive care than what can be provided remotely may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve communication and behavioral outcomes for children with genetic syndromes and their families.
How similar studies have performed: Other studies have shown promise in using telehealth interventions for behavioral therapy, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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)
Where this trial is running
Chicago, Illinois
- Autism Assessment Research Treatment and Services (AARTS) Center at Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Latha Soorya, PhD
- Email: Latha_Soorya@rush.edu
- Phone: 312-942-3767
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.