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Behavioural Intervention
Virtual Therapy for Developmental Disabilities
N/A
Recruiting
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Existing genetic syndrome based on clinical or genetic diagnosis and confirmed by medical records
Caregiver who is able to consent in English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up to (baseline), t1 (month 1), t2 (month 2), t3 (month 3), t4 (month 4), t5 (month 5), t6 (month 6)
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a virtual therapy program to help people with intellectual and developmental disorders better communicate and manage their behavior. Participants will do assessments and have weekly or biweekly virtual visits with a therapist.
Who is the study for?
This trial is for children aged 2-12 with certain genetic syndromes like Fragile X or Rett Syndrome, who have moderate to profound intellectual disabilities and behavioral challenges. They need a caregiver who speaks English and can attend weekly online sessions. Kids unstable medically or psychiatrically, recently changing treatments, or lacking tech access for telehealth are excluded.
What is being tested?
The study tests an adapted telehealth functional behavioral therapy (FBTsIDD) aimed at improving communication and behavior in kids with developmental disorders. It involves virtual assessments and regular online sessions with therapists over 3-6 months.
What are the potential side effects?
Since the intervention involves behavioral training and parenting strategies rather than medication, there may not be physical side effects. However, participants might experience frustration or stress during the learning process of new behaviors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a confirmed genetic syndrome.
Select...
My caregiver can understand and consent in English.
Select...
I am between 2 and 12 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ to (baseline), t1 (month 1), t2 (month 2), t3 (month 3), t4 (month 4), t5 (month 5), t6 (month 6)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~to (baseline), t1 (month 1), t2 (month 2), t3 (month 3), t4 (month 4), t5 (month 5), t6 (month 6)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical Global Impression
Secondary study objectives
Aberrant Behavior Checklist, Second Edition (ABC-2)
Adverse Event Monitoring
Parent Target Problems (PTP) Inventory
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Functional Behavioral TrainingExperimental Treatment1 Intervention
Group II: Positive Parenting Strategies-Treatment As UsualActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
436 Previous Clinical Trials
249,272 Total Patients Enrolled
Emory UniversityOTHER
1,700 Previous Clinical Trials
2,604,506 Total Patients Enrolled
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