Promoting Prosocial Behavior in Syndromic Intellectual and Developmental Disabilities
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 79
- Locations
- 1
- Primary Endpoint
- Clinical Global Impression
Study Overview
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 strategies in individuals with syndromic intellectual and developmental disorders.
Participants will be asked to complete virtual study assessments at intake and then on a monthly basis for the duration of 3-6 months. In addition, participants will attend weekly or biweekly virtual intervention visits with a study therapist.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 2 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Positive Parenting Strategies-Treatment As Usual
Intervention: Positive Parenting Strategies-Treatment as Usual (Other)
Functional Behavioral Training
Intervention: Functional Behavioral Training (FBT) (Behavioral)
Outcomes
Primary Outcomes
Clinical Global Impression
Time Frame: TO (Baseline), T2 (Month 2), T4 (Month 4), T6 (Month 6)
Overall functioning will be measured using the Clinical Global Impression for Severity (CGI-S) and Improvement (CGl-I). GCI-S will be recorded at Baseline with CGI-S and CGI-I collected at all determined visits. The CGI provides a rating of the child's global functioning, taking into account all available information (e.g., child's symptoms, behavior, functioning). The CGI-S and CGl-I will be completed by a blinded independent evaluator.
Secondary Outcomes
- Parent Target Problems (PTP) Inventory(TO (Baseline), T2 (Month 2), T4 (Month 4), T6 (Month 6))
- Adverse Event Monitoring(TO (Baseline), T1 (Month 1), T2 (Month 2), T3 (Month 3), T4 (Month 4), T5 (Month 5), T6 (Month 6))
- Aberrant Behavior Checklist, Second Edition (ABC-2)(TO (Baseline), T2 (Month 2), T4 (Month 4), T6 (Month 6))
Investigators
Latha Soorya
Associate Professor | Department of Psychiatry & Behavioral Sciences Director | AARTS Center
Rush University Medical Center