Web Intervention for Parents of Youth With Genetic Syndromes (WINGS)

Promoting Prosocial Behavior in Syndromic Intellectual and Developmental Disabilities

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 Overview

• Status: Recruiting
• Conditions: Tuberous Sclerosis; Fragile X Syndrome; Rett Syndrome; Hamartoma Syndrome, Multiple; Angelman Syndrome; Creatine Deficiency, X-linked; Telomeric 22Q13 Monosomy Syndrome; Chromosome 15Q, Partial Deletion
• Intervention / Treatment: Behavioral: Functional Behavioral Training (FBT); Other: Positive Parenting Strategies-Treatment as Usual

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Latha Soorya, PhD; Phone Number: 312-942-3767; Email: Latha_Soorya@rush.edu
• Study Contact Backup: Name: Allison Wainer, PhD; Email: Allison_Wainer@rush.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Autism Assessment Research Treatment and Services (AARTS) Center at Rush University Medical Center
      • Contact: Madison Nava, MS; Phone Number: 312-563-3352; Email: Madison_T_Nava@rush.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Functional Behavioral Training	Behavioral: Functional Behavioral Training (FBT); Function-based treatment (FBT) is a term for behavioral intervention approaches that use objective and systematic data collection to identify the cause of challenging behavior and teach a more prosocial replacement behavior. FBTslDD incorporates standard elements of FBT protocols with adaptations made specifically to support application to the syndromic IDD population. FBTslDD will include the following steps: (1) Syndromic IDD screening; (2) Stimulus preference assessment; (3) Indirect and descriptive assessments; (4) Screening for automatic function; (5) Functional analysis (FA); and (6) FBT intervention phase. If steps 1 - 5 determine a participant's challenging behavior serves a social function, Functional Communication Training (FCT) will be administered. If steps 1 - 5 determine a participant's challenging behavior serves an automatic function Competing Stimulus Treatment (CST) will be administered.
Active Comparator: Positive Parenting Strategies-Treatment As Usual	Other: Positive Parenting Strategies-Treatment as Usual; Using the Planned Adaptation approach, to identify proactive adaptations seeking to improve the fit of FBTsIDD with the unique needs of the syndromic IDD population. Triangulating mixed methods data from systematic video observations, questionnaires, and qualitative interviews, then the Framework for Reporting Adaptations and Modifications-Expanded24 (FRAME) will be used to develop a rich understanding of these and any additional adaptations made to the intervention when delivered by non-specialist providers within medical hubs serving syndromic IDD populations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression	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.	TO (Baseline), T2 (Month 2), T4 (Month 4), T6 (Month 6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event Monitoring	Adverse events will be measured at each time point, and the log used in this study will be based on adverse event logs that have already been developed for other ongoing NIH trials in our center. The adverse event log will include data on any adverse events, the onset date, intensity of event(s), relationship to study (i.e., unrelated through definitely related), end date, outcome, regulatory action taken (if necessary), and whether treatment was required.	TO (Baseline), T1 (Month 1), T2 (Month 2), T3 (Month 3), T4 (Month 4), T5 (Month 5), T6 (Month 6)
Parent Target Problems (PTP) Inventory	The Parent Target Problems is a blinded rating provided by an independent evaluator and based on a caregiver interview (30-minutes at baseline; 10- to 15-minutes at follow-visits throughout the study). The independent evaluator will use the PTP interview to record the caregivers' estimate of the frequency of problematic behaviors. From this description, the independent evaluator (blind to treatment assignment) will generate a brief narrative describing the child's problem behaviors and their impact on daily functioning. The evaluator will read this back to the caregiver to provide corrections and/or add any pertinent missing information. This process will continue until the narrative represents an accurate description per caregiver report. Change on the chief concerns determined from interviews are then rated on a 9-point scale (1=normalized, 5=unchanged, 9=disastrous). The PTP has been used to measure outcomes in behavioral intervention trials.	TO (Baseline), T2 (Month 2), T4 (Month 4), T6 (Month 6)
Aberrant Behavior Checklist, Second Edition (ABC-2)	The Aberrant Behavior Checklist, Second Edition (ABC-2) is a widely-used symptom checklist (completed by caregivers) that measures problematic behavior across five domain subscales: irritability, social withdrawal, stereotypic behavior, hyperactivity/noncompliance, inappropriate speech. Changes in raw scores across each subscale will be tracked against caregiver reports described in the PTP.	TO (Baseline), T2 (Month 2), T4 (Month 4), T6 (Month 6)

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: Emory University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Imprinting Disorders; Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Genetic Diseases, Inborn; Neurobehavioral Manifestations; Neurodegenerative Diseases; Congenital Abnormalities; Movement Disorders; Abnormalities, Multiple; Heredodegenerative Disorders, Nervous System; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Intellectual Disability; Genetic Diseases, X-Linked; Hamartoma; Neoplasms, Multiple Primary; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Sex Chromosome Disorders; Chromosome Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; X-Linked Intellectual Disability; Rett Syndrome; Tuberous Sclerosis; Fragile X Syndrome; Angelman Syndrome; Hamartoma Syndrome, Multiple; Creatine deficiency, X-linked; Telomeric 22q13 Monosomy Syndrome; Chromosome 15q, partial deletion
• Other Study ID Numbers: 21012004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No