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

NCT06139172 | Recruiting DMC

• 1 other identifier: 21012004
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Telomeric 22Q13 Monosomy Syndrome; Tuberous Sclerosis; Hamartoma Syndrome, Multiple; Fragile X Syndrome; Angelman Syndrome; Rett Syndrome; Chromosome 15Q, Partial Deletion; Creatine Deficiency, X-linked

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Parent Target Problems (PTP) Inventory

  TO (Baseline), T2 (Month 2), T4 (Month 4), T6 (Month 6)

• Aberrant Behavior Checklist, Second Edition (ABC-2)

  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)

Study Arms (2)

Functional Behavioral Training

EXPERIMENTAL

Behavioral: Functional Behavioral Training (FBT)

Positive Parenting Strategies-Treatment As Usual

ACTIVE COMPARATOR

Other: Positive Parenting Strategies-Treatment as Usual

Interventions

Functional Behavioral Training (FBT) BEHAVIORAL

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.

Functional Behavioral Training

Positive Parenting Strategies-Treatment as Usual OTHER

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.

Positive Parenting Strategies-Treatment As Usual

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rush University Medical Center: lead
• Emory University: collaborator

Study Sites (1)

Autism Assessment Research Treatment and Services (AARTS) Center at Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Telomeric 22q13 Monosomy Syndrome; Tuberous Sclerosis; Hamartoma Syndrome, Multiple; Fragile X Syndrome; Angelman Syndrome; Rett Syndrome; Chromosome 15q, partial deletion; Creatine deficiency, X-linked

Condition Hierarchy (Ancestors)

Hamartoma; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Nervous System Diseases; Neurocutaneous Syndromes; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Sex Chromosome Disorders; Chromosome Disorders; Genetic Diseases, X-Linked; Movement Disorders; Central Nervous System Diseases; Abnormalities, Multiple; Imprinting Disorders

Central Study Contacts

Latha Soorya, PhD

CONTACT

312-942-3767; Latha_Soorya@rush.edu

Allison Wainer, PhD

CONTACT

Allison_Wainer@rush.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor | Department of Psychiatry & Behavioral Sciences Director | AARTS Center

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: September 15, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)