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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rush University Medical Center
Study ID
NCT06139172
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
2 Years - 12 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Sep 15, 2023
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Functional Behavioral Training
  • Active Comparator: Positive Parenting Strategies-Treatment As Usual

Primary Outcome Measure

Clinical Global Impression [ Time Frame: TO (Baseline), T2 (Month 2), T4 (Month 4), T6 (Month 6) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Autism Assessment Research Treatment and Services (AARTS) Center at Rush University Medical CenterChicagoIllinois60612
Madison Nava, MS
[email protected]
312-563-3352

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By research site
Autism Assessment Research Treatment and Services (AARTS) Center at Rush University Medical Center· Chicago, IL

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