RecruitingNot ApplicableNCT06139172

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

Promoting Prosocial Behavior in Syndromic Intellectual and Developmental Disabilities


Sponsor

Rush University Medical Center

Enrollment

92 participants

Start Date

Sep 15, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 2 YearsMax Age: 12 Years

Inclusion Criteria8

  • 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 Criteria4

  • 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)

Interventions

BEHAVIORALFunctional 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.

OTHERPositive 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.


Locations(1)

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

Chicago, Illinois, United States

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NCT06139172


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