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Clinical Trials/NCT04860362
NCT04860362
Unknown
Not Applicable

Effectiveness of a Telehealth Group for Improving Peer Relationships for Adolescents With Neurofibromatosis Type 1

University of Wisconsin, Milwaukee1 site in 1 country30 target enrollmentJanuary 29, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neurofibromatosis 1
Sponsor
University of Wisconsin, Milwaukee
Enrollment
30
Locations
1
Primary Endpoint
Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Parent
Last Updated
5 years ago

Overview

Brief Summary

This is a pilot randomized control trial of the UCLA PEERS protocol delivered via Telehealth with teens with neurofibromatosis type 1 whose parents report that they have difficulty making and keeping friends.

Registry
clinicaltrials.gov
Start Date
January 29, 2021
End Date
August 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bonita P Klein-Tasman

Professor

University of Wisconsin, Milwaukee

Eligibility Criteria

Inclusion Criteria

  • Physician diagnosis of neurofibromatosis type 1
  • Age 12-17
  • Main language spoken in the home is English
  • Reliable internet access
  • Current functional impairment in peer relationships
  • Teen is interested and motivated to participate

Exclusion Criteria

  • Main language spoken in the home is not English
  • Cognitive or developmental difficulties that affect reading comprehension or understanding of treatment material
  • Significant behavioral concerns
  • Other comorbid medical conditions
  • Major surgery in past 6 months
  • Prior social skills group treatment within past 6 months
  • Prior participation in PEERS

Outcomes

Primary Outcomes

Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Parent

Time Frame: within four weeks of PEERS completion for treatment group

Amount of change from pre- to post-test differs from change in Wait List Control group

Test of Adolescent Social SKills (TASSK: Laugeson & Frankel, 2010)

Time Frame: within four weeks of PEERS completion

Change from pre- to post-test on total score (measures knowledge of the PEERS concepts)

Secondary Outcomes

  • Social Responsiveness Scale -2 (SRS-2; Constantino, 2005)(16 weeks following PEERS completion)
  • Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Teen(16 weeks following PEERS completion)

Study Sites (1)

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