Open Trial of Telehealth Group for Improving Peer Relationships (PEERS) in NF1

Not Applicable

• Conditions: Neurofibromatosis 1; Social Skills
• Interventions: Behavioral: PEERS

• Registration Number: NCT04856514
• Lead Sponsor: University of Wisconsin, Milwaukee

Brief Summary

This is an open 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-05
• Status Verified: 2021-04
• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-04-19
• Last Update Submitted: 2021-04-22
• Study First Posted: 2021-04-23
• Last Update Posted: 2021-04-27
• Primary Completion: 2021-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

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 delays 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	PEERS	Participation in 16 week telehealth administration of the PEERS protocol for teens (parallel teen and parent/caregiver groups)

Primary Outcome Measures

Name	Time	Method
Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017)	within four weeks of PEERS completion	Parental report of social skills (SSIS-SEL Total Score; Mean 100, SD 15; Higher scores mean stronger social functioning
Test of Adolescent Social SKills (TASSK: Laugeson & Frankel, 2010)	within four weeks of PEERS completion	Questionnaire completed by teen participants; measures knowledge of the PEERS intervention concepts (raw total score; higher score means stronger functioning)

Secondary Outcome Measures

Name	Time	Method
Social Responsiveness Scale (SRS; Constantino, 2005)	within four weeks of PEERS completion	Questionnaire completed by caregivers on social function and autism symptoms (SRS Total Score; Mean 50, SD 10; higher scores mean greater difficulties

Trial Locations

Locations (1)

University of Wisconsin-Milwaukee; 🇺🇸 Milwaukee, Wisconsin, United States