Pilot Randomized Control Trial of Telehealth Group for Improving Peer Relationships (PEERS) in NF1

Not Applicable

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

• Registration Number: NCT04860362
• Lead Sponsor: University of Wisconsin, Milwaukee

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-29
• Status Verified: 2021-04
• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-04-23
• Last Update Submitted: 2021-04-23
• Study First Posted: 2021-04-26
• Last Update Posted: 2021-04-26
• Primary Completion: 2021-09
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment	PEERS	PEERS weekly sessions - parallel teens and parent/caregiver groups
Wait List Control	PEERS	Offered intervention at a later date

Primary Outcome Measures

Name	Time	Method
Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Parent	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)	within four weeks of PEERS completion	Change from pre- to post-test on total score (measures knowledge of the PEERS concepts)

Secondary Outcome Measures

Name	Time	Method
Social Responsiveness Scale -2 (SRS-2; Constantino, 2005)	16 weeks following PEERS completion	change from pre- to 16 week followup on Total SRS-2 completed by caregivers (measure of social impairment)
Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Teen	16 weeks following PEERS completion	Change from pre- to 16 week followup on teen self-report of social functioning

Trial Locations

Locations (1)

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