Recruiting

Telehealth Group

Sponsor:

University of Wisconsin, Milwaukee

Code:

NCT04860362

Conditions

Neurofibromatosis 1

Social Skills

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Accepted

Interventions

PEERS

Study Details

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.

Conditions

Neurofibromatosis 1

Social Skills

Study ID

NCT04860362

Start date

Jan 29, 2021

Status verified date

Apr, 2021

Completion date

Aug, 2022

Anticipated

Primary completion date

Sep, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

PEERS weekly sessions - parallel teens and parent/caregiver groups

other: Wait List Control

Offered intervention at a later date

Interventions

PEERS

Structured social skills curriculum including didactics, behavioral rehearsal, parent coaching, and parent coaching support.

Primary outcome measure

  • Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Parent [ Time Frame: within 4 weeks of PEERS completion ]
  • Test of Adolescent Social SKills (TASSK: Laugeson & Frankel, 2010) [ Time Frame: within four weeks of PEERS completion ]
  • Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Parent [ Time Frame: 16 weeks following PEERS completion ]
  • Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Parent [ Time Frame: within four weeks of PEERS completion for treatment group ]

Central Contacts and Locations

Central contacts

Bonita P Klein-Tasman, PhD

414-229-3060bklein@uwm.edu

Danielle Glad

414-229-2586dmglad@uwm.edu

Locations

University of Wisconsin-Milwaukee

Recruiting

Milwaukee, Wisconsin, United States, 53201

Contacts

Bonita Klein-Tasman, PhD

414-229-3060bklein@uwm.edu

More Information

Sponsor

University of Wisconsin, Milwaukee

Last update posted

Apr 26, 2021

Last verified

Apr, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Wisconsin, Milwaukee on 2021-04-26.