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

April 22, 2021 updated by: Bonita P Klein-Tasman, University of Wisconsin, Milwaukee

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53201
        • University of Wisconsin-Milwaukee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
Participation in 16 week telehealth administration of the PEERS protocol for teens (parallel teen and parent/caregiver groups)
Behavioral: PEERS
16 week telehealth intervention; parallel teen and parent/caregiver groups; 90 minutes each week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017)
Time Frame: 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
within four weeks of PEERS completion
Test of Adolescent Social SKills (TASSK: Laugeson & Frankel, 2010)
Time Frame: 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)
within four weeks of PEERS completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social Responsiveness Scale (SRS; Constantino, 2005)
Time Frame: 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
within four weeks of PEERS completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Milwaukee

Collaborators

NF Midwest

Investigators

  • Study Director: Danielle Glad, M.S., University of Wisconsin, Milwaukee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2020

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

April 19, 2021

First Submitted That Met QC Criteria

April 19, 2021

First Posted (Actual)

April 23, 2021

Study Record Updates

Last Update Posted (Actual)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-039-UWM-a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data will be available upon request to qualitied investigators.

IPD Sharing Time Frame

Available following publication of the research findings

IPD Sharing Access Criteria

Contact the PI (bklein@uwm.edu)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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