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NCT04856514 Clinical Trial

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

Neurofibromatosis 1 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04856514
Other study ID # 21-039-UWM-a
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 5, 2020
Est. completion date July 2021

Study information
Verified date April 2021
Source University of Wisconsin, Milwaukee
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 8
Est. completion date July 2021
Est. primary completion date July 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 17 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• PEERS
16 week telehealth intervention; parallel teen and parent/caregiver groups; 90 minutes each week.

Locations
Country Name City State
United States University of Wisconsin-Milwaukee Milwaukee Wisconsin

Sponsors (2)
Lead Sponsor Collaborator
University of Wisconsin, Milwaukee NF Midwest

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) 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
Primary Test of Adolescent Social SKills (TASSK: Laugeson & Frankel, 2010) 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 Social Responsiveness Scale (SRS; Constantino, 2005) 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
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