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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04860362
Other study ID # 21-039-UWM-b
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 29, 2021
Est. completion date August 2022

Study information

Verified date April 2021
Source University of Wisconsin, Milwaukee
Contact Bonita P Klein-Tasman, PhD
Phone 414-229-3060
Email bklein@uwm.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date August 2022
Est. primary completion date September 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 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


Intervention

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

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
University of Wisconsin, Milwaukee NF Midwest, NF Northeast

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Peds QL (Varni et al, 2002) Parent Change from pre- to post-test in parental ratings of QoL within 4 weeks of PEERS completion
Other Peds QL (Varni et al, 2002) Teen Change from pre- to post-test in teen ratings of QoL within 4 weeks of PEERS completion
Primary Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Parent Change from pre- to post-test on SSIS-SEL parent Total Standard Score (measures social functioning) within 4 weeks of PEERS completion
Primary Test of Adolescent Social SKills (TASSK: Laugeson & Frankel, 2010) Change from pre- to post-test on total score (measures knowledge of the PEERS concepts) within four weeks of PEERS completion
Primary Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Parent Change from pre- to 16 week followup on total score 16 weeks following PEERS completion
Primary Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Parent Amount of change from pre- to post-test differs from change in Wait List Control group within four weeks of PEERS completion for treatment group
Secondary Social Responsiveness Scale -2 (SRS-2; Constantino, 2005) change from pre- to post-test on Total SRS-2 completed by caregivers (measure of social impairment) within 4 weeks following PEERS completion
Secondary Social Responsiveness Scale -2 (SRS-2; Constantino, 2005) change from pre- to 16 week followup on Total SRS-2 completed by caregivers (measure of social impairment) 16 weeks following PEERS completion
Secondary Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Teen Change from pre- to post-test on teen self-report of social functioning within 4 weeks of PEERS completion
Secondary Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Teen Change from pre- to 16 week followup on teen self-report of social functioning 16 weeks following PEERS completion
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