Back to resultsOpen Trial of Telehealth Group for Improving Peer Relationships (PEERS) in NF1
Primary Purpose
Neurofibromatosis 1, Social Skills
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PEERS
Sponsored by
About this trial
This is an interventional treatment trial for Neurofibromatosis 1
Eligibility Criteria
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
Sites / Locations
- University of Wisconsin-Milwaukee
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Group
Arm Description
Participation in 16 week telehealth administration of the PEERS protocol for teens (parallel teen and parent/caregiver groups)
Outcomes
Primary Outcome Measures
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
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)
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04856514
First Posted
April 19, 2021
Last Updated
April 22, 2021
Sponsor
University of Wisconsin, Milwaukee
Collaborators
NF Midwest
1. Study Identification
Unique Protocol Identification Number
NCT04856514
Brief Title
Open Trial of Telehealth Group for Improving Peer Relationships (PEERS) in NF1
Official Title
Effectiveness of a Telehealth Group for Improving Peer Relationships for Adolescents With Neurofibromatosis Type 1
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 5, 2020 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Wisconsin, Milwaukee
Collaborators
NF Midwest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurofibromatosis 1, Social Skills
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Participation in 16 week telehealth administration of the PEERS protocol for teens (parallel teen and parent/caregiver groups)
Intervention Type
Behavioral
Intervention Name(s)
PEERS
Intervention Description
16 week telehealth intervention; parallel teen and parent/caregiver groups; 90 minutes each week.
Primary Outcome Measure Information:
Title
Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017)
Description
Parental report of social skills (SSIS-SEL Total Score; Mean 100, SD 15; Higher scores mean stronger social functioning
Time Frame
within four weeks of PEERS completion
Title
Test of Adolescent Social SKills (TASSK: Laugeson & Frankel, 2010)
Description
Questionnaire completed by teen participants; measures knowledge of the PEERS intervention concepts (raw total score; higher score means stronger functioning)
Time Frame
within four weeks of PEERS completion
Secondary Outcome Measure Information:
Title
Social Responsiveness Scale (SRS; Constantino, 2005)
Description
Questionnaire completed by caregivers on social function and autism symptoms (SRS Total Score; Mean 50, SD 10; higher scores mean greater difficulties
Time Frame
within four weeks of PEERS completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle Glad, M.S.
Organizational Affiliation
University of Wisconsin, Milwaukee
Official's Role
Study Director
Facility Information:
Facility Name
University of Wisconsin-Milwaukee
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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)
Learn more about this trial
Open Trial of Telehealth Group for Improving Peer Relationships (PEERS) in NF1
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