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
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Neurofibroma
• Neurofibromatoses
• Neurofibromatosis 1
• Social Skills

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