Pilot Randomized Control 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: Recruiting

Administrative data

• NCT number: NCT04860362
• Other study ID #: 21-039-UWM-b
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Neurofibroma
• Neurofibromatoses
• Neurofibromatosis 1
• Social Skills

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