Pilot Randomized Control Trial of Telehealth Group for Improving Peer Relationships (PEERS) in NF1

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

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.

Study Overview

• Status: Recruiting
• Conditions: Social Skills; Neurofibromatosis 1
• Intervention / Treatment: Behavioral: PEERS

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bonita P Klein-Tasman, PhD; Phone Number: 414-229-3060; Email: bklein@uwm.edu
• Study Contact Backup: Name: Danielle Glad; Phone Number: 414-229-2586; Email: dmglad@uwm.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53201
      • Recruiting
      • University of Wisconsin-Milwaukee
      • Contact: Bonita Klein-Tasman, PhD; Phone Number: 414-229-3060; Email: bklein@uwm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; PEERS weekly sessions - parallel teens and parent/caregiver groups	Behavioral: PEERS; Structured social skills curriculum including didactics, behavioral rehearsal, parent coaching, and parent coaching support.; Other Names: Program for the Education and Enrichment of Relational Skills
Other: Wait List Control; Offered intervention at a later date	Behavioral: PEERS; Structured social skills curriculum including didactics, behavioral rehearsal, parent coaching, and parent coaching support.; Other Names: Program for the Education and Enrichment of Relational Skills

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peds QL (Varni et al, 2002) Parent	Change from pre- to post-test in parental ratings of QoL	within 4 weeks of PEERS completion
Peds QL (Varni et al, 2002) Teen	Change from pre- to post-test in teen ratings of QoL	within 4 weeks of PEERS completion

Collaborators and Investigators

• Sponsor: University of Wisconsin, Milwaukee
• Collaborators: NF Midwest; NF Northeast
• Investigators: Principal Investigator: Bonnie Klein-Tasman, PhD, University of Wisconsin, Milwaukee

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2021
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: April 23, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 23, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Genetic Diseases, Inborn; Neuromuscular Diseases; Neurodegenerative Diseases; Neoplasms, Nerve Tissue; Peripheral Nervous System Diseases; Nervous System Neoplasms; Heredodegenerative Disorders, Nervous System; Neoplastic Syndromes, Hereditary; Nerve Sheath Neoplasms; Neurocutaneous Syndromes; Peripheral Nervous System Neoplasms; Neurofibromatoses; Neurofibromatosis 1; Neurofibroma
• Other Study ID Numbers: 21-039-UWM-b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Deidentified data will be available upon request to qualified investigators.
• IPD Sharing Time Frame: Available following publication of the research study.
• IPD Sharing Access Criteria: Contact the PI (bklein@uwm.edu)
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No