Open Trial of Telehealth Group for Improving Peer Relationships (PEERS) in NF1

NCT04856514 | Unknown

• 1 other identifier: 21-039-UWM-a
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurofibromatosis 1; Social Skills

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Social Responsiveness Scale (SRS; Constantino, 2005)

  within four weeks of PEERS completion

Study Arms (1)

Treatment Group

EXPERIMENTAL

Participation in 16 week telehealth administration of the PEERS protocol for teens (parallel teen and parent/caregiver groups)

Behavioral: PEERS

Interventions

PEERS BEHAVIORAL

16 week telehealth intervention; parallel teen and parent/caregiver groups; 90 minutes each week.

Treatment Group

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Milwaukee: lead
• NF Midwest: collaborator

Study Sites (1)

University of Wisconsin-Milwaukee

Milwaukee, Wisconsin, 53201, United States

Location

MeSH Terms

Conditions

Neurofibromatosis 1; Social Skills

Condition Hierarchy (Ancestors)

Neurofibromatoses; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Social Behavior; Behavior

Study Officials

• Danielle Glad, M.S.

  University of Wisconsin, Milwaukee

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 23, 2021
• Study Start: December 5, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Available following publication of the research findings
• Access Criteria: Contact the PI (bklein@uwm.edu)

Locations

US (1)