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

NCT04860362 | Unknown

• 1 other identifier: 21-039-UWM-b
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neurofibromatosis 1; Social Skills

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Social Responsiveness Scale -2 (SRS-2; Constantino, 2005)

  within 4 weeks following PEERS completion

• Social Responsiveness Scale -2 (SRS-2; Constantino, 2005)

  16 weeks following PEERS completion

• Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Teen

  within 4 weeks of PEERS completion

• Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Teen

  16 weeks following PEERS completion

Other Outcomes (2)

• Peds QL (Varni et al, 2002) Parent

  within 4 weeks of PEERS completion

• Peds QL (Varni et al, 2002) Teen

  within 4 weeks of PEERS completion

Study Arms (2)

Treatment

EXPERIMENTAL

PEERS weekly sessions - parallel teens and parent/caregiver groups

Behavioral: PEERS

Wait List Control

OTHER

Offered intervention at a later date

Behavioral: PEERS

Interventions

PEERS BEHAVIORAL

Structured social skills curriculum including didactics, behavioral rehearsal, parent coaching, and parent coaching support.

Also known as: Program for the Education and Enrichment of Relational Skills

Treatment; Wait List Control

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 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

Sponsors & Collaborators

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

Study Sites (1)

University of Wisconsin-Milwaukee

Milwaukee, Wisconsin, 53201, United States

RECRUITING

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

• Bonnie Klein-Tasman, PhD

  University of Wisconsin, Milwaukee

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bonita P Klein-Tasman, PhD

CONTACT

414-229-3060; bklein@uwm.edu

Danielle Glad

CONTACT

414-229-2586; dmglad@uwm.edu

Study Design

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

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 26, 2021
• Study Start: January 29, 2021
• Primary Completion: September 1, 2021
• Study Completion: August 1, 2022
• Last Updated: April 26, 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 study.
• Access Criteria: Contact the PI (bklein@uwm.edu)

Locations

US (1)