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

Primary Purpose

Neurofibromatosis 1, Social Skills

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PEERS
Sponsored by
University of Wisconsin, Milwaukee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurofibromatosis 1

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Wisconsin-MilwaukeeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Treatment

Wait List Control

Arm Description

PEERS weekly sessions - parallel teens and parent/caregiver groups

Offered intervention at a later date

Outcomes

Primary Outcome Measures

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)
Test of Adolescent Social SKills (TASSK: Laugeson & Frankel, 2010)
Change from pre- to post-test on total score (measures knowledge of the PEERS concepts)
Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Parent
Change from pre- to 16 week followup on total score
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

Secondary Outcome Measures

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)
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)
Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Teen
Change from pre- to post-test on teen self-report of social functioning
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

Full Information

First Posted
April 19, 2021
Last Updated
April 23, 2021
Sponsor
University of Wisconsin, Milwaukee
Collaborators
NF Midwest, NF Northeast
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1. Study Identification

Unique Protocol Identification Number
NCT04860362
Brief Title
Pilot Randomized Control Trial of Telehealth Group for Improving Peer Relationships (PEERS) in NF1
Official Title
Effectiveness of a Telehealth Group for Improving Peer Relationships for Adolescents With Neurofibromatosis Type 1
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 29, 2021 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Wisconsin, Milwaukee
Collaborators
NF Midwest, NF Northeast

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurofibromatosis 1, Social Skills

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
PEERS weekly sessions - parallel teens and parent/caregiver groups
Arm Title
Wait List Control
Arm Type
Other
Arm Description
Offered intervention at a later date
Intervention Type
Behavioral
Intervention Name(s)
PEERS
Other Intervention Name(s)
Program for the Education and Enrichment of Relational Skills
Intervention Description
Structured social skills curriculum including didactics, behavioral rehearsal, parent coaching, and parent coaching support.
Primary Outcome Measure Information:
Title
Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Parent
Description
Change from pre- to post-test on SSIS-SEL parent Total Standard Score (measures social functioning)
Time Frame
within 4 weeks of PEERS completion
Title
Test of Adolescent Social SKills (TASSK: Laugeson & Frankel, 2010)
Description
Change from pre- to post-test on total score (measures knowledge of the PEERS concepts)
Time Frame
within four weeks of PEERS completion
Title
Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Parent
Description
Change from pre- to 16 week followup on total score
Time Frame
16 weeks following PEERS completion
Title
Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Parent
Description
Amount of change from pre- to post-test differs from change in Wait List Control group
Time Frame
within four weeks of PEERS completion for treatment group
Secondary Outcome Measure Information:
Title
Social Responsiveness Scale -2 (SRS-2; Constantino, 2005)
Description
change from pre- to post-test on Total SRS-2 completed by caregivers (measure of social impairment)
Time Frame
within 4 weeks following PEERS completion
Title
Social Responsiveness Scale -2 (SRS-2; Constantino, 2005)
Description
change from pre- to 16 week followup on Total SRS-2 completed by caregivers (measure of social impairment)
Time Frame
16 weeks following PEERS completion
Title
Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Teen
Description
Change from pre- to post-test on teen self-report of social functioning
Time Frame
within 4 weeks of PEERS completion
Title
Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Teen
Description
Change from pre- to 16 week followup on teen self-report of social functioning
Time Frame
16 weeks following PEERS completion
Other Pre-specified Outcome Measures:
Title
Peds QL (Varni et al, 2002) Parent
Description
Change from pre- to post-test in parental ratings of QoL
Time Frame
within 4 weeks of PEERS completion
Title
Peds QL (Varni et al, 2002) Teen
Description
Change from pre- to post-test in teen ratings of QoL
Time Frame
within 4 weeks of PEERS completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bonita P Klein-Tasman, PhD
Phone
414-229-3060
Email
bklein@uwm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Glad
Phone
414-229-2586
Email
dmglad@uwm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonnie Klein-Tasman, PhD
Organizational Affiliation
University of Wisconsin, Milwaukee
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin-Milwaukee
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bonita Klein-Tasman, PhD
Phone
414-229-3060
Email
bklein@uwm.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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)

Learn more about this trial

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

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