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

Study Overview
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Brief Summary
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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.

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

Conditions
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Neurofibromatosis 1, Social Skills

Intervention / Treatment
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* Behavioral: PEERS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |