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

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ClinicalTrials.gov Identifier: NCT04856514
Recruitment Status : Active, not recruiting
First Posted : April 23, 2021
Last Update Posted : April 27, 2021
Sponsor:
Collaborator:
NF Midwest
Information provided by (Responsible Party):
Bonita P Klein-Tasman, University of Wisconsin, Milwaukee

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.

Condition or disease Intervention/treatment Phase
Neurofibromatosis 1 Social Skills Behavioral: PEERS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of a Telehealth Group for Improving Peer Relationships for Adolescents With Neurofibromatosis Type 1
Actual Study Start Date : December 5, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021


Arm Intervention/treatment
Experimental: Treatment Group
Participation in 16 week telehealth administration of the PEERS protocol for teens (parallel teen and parent/caregiver groups)
Behavioral: PEERS
16 week telehealth intervention; parallel teen and parent/caregiver groups; 90 minutes each week.




Primary Outcome Measures :
  1. Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) [ Time Frame: within four weeks of PEERS completion ]
    Parental report of social skills (SSIS-SEL Total Score; Mean 100, SD 15; Higher scores mean stronger social functioning

  2. Test of Adolescent Social SKills (TASSK: Laugeson & Frankel, 2010) [ Time Frame: within four weeks of PEERS completion ]
    Questionnaire completed by teen participants; measures knowledge of the PEERS intervention concepts (raw total score; higher score means stronger functioning)


Secondary Outcome Measures :
  1. Social Responsiveness Scale (SRS; Constantino, 2005) [ Time Frame: within four weeks of PEERS completion ]
    Questionnaire completed by caregivers on social function and autism symptoms (SRS Total Score; Mean 50, SD 10; higher scores mean greater difficulties



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04856514


Locations
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United States, Wisconsin
University of Wisconsin-Milwaukee
Milwaukee, Wisconsin, United States, 53201
Sponsors and Collaborators
University of Wisconsin, Milwaukee
NF Midwest
Investigators
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Study Director: Danielle Glad, M.S. University of Wisconsin, Milwaukee
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Responsible Party: Bonita P Klein-Tasman, Professor, University of Wisconsin, Milwaukee
ClinicalTrials.gov Identifier: NCT04856514    
Other Study ID Numbers: 21-039-UWM-a
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified data will be available upon request to qualitied investigators.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Available following publication of the research findings
Access Criteria: Contact the PI (bklein@uwm.edu)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neurofibromatoses
Neurofibromatosis 1
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
Genetic Diseases, Inborn
Peripheral Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Neoplasms
Nervous System Neoplasms