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临床试验/NCT04860362
NCT04860362Unknown不适用

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

University of Wisconsin, Milwaukee1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年1月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Parent

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Treatment

Experimental

PEERS weekly sessions - parallel teens and parent/caregiver groups

干预措施: PEERS (Behavioral)

Wait List Control

Other

Offered intervention at a later date

干预措施: PEERS (Behavioral)

结局指标

主要结局

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

时间窗: within four weeks of PEERS completion for treatment group

Amount of change from pre- to post-test differs from change in Wait List Control group

Test of Adolescent Social SKills (TASSK: Laugeson & Frankel, 2010)

时间窗: within four weeks of PEERS completion

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

时间窗: within 4 weeks of PEERS completion

Change from pre- to post-test on SSIS-SEL parent Total Standard Score (measures social functioning)

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

时间窗: 16 weeks following PEERS completion

Change from pre- to 16 week followup on total score

次要结局

  • Social Responsiveness Scale -2 (SRS-2; Constantino, 2005)(16 weeks following PEERS completion)
  • Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Teen(16 weeks following PEERS completion)
  • Social Responsiveness Scale -2 (SRS-2; Constantino, 2005)(within 4 weeks following PEERS completion)
  • Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Teen(within 4 weeks of PEERS completion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bonita P Klein-Tasman

Professor

University of Wisconsin, Milwaukee

研究点 (1)

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