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临床试验/NCT00917098
NCT00917098已完成不适用

Behavior Therapy for Pediatric Trichotillomania

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2008年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
2
主要终点
Clinical Global Impression Scale (CGIS)

研究概览

简要总结

This study will evaluate a treatment for trichotillomania, or compulsive hair pulling, in children and adolescents.

详细描述

Trichotillomania (TTM) is a chronic impulse control disorder that causes people to pull out their own hair. TTM typically develops in late childhood or early adolescence. It has been suggested that, like with obsessive-compulsive disorder, early identification and treatment of TTM might prevent the disorder and other co-occurring disorders in adults. The researchers in this study have developed the first treatment for TTM to target children and adolescents. Preliminary trials of this treatment, called behavior therapy (BT), indicate efficacy. This study is a larger, more rigorous examination of whether BT can successfully treat children and adolescents with TTM.

Participation in this study will be divided into two phases, each lasting 8 weeks. Follow-up visits will occur 3 and 6 months after completing treatment. In Phase 1, participants will be randomly assigned to receive either BT or supportive counseling (SC) for their TTM. Both groups of participants will complete eight weekly study visits. Those receiving BT will be encouraged to identify situations in which hair pulling is likely to occur and use behavioral techniques to resist urges to pull their hair. BT will also involve self-monitoring and homework throughout the week. Those receiving SC will discuss ways to minimize interference of hair pulling with everyday life and receive education and emotional support from a study therapist-but will not be taught specific behavioral techniques. After 8 weeks, participants will be evaluated to determine whether treatment is helping them. If participants are receiving BT and showing reduction in symptoms, they will continue to Phase 2, which involves four maintenance sessions of BT over 8 weeks. If participants receiving BT are not responding to treatment, they will be given referrals to other services. Participants receiving SC will end their participation after 8 weeks, and those not responding to treatment will be offered BT.

Study assessments will be completed at baseline, after Phase 1, after Phase 2, and at 3- and 6-month follow-ups. These assessments will include a clinical interview, questionnaires about symptoms, and family assessment measures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Diagnosis or symptoms of trichotillomania
  • Presence of stable parent or guardian

排除标准

  • Presence of another primary or co-primary psychiatric disorder that requires initiation of different active current treatment
  • Current use of psychotropic medication (participants may be able to stop taking medications to start with study)

研究组 & 干预措施

Behavior Therapy

Experimental

Participants will receive behavior therapy during Phases 1 and 2.

干预措施: Behavior Therapy (Behavioral)

Supportive Counseling

Placebo Comparator

Participants will receive supportive counseling during Phase 1 and will not participate in Phase 2.

干预措施: Supportive Counseling (Behavioral)

结局指标

主要结局

Clinical Global Impression Scale (CGIS)

时间窗: Measured at baseline; Weeks 4, 8, 12, and 16; and 3- and 6-month follow-ups

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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