Examining Behavior Therapy for Trichotillomania in Children and Adolescents
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Purpose
This study will evaluate a treatment for trichotillomania, or compulsive hair pulling, in children and adolescents.
| Condition | Intervention |
|---|---|
|
Trichotillomania |
Behavioral: Behavior Therapy Behavioral: Supportive Counseling |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Behavior Therapy for Pediatric Trichotillomania |
- Clinical Global Impression Scale (CGIS) [ Time Frame: Measured at baseline; Weeks 4, 8, 12, and 16; and 3- and 6-month follow-ups ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Behavior Therapy
Participants will receive behavior therapy during Phases 1 and 2.
|
Behavioral: Behavior Therapy
Eight weekly sessions during Phase 1 and four sessions every other week during Phase 2; participants will work on implementing habit reversal techniques with psychoeducation, cognitive restructuring, and relaxation, if necessary
|
|
Placebo Comparator: Supportive Counseling
Participants will receive supportive counseling during Phase 1 and will not participate in Phase 2.
|
Behavioral: Supportive Counseling
Eight weekly sessions during Phase 1 of psychoeducation, support, and emotion management related to trichotillomania and other stressors
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 10 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis or symptoms of trichotillomania
- Presence of stable parent or guardian
Exclusion Criteria:
- 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)
Contacts and Locations| Contact: Julie Harrison, BA | 215-746-3327 | julha@upenn.edu |
| United States, Pennsylvania | |
| Child and Adolescent OCD, Tic, Trichotillomania, and Anxiety Group (COTTAGe) | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Julie Harrison, BA 215-746-3327 julha@upenn.edu | |
| Principal Investigator: | Martin E. Franklin, PhD | University of Pennsylvania |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00917098 History of Changes |
| Other Study ID Numbers: | R01 MH077197, R01MH077197, DSIR 84-CTS |
| Study First Received: | June 8, 2009 |
| Last Updated: | February 14, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Pennsylvania:
|
Behavior Therapy Supportive Counseling Child |
Adolescent Hair Pulling CBT |
Additional relevant MeSH terms:
|
Trichotillomania Impulse Control Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013