Examining Behavior Therapy for Trichotillomania in Children and Adolescents
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00917098|
Recruitment Status : Completed
First Posted : June 10, 2009
Last Update Posted : August 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Trichotillomania||Behavioral: Behavior Therapy Behavioral: Supportive Counseling||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Behavior Therapy for Pediatric Trichotillomania|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||March 26, 2014|
|Actual Study Completion Date :||March 26, 2014|
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
- Clinical Global Impression Scale (CGIS) [ Time Frame: Measured at baseline; Weeks 4, 8, 12, and 16; and 3- and 6-month follow-ups ]
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): NCT00917098
|United States, Pennsylvania|
|Child and Adolescent OCD, Tic, Trichotillomania, and Anxiety Group (COTTAGe)|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Martin E. Franklin, PhD||University of Pennsylvania|