Examining Behavior Therapy for Trichotillomania in Children and Adolescents
Primary Purpose
Trichotillomania
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavior Therapy
Supportive Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Trichotillomania focused on measuring Behavior Therapy, Supportive Counseling, Child, Adolescent, Hair Pulling, CBT
Eligibility Criteria
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)
Sites / Locations
- Child and Adolescent OCD, Tic, Trichotillomania, and Anxiety Group (COTTAGe)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Behavior Therapy
Supportive Counseling
Arm Description
Participants will receive behavior therapy during Phases 1 and 2.
Participants will receive supportive counseling during Phase 1 and will not participate in Phase 2.
Outcomes
Primary Outcome Measures
Clinical Global Impression Scale (CGIS)
Secondary Outcome Measures
Full Information
NCT ID
NCT00917098
First Posted
June 8, 2009
Last Updated
July 31, 2017
Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00917098
Brief Title
Examining Behavior Therapy for Trichotillomania in Children and Adolescents
Official Title
Behavior Therapy for Pediatric Trichotillomania
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 26, 2014 (Actual)
Study Completion Date
March 26, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will evaluate a treatment for trichotillomania, or compulsive hair pulling, in children and adolescents.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichotillomania
Keywords
Behavior Therapy, Supportive Counseling, Child, Adolescent, Hair Pulling, CBT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavior Therapy
Arm Type
Experimental
Arm Description
Participants will receive behavior therapy during Phases 1 and 2.
Arm Title
Supportive Counseling
Arm Type
Placebo Comparator
Arm Description
Participants will receive supportive counseling during Phase 1 and will not participate in Phase 2.
Intervention Type
Behavioral
Intervention Name(s)
Behavior Therapy
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Supportive Counseling
Intervention Description
Eight weekly sessions during Phase 1 of psychoeducation, support, and emotion management related to trichotillomania and other stressors
Primary Outcome Measure Information:
Title
Clinical Global Impression Scale (CGIS)
Time Frame
Measured at baseline; Weeks 4, 8, 12, and 16; and 3- and 6-month follow-ups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin E. Franklin, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child and Adolescent OCD, Tic, Trichotillomania, and Anxiety Group (COTTAGe)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.med.upenn.edu/cottage/
Description
Click here for information about the University of Pennsylvania Child & Adolescent OCD, Tic, Trich, & Anxiety Group
Learn more about this trial
Examining Behavior Therapy for Trichotillomania in Children and Adolescents
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