Examining Behavior Therapy for Trichotillomania in Children and Adolescents

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Pennsylvania.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00917098
First received: June 8, 2009
Last updated: February 14, 2012
Last verified: February 2012
  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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00917098

Contacts
Contact: Julie Harrison, BA 215-746-3327 julha@upenn.edu

Locations
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   
Sponsors and Collaborators
University of Pennsylvania
Investigators
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 July 20, 2014