Examining Behavior Therapy for Trichotillomania in Children and Adolescents

Behavior Therapy for Pediatric Trichotillomania

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

Study Overview

• Status: Completed
• Conditions: Trichotillomania
• Intervention / Treatment: Behavioral: Behavior Therapy; Behavioral: Supportive Counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Child and Adolescent OCD, Tic, Trichotillomania, and Anxiety Group (COTTAGe)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical Global Impression Scale (CGIS)	Measured at baseline; Weeks 4, 8, 12, and 16; and 3- and 6-month follow-ups

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Martin E. Franklin, PhD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): March 26, 2014
• Study Completion (Actual): March 26, 2014

Study Registration Dates

• First Submitted: June 8, 2009
• First Submitted That Met QC Criteria: June 8, 2009
• First Posted (Estimate): June 10, 2009

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 31, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Adolescent; Child; CBT; Behavior Therapy; Hair Pulling; Supportive Counseling
• Additional Relevant MeSH Terms: Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders; Trichotillomania
• Other Study ID Numbers: R01MH077197 (U.S. NIH Grant/Contract); DSIR 84-CTS (Division of Services and Intervention Research)