Clinical trial NCT00917098: Examining Behavior Therapy for Trichotillomania in Children and Adolescents
Official title: Behavior Therapy for Pediatric Trichotillomania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trichotillomania
Keywords: Behavior Therapy
Supportive Counseling
Child
Adolescent
Hair Pulling
CBT
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-06-10
Enrollment: 61
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Clinical Global Impression Scale (CGIS)
timeFrame: Measured at baseline; Weeks 4, 8, 12, and 16; and 3- and 6-month follow-ups
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Child and Adolescent OCD, Tic, Trichotillomania, and Anxiety Group (COTTAGe)
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Martin E. Franklin, PhD
role: PRINCIPAL_INVESTIGATOR
References: