NCT00917098

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2009

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2014

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

5.5 years

First QC Date

June 8, 2009

Last Update Submit

July 31, 2017

Conditions

Keywords

Behavior TherapySupportive CounselingChildAdolescentHair PullingCBT

Outcome Measures

Primary Outcomes (1)

  • Clinical Global Impression Scale (CGIS)

    Measured at baseline; Weeks 4, 8, 12, and 16; and 3- and 6-month follow-ups

Study Arms (2)

Behavior Therapy

EXPERIMENTAL

Participants will receive behavior therapy during Phases 1 and 2.

Behavioral: Behavior Therapy

Supportive Counseling

PLACEBO COMPARATOR

Participants will receive supportive counseling during Phase 1 and will not participate in Phase 2.

Behavioral: Supportive Counseling

Interventions

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

Behavior Therapy

Eight weekly sessions during Phase 1 of psychoeducation, support, and emotion management related to trichotillomania and other stressors

Supportive Counseling

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis or symptoms of trichotillomania
  • Presence of stable parent or guardian

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child and Adolescent OCD, Tic, Trichotillomania, and Anxiety Group (COTTAGe)

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

MeSH Terms

Conditions

Trichotillomania

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Obsessive-Compulsive DisorderAnxiety DisordersMental DisordersDisruptive, Impulse Control, and Conduct Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Martin E. Franklin, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2009

First Posted

June 10, 2009

Study Start

October 1, 2008

Primary Completion

March 26, 2014

Study Completion

March 26, 2014

Last Updated

August 1, 2017

Record last verified: 2017-07

Locations