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CompletedNCT01445444Updated Mar 10, 2016

Habit Reversal Training for Children and Adolescents With Trichotillomania

An interventional study of Habit Reversal Training in Trichotillomania, sponsored by University of South Florida. Completed at 1 site in United States. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2016-03-10.

Sponsored by University of South Florida · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
7 Years to 17 Years
Sex
All
01

Study summary

The purpose of the current study is:

  1. To evaluate the effectiveness of a habit reversal training (HRT) approach for children ages 7 to 17 years of age inclusive with a diagnosis of trichotillomania.
  2. To explore factors that may relate to symptom severity, treatment outcome, and psychosocial impairment (e.g., specific symptom presence, co-morbidity, emotional regulation).
Read the detailed description

The purpose of this research study is to further investigate how well Habit Reversal Training (HRT) works to reduce hair-pulling symptoms in children and adolescents with trichotillomania (TTM).

All children will have the option to receive 8 weekly HRT sessions. Half of all children will be chosen at random to receive these sessions immediately following the pre-assessment and the remaining half will receive them after eight weeks (TAU condition). These sessions will focus developing skills for managing TTM and to decrease hair pulling. Such skills may include teaching your child to replace hair-pulling with another behavior. In the TAU condition, participants will seek the treatment in the community, with the option of receiving HRT treatment sessions at the end of the study.

Participants in both groups will undergo four assessments in total (1) Pre-Assessment; (2) Post-treatment Assessment; (3) One-month Follow-up; (4)Three-month Follow-up. These assessments will involve several interviews that ask about different psychological symptoms that your child experiences such as sadness, anxiety, and TTM.

02

Conditions studied

  • Trichotillomania

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Keywords

  • Habit Reversal Training
  • Hair Pulling
  • Children
  • Trich
  • cognitive behavioral therapy
  • TTM
  • psychotherapy
03

In context

Trichotillomania

44 studies on the registry are indexed under Trichotillomania; 7 are open to participants now.

This study's planned enrollment of 50 is above the median of 38 across 42 interventional studies indexed under Trichotillomania.

Browse Trichotillomania studies →

Lead sponsor

University of South Florida is the lead sponsor of 333 studies on the registry; 63 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Outpatient children between the ages of 7-17 years.
  • Meets DSM-IV criteria for a primary diagnosis of TTM
  • English speaking

Exclusion criteria

Exclusion Criteria:

  • Lifetime DSM-IV bipolar, schizophrenia, or schizoaffective disorder, or substance abuse in past 6 months.
  • A diagnosis of an autism spectrum disorders, mental retardation, or conduct disorder
    1. Current clinically significant suicidal intent, or 2) individuals who have engaged in suicidal behaviors within 6 months
  • Receiving concurrent psychotherapy or behavioral interventions. Families will have the option of discontinuing such services to enroll in the study. Those randomized to treatment as usual (TAU) will be able to continue or initiate psychosocial interventions whereas those randomized to HRT will not receive other interventions concurrent with HRT.
  • Any change in established psychotropic medication (e.g., antidepressants, anxioloytics) within 4 weeks before study enrollment, any change in antipsychotics within 3 weeks prior to the screening assessment, any change in fluoxetine or atamoxetine within 6 weeks of study enrollment, and any change in alpha-2 agonists or stimulants within 1 week of study enrollment. Those randomized to TAU may make medication changes following randomization, including starting a medication; those randomized to HRT will remain stable on medications during the study.
  • Unwillingness of parents to make the commitment to accompany their child for multiple study visits, unwillingness to take part in randomization, inability to attend weekly sessions as therapist availability allows, inability to attend assessment visits.
  • Presence of a significant and/or unstable medical illness which might lead to hospitalization during the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    HRT group

    This group receives habit reversal training immediately.

    Behavioral: Habit Reversal Training

  • Active comparator
    TAU group

    This group receives treatment as usual for 8 weeks.

    Behavioral: Habit Reversal Training

Interventions

  • BehavioralHabit Reversal Training

    * 8 weekly therapy sessions lasting 50 minutes based on the protocol outlined by Woods (2001). * The overall focus of treatment is to provide patients with tools to help them manage and reduce hair-pulling. * components: * Session 1. (a) to develop an understanding of the subject's hair-pulling through an initial interview; and (b) to establish a protocol for ongoing assessment. * Session 2. implement habit reversal, including awareness training, competing response training, and social support. * Sessions 3-8. For subjects with a single hair-pulling site, Session 3 will review and practice HRT procedures and name solutions to problems that may have arisen. For those with multiple hair-pulling sites, treatment will be reviewed for the first site in the hierarchy.

    Also known as: Trichotillomania, Hair pulling, TTM

06

What researchers measure

Primary outcomes

  1. Massachusetts General Hospital Hairpulling Scale (MGHHS)

    This measure assesses the number of hair-pulling urges, the intensity of the urges, the ability of the patients to distract themselves from the urge to pull their hair, the number of hair-pulling incidents, attempts to resist hair-pulling, the ability to resist hair-pulling, and feeling uncomfortable about hair-pulling. Individual items are rated for severity from 0 (no symptoms) to 4 (extreme symptoms).

    Time frame: 5 months

Secondary outcomes

  1. NIMH-TIS

    The NIMH-TIS is a clinician rated scale (0-10 rating) measuring overall impairment produced by the time spent pulling or concealing damage, ability to control pulling, severity of alopecia, interference, and incapacitation caused by the pulling.

    Time frame: 5 months

07

Study locations

1 site
  • Rothman Center for Pediatric Neuropsychiatry
    St. Petersburg, Florida 33701, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01445444
Lead sponsor
University of South Florida
Responsible party
Adam Lewin (Associate Professor, University of South Florida) — Principal investigator
First posted
Oct 3, 2011
Start date
Sep 2011
Primary completion
Dec 2015
Completion
Mar 2016
Last update
Mar 10, 2016

Study contacts

Adam B Lewin, Ph.D.
principal investigator · University of South Florida
Omar Rahman, Ph.D.
principal investigator · University of South Florida

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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