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Habit Reversal Training for Children and Adolescents With Trichotillomania

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of South Florida
Sponsor:
Information provided by (Responsible Party):
Adam Lewin, University of South Florida
ClinicalTrials.gov Identifier:
NCT01445444
First received: September 29, 2011
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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).

Condition Intervention
Trichotillomania
Behavioral: Habit Reversal Training

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: Habit Reversal Training for Children and Adolescents With Trichotillomania: A Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Massachusetts General Hospital Hairpulling Scale (MGHHS) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • NIMH-TIS [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: September 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HRT group
This group receives habit reversal training immediately.
Behavioral: Habit 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.
Other Names:
  • Habit Reversal Training
  • Trichotillomania
  • Hair pulling
  • TTM
Active Comparator: TAU group
This group receives treatment as usual for 8 weeks.
Behavioral: Habit 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.
Other Names:
  • Habit Reversal Training
  • Trichotillomania
  • Hair pulling
  • TTM

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.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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.
  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: NCT01445444

Contacts
Contact: Amanda Collier, BA 727-767-8230 acollie2@health.usf.edu
Contact: Omar Rahman, PhD 727-767-8230 rothmanctr@health.usf.edu

Locations
United States, Florida
Rothman Center for Pediatric Neuropsychiatry Recruiting
St. Petersburg, Florida, United States, 33701
Contact: Amanda Collier, BA    727-767-8230    acollie2@health.edu   
Contact: Morgan King, BA    727-767-8230    mking1@health.usf.edu   
Principal Investigator: Adam Lewin, PhD         
Principal Investigator: Omar Rahman, PhD         
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Adam B Lewin, Ph.D. University of South Florida
Principal Investigator: Omar Rahman, Ph.D. University of South Florida
  More Information

Additional Information:
No publications provided

Responsible Party: Adam Lewin, Assistant Professor, University of South Florida
ClinicalTrials.gov Identifier: NCT01445444     History of Changes
Other Study ID Numbers: HRT/TTM
Study First Received: September 29, 2011
Last Updated: March 24, 2014
Health Authority: United States: Federal Government

Keywords provided by University of South Florida:
Habit Reversal Training
Hair Pulling
Children
Trich
cognitive behavioral therapy
TTM
psychotherapy

Additional relevant MeSH terms:
Trichotillomania
Impulse Control Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 19, 2014