Habit Reversal Training for Children and Adolescents With Trichotillomania

NCT01445444 | Completed

• 1 other identifier: HRT/TTM
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the current study is:

1. 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. 2.To explore factors that may relate to symptom severity, treatment outcome, and psychosocial impairment (e.g., specific symptom presence, co-morbidity, emotional regulation).

Conditions

Trichotillomania

Keywords

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

Outcome Measures

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).

  5 months

Secondary Outcomes (1)

• NIMH-TIS

  5 months

Study Arms (2)

HRT group

EXPERIMENTAL

This group receives habit reversal training immediately.

Behavioral: Habit Reversal Training

TAU group

ACTIVE COMPARATOR

This group receives treatment as usual for 8 weeks.

Behavioral: Habit Reversal Training

Interventions

Habit Reversal Training BEHAVIORAL

* 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

HRT group; TAU group

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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
• \) 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.

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

Rothman Center for Pediatric Neuropsychiatry

St. Petersburg, Florida, 33701, United States

Location

MeSH Terms

Conditions

Trichotillomania; Trichomonas Infections

Condition Hierarchy (Ancestors)

Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders; Protozoan Infections; Parasitic Diseases; Infections

Study Officials

• Adam B Lewin, Ph.D.

  University of South Florida

  PRINCIPAL INVESTIGATOR

• Omar Rahman, Ph.D.

  University of South Florida

  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: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: October 3, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: March 10, 2016

Record last verified: 2016-03

Locations

US (1)