Habit Reversal Training for Children and Adolescents With Trichotillomania

NCT ID: NCT01445444

Last Updated: 2016-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2016-03-31

Brief 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).

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.

Conditions

Trichotillomania

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HRT group

This group receives habit reversal training immediately.

Group Type: EXPERIMENTAL

Habit Reversal Training

Intervention Type: 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.

TAU group

This group receives treatment as usual for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Habit Reversal Training

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Trichotillomania; Hair pulling; TTM

Eligibility 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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Adam Lewin

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adam B Lewin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Omar Rahman, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

Rothman Center for Pediatric Neuropsychiatry

St. Petersburg, Florida, United States

Countries

United States

Related Links

http://health.usf.edu/medicine/pediatrics/rothman/index.htm

Rothman Center for Pediatric Neuropsychiatry

Other Identifiers

HRT/TTM

Identifier Type: -

Identifier Source: org_study_id