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Habit Reversal Training for Children and Adolescents With Trichotillomania

Primary Purpose

Trichotillomania

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Habit Reversal Training

About this trial

This is an interventional treatment trial for Trichotillomania focused on measuring Habit Reversal Training, Hair Pulling, Children, Trich, cognitive behavioral therapy, TTM, psychotherapy

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Rothman Center for Pediatric Neuropsychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HRT group

TAU group

Arm Description

This group receives habit reversal training immediately.

This group receives treatment as usual for 8 weeks.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01445444

First Posted

September 29, 2011

Last Updated

March 9, 2016

Sponsor

University of South Florida

1. Study Identification

Unique Protocol Identification Number

NCT01445444

Brief Title

Habit Reversal Training for Children and Adolescents With Trichotillomania

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of South Florida

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the current study is: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trichotillomania

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HRT group

Arm Type

Experimental

Arm Description

This group receives habit reversal training immediately.

Arm Title

TAU group

Arm Type

Active Comparator

Arm Description

This group receives treatment as usual for 8 weeks.

Intervention Type

Behavioral

Intervention Name(s)

Habit Reversal Training

Other Intervention Name(s)

Trichotillomania, Hair pulling, TTM

Intervention Description

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.

Primary Outcome Measure Information:

Title

Massachusetts General Hospital Hairpulling Scale (MGHHS)

Description

Time Frame

5 months

Secondary Outcome Measure Information:

Title

NIMH-TIS

Description

Time Frame

5 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adam B Lewin, Ph.D.

Organizational Affiliation

University of South Florida

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Omar Rahman, Ph.D.

Organizational Affiliation

University of South Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rothman Center for Pediatric Neuropsychiatry

City

St. Petersburg

State/Province

Florida

ZIP/Postal Code

33701

Country

United States

12. IPD Sharing Statement

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Habit Reversal Training for Children and Adolescents With Trichotillomania

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