Habit Reversal Training for Children and Adolescents With Trichotillomania

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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

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.
    


Study Type

Interventional


Primary Outcome

Massachusetts General Hospital Hairpulling Scale (MGHHS)

Secondary Outcome

 NIMH-TIS

Condition

Trichotillomania

Intervention

Habit Reversal Training

Study Arms / Comparison Groups

 HRT group
Description:  This group receives habit reversal training immediately.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

50

Start Date

September 2011

Completion Date

March 2016

Primary Completion Date

December 2015

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.
      

Gender

All

Ages

7 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

Adam B Lewin, Ph.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01445444

Organization ID

HRT/TTM


Responsible Party

Principal Investigator

Study Sponsor

University of South Florida


Study Sponsor

Adam B Lewin, Ph.D., Principal Investigator, University of South Florida


Verification Date

March 2016