Clinical trial NCT01445444: 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
Overall status: COMPLETED
Phase: NA
Conditions: Trichotillomania
Keywords: Habit Reversal Training
Hair Pulling
Children
Trich
cognitive behavioral therapy
TTM
psychotherapy
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2011-10-03
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Massachusetts General Hospital Hairpulling Scale (MGHHS)
timeFrame: 5 months
Secondary outcomes:
measure: NIMH-TIS
timeFrame: 5 months
Other outcomes:
Locations:
city: St. Petersburg
country: United States
facility: Rothman Center for Pediatric Neuropsychiatry
state: Florida
Study officials:
affiliation: University of South Florida
name: Adam B Lewin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Florida
name: Omar Rahman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: