TrichotillomaniaNCT01445444
Habit Reversal Training for Children and Adolescents With Trichotillomania
A study testing Habit Reversal Training in people with Trichotillomania, run by University of South Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Trichotillomania
- What is being tested?
- Habit Reversal Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Outpatient children between the ages of 7-17 years.
- Meets DSM-IV criteria for a primary diagnosis of TTM
- English speaking
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Center for Pediatric Neuropsychiatry
St. Petersburg, Florida, 33701
About this study
Official title: Habit Reversal Training for Children and Adolescents With Trichotillomania: A Controlled Trial
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).
Read the 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
- Being tested
- Habit Reversal Training
- Keywords
- Habit Reversal Training, Hair Pulling, Children, Trich, cognitive behavioral therapy, TTM, psychotherapy
- Medical subject headings
- Trichotillomania, Trichomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Habit Reversal TrainingBehavioural
Also called Trichotillomania, Hair pulling, TTM
- 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.
| Study group | Role | What they receive |
|---|---|---|
| HRT group | Experimental | This group receives habit reversal training immediately. Receives: Behavioral: Habit Reversal Training |
| TAU group | Active comparator | This group receives treatment as usual for 8 weeks. Receives: Behavioral: Habit Reversal Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 months
Secondary outcomes (1)
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrichotillomaniaStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Lewin, University of South Florida
- Investigators
- Adam B Lewin, Ph.D., Principal investigator, University of South FloridaOmar Rahman, Ph.D., Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445444
- Sponsor's protocol ID
- HRT/TTM
- Status last verified
- Mar 2016
- First submitted
- 29 Sep 2011
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Habit Reversal Training for Children and Adolescents With Trichotillomania: A Controlled Trial
- ClinicalTrials.gov ID
- NCT01445444
- Acronym / sponsor ID
- HRT/TTM
- Conditions
- Trichotillomania
- Keywords
- Habit Reversal Training, Hair Pulling, Children, Trich, cognitive behavioral therapy, TTM, psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 3 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRT group | Experimental | Behavioral: Habit Reversal TrainingThis group receives habit reversal training immediately. |
| TAU group | Active comparator | Behavioral: Habit Reversal TrainingThis group receives treatment as usual for 8 weeks. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Outpatient children between the ages of 7-17 years.
- Meets DSM-IV criteria for a primary diagnosis of TTM
- English speaking
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Habit Reversal TrainingAlso: Trichotillomania, Hair pulling, TTM* 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. | Behavioural | HRT group, TAU group |
Primary outcome
Massachusetts General Hospital Hairpulling Scale (MGHHS)
Time frame: 5 months
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).
1 secondary outcome
NIMH-TIS
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam B Lewin, Ph.D. principal investigator
University of South Florida
Omar Rahman, Ph.D. principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Habit Reversal Training in people with Trichotillomania, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Massachusetts General Hospital Hairpulling Scale (MGHHS) (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2016.