TrichotillomaniaNCT00917098
Examining Behavior Therapy for Trichotillomania in Children and Adolescents
A study testing Behavior Therapy and Supportive Counseling in people with Trichotillomania, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study will evaluate a treatment for trichotillomania, or compulsive hair pulling, in children and adolescents. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Trichotillomania
- What is being tested?
- Behavior Therapy and Supportive Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to 26 Mar 2014
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis or symptoms of trichotillomania
- Presence of stable parent or guardian
Who cannot join
- Presence of another primary or co-primary psychiatric disorder that requires initiation of different active current treatment
- Current use of psychotropic medication (participants may be able to stop taking medications to start with study)
Trial locations and contacts
1 site in 1 country.
United States1 site
Child and Adolescent OCD, Tic, Trichotillomania, and Anxiety Group (COTTAGe)
Philadelphia, Pennsylvania, 19104
About this study
Official title: Behavior Therapy for Pediatric Trichotillomania
This study will evaluate a treatment for trichotillomania, or compulsive hair pulling, in children and adolescents.
Read the detailed description
Trichotillomania (TTM) is a chronic impulse control disorder that causes people to pull out their own hair. TTM typically develops in late childhood or early adolescence. It has been suggested that, like with obsessive-compulsive disorder, early identification and treatment of TTM might prevent the disorder and other co-occurring disorders in adults. The researchers in this study have developed the first treatment for TTM to target children and adolescents. Preliminary trials of this treatment, called behavior therapy (BT), indicate efficacy. This study is a larger, more rigorous examination of whether BT can successfully treat children and adolescents with TTM.
Participation in this study will be divided into two phases, each lasting 8 weeks. Follow-up visits will occur 3 and 6 months after completing treatment. In Phase 1, participants will be randomly assigned to receive either BT or supportive counseling (SC) for their TTM. Both groups of participants will complete eight weekly study visits. Those receiving BT will be encouraged to identify situations in which hair pulling is likely to occur and use behavioral techniques to resist urges to pull their hair. BT will also involve self-monitoring and homework throughout the week. Those receiving SC will discuss ways to minimize interference of hair pulling with everyday life and receive education and emotional support from a study therapist-but will not be taught specific behavioral techniques. After 8 weeks, participants will be evaluated to determine whether treatment is helping them. If participants are receiving BT and showing reduction in symptoms, they will continue to Phase 2, which involves four maintenance sessions of BT over 8 weeks. If participants receiving BT are not responding to treatment, they will be given referrals to other services. Participants receiving SC will end their participation after 8 weeks, and those not responding to treatment will be offered BT.
Study assessments will be completed at baseline, after Phase 1, after Phase 2, and at 3- and 6-month follow-ups. These assessments will include a clinical interview, questionnaires about symptoms, and family assessment measures.
- Conditions
- Trichotillomania
- Being tested
- Behavior Therapy, Supportive Counseling
- Keywords
- Behavior Therapy, Supportive Counseling, Child, Adolescent, Hair Pulling, CBT
- Medical subject headings
- Trichotillomania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior TherapyBehavioural
Eight weekly sessions during Phase 1 and four sessions every other week during Phase 2; participants will work on implementing habit reversal techniques with psychoeducation, cognitive restructuring, and relaxation, if necessary
Supportive CounselingBehavioural
Eight weekly sessions during Phase 1 of psychoeducation, support, and emotion management related to trichotillomania and other stressors
| Study group | Role | What they receive |
|---|---|---|
| Behavior Therapy | Experimental | Participants will receive behavior therapy during Phases 1 and 2. Receives: Behavioral: Behavior Therapy |
| Supportive Counseling | Placebo comparator | Participants will receive supportive counseling during Phase 1 and will not participate in Phase 2. Receives: Behavioral: Supportive Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression Scale (CGIS)
Measured: Measured at baseline; Weeks 4, 8, 12, and 16; and 3- and 6-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startOct 2008
- Primary completion26 Mar 2014
- Study completion26 Mar 2014
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 PennsylvaniaThe 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Martin E. Franklin, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917098
- Sponsor's protocol ID
- R01MH077197
- Other IDs
- R01MH077197, DSIR 84-CTS
- Status last verified
- Jul 2017
- First submitted
- 8 Jun 2009
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavior Therapy for Pediatric Trichotillomania
- ClinicalTrials.gov ID
- NCT00917098
- Acronym / sponsor ID
- R01MH077197
- Conditions
- Trichotillomania
- Keywords
- Behavior Therapy, Supportive Counseling, Child, Adolescent, Hair Pulling, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2008
- Primary completion
- 26 Mar 2014 (actual)
- Study completion
- 26 Mar 2014 (actual)
- First posted
- 10 Jun 2009 (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.
This study will evaluate a treatment for trichotillomania, or compulsive hair pulling, in children and adolescents.
Detailed description
Trichotillomania (TTM) is a chronic impulse control disorder that causes people to pull out their own hair. TTM typically develops in late childhood or early adolescence. It has been suggested that, like with obsessive-compulsive disorder, early identification and treatment of TTM might prevent the disorder and other co-occurring disorders in adults. The researchers in this study have developed the first treatment for TTM to target children and adolescents. Preliminary trials of this treatment, called behavior therapy (BT), indicate efficacy. This study is a larger, more rigorous examination of whether BT can successfully treat children and adolescents with TTM.
Participation in this study will be divided into two phases, each lasting 8 weeks. Follow-up visits will occur 3 and 6 months after completing treatment. In Phase 1, participants will be randomly assigned to receive either BT or supportive counseling (SC) for their TTM. Both groups of participants will complete eight weekly study visits. Those receiving BT will be encouraged to identify situations in which hair pulling is likely to occur and use behavioral techniques to resist urges to pull their hair. BT will also involve self-monitoring and homework throughout the week. Those receiving SC will discuss ways to minimize interference of hair pulling with everyday life and receive education and emotional support from a study therapist-but will not be taught specific behavioral techniques. After 8 weeks, participants will be evaluated to determine whether treatment is helping them. If participants are receiving BT and showing reduction in symptoms, they will continue to Phase 2, which involves four maintenance sessions of BT over 8 weeks. If participants receiving BT are not responding to treatment, they will be given referrals to other services. Participants receiving SC will end their participation after 8 weeks, and those not responding to treatment will be offered BT.
Study assessments will be completed at baseline, after Phase 1, after Phase 2, and at 3- and 6-month follow-ups. These assessments will include a clinical interview, questionnaires about symptoms, and family assessment measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavior Therapy | Experimental | Behavioral: Behavior TherapyParticipants will receive behavior therapy during Phases 1 and 2. |
| Supportive Counseling | Placebo comparator | Behavioral: Supportive CounselingParticipants will receive supportive counseling during Phase 1 and will not participate in Phase 2. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosis or symptoms of trichotillomania
- Presence of stable parent or guardian
Key exclusion criteria (2 listed)
- Presence of another primary or co-primary psychiatric disorder that requires initiation of different active current treatment
- Current use of psychotropic medication (participants may be able to stop taking medications to start with 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 |
|---|---|---|
| Behavior TherapyEight weekly sessions during Phase 1 and four sessions every other week during Phase 2; participants will work on implementing habit reversal techniques with psychoeducation, cognitive restructuring, and relaxation, if necessary | Behavioural | Behavior Therapy |
| Supportive CounselingEight weekly sessions during Phase 1 of psychoeducation, support, and emotion management related to trichotillomania and other stressors | Behavioural | Supportive Counseling |
Primary outcome
Clinical Global Impression Scale (CGIS)
Time frame: Measured at baseline; Weeks 4, 8, 12, and 16; and 3- and 6-month follow-ups
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 1 Aug 2017.
- Click here for information about the University of Pennsylvania Child \& Adolescent OCD, Tic, Trich, \& Anxiety GroupLink provided by the sponsor.
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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.
Martin E. Franklin, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavior Therapy and Supportive Counseling in people with Trichotillomania, run by University of Pennsylvania 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 2 inclusion and 2 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 1 Aug 2017. 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. Some participants in this study may receive a placebo. 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?
Clinical Global Impression Scale (CGIS) (time frame: Measured at baseline; Weeks 4, 8, 12, and 16; and 3- and 6-month follow-ups). 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 1 Aug 2017.