Obsessive-Compulsive DisorderPhase 3NCT00000386
Behavior Therapy for Children and Adolescents With Obsessive-Compulsive Disorder (OCD)
A Phase 3 study testing Exposure and Response Prevention, Family Treatment Program and Relaxation Training in people with Obsessive-Compulsive Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
The purpose of this study is to evaluate a behavioral treatment program for children and adolescents with OCD and their families. Exposure and Response Prevention (ERP) behavior therapy, in which the patient is gradually exposed to the object or situation that causes anxiety and is taught to refrain from responding in… Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Exposure and Response Prevention, Family Treatment Program and Relaxation Training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Dec 1998to Nov 2003
- Phase
- Phase 3
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -
- Patients must have:
- Obsessive-compulsive disorder for which he/she has not received medication.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univ. of California / Los Angeles / Neuropsychiatric Inst.
Los Angeles, California, 90024-1759
About this study
Official title: Behavior Therapy for Childhood OCD
The purpose of this study is to evaluate a behavioral treatment program for children and adolescents with OCD and their families. Exposure and Response Prevention (ERP) behavior therapy, in which the patient is gradually exposed to the object or situation that causes anxiety and is taught to refrain from responding in a compulsive manner, is combined with family counseling (Family Treatment Program). This treatment will be compared to Relaxation Training (RT).
OCD is a long-term, often disabling disorder that can cause significant family disruption. ERP is a promising treatment for children with OCD, and it is thought that family participation (through the Family Treatment Program) may be a helpful addition. RT is a common treatment for anxiety.
Read more
Patients are assigned randomly (like tossing a coin) to receive either the ERP/Family Treatment Program or RT. Both treatments will be delivered over 12 90-minute outpatient sessions to youngsters and their families. All participants (patients and family members) will be assessed for treatment response each month during treatment, after treatment is finished, and then at 2 follow-up visits over the following 6 months.
A child/adolescent may be eligible for this study if he/she:
Has obsessive-compulsive disorder (OCD), is medication-free, and is 8 to 17 years old.
Read the detailed description
To evaluate a standardized multicomponent cognitive behavioral treatment program for child and adolescent obsessive-compulsive disorder (OCD). The treatment program consists of individual Exposure and Response Prevention (ERP) for the OCD child plus a concurrent family intervention designed to reduce OCD-related family conflict, facilitate family disengagement from the affected child's OCD behavior, and rebuild normal family interaction patterns. The ERP/Family Treatment Program is compared with Relaxation Training (RT).
OCD is a chronic, often disabling disorder in childhood that has been associated with increased rates of parental psychopathology and significant disruptions in family relationships and functioning. Preliminary studies suggest that ERP is an effective treatment for children with OCD although no controlled trials to this effect have been published. RT was selected as the comparison treatment because of its credibility as an anxiety treatment and familiarity to potential subjects. RT has been used as a comparison condition for at least 2 randomized controlled ERP trials for adult OCD and shown to be ineffective in treating this disorder. Although it has long been hypothesized that family participation in treatment may be helpful, this is the first controlled study incorporating a systematic manualized family treatment component.
Participants are randomly assigned to receive either the combined ERP/Family Treatment Program (n=56) or RT (n=24). Both treatments are delivered over 12 90-minute outpatient sessions according to detailed treatment manuals.Youth and families undergo comprehensive and systematic, including behavioral, assessments by blind clinical evaluators at baseline, monthly during treatment, post-treatment and 2 follow-up evaluations over 6 months. Treatment outcome is examined in multimodal fashion and across multiple functional domains with a special emphasis on family contextual variables. The impact of baseline functioning, including family context, and initial change over time on treatment outcome is also systematically evaluated.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Exposure and Response Prevention, Family Treatment Program, Relaxation Training, Behavior therapy, Family Counseling
- Keywords
- Adolescence, Child, Comparative Study, Family, Female, Human, Male, Obsessive-Compulsive Disorder, Relaxation Techniques, Obsessive-Compulsive Disorder -- *therapy
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure and Response PreventionBehavioural
Family Treatment ProgramBehavioural
Relaxation TrainingBehavioural
Behavior therapyBehavioural
Family CounselingBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 1999 (estimated)
- Study startDec 1998
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Investigators
- John C. Piacentini, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000386
- Sponsor's protocol ID
- R01MH058459
- Other IDs
- DSIR CT-S
- Status last verified
- Feb 2008
- First submitted
- 2 Nov 1999
- Last updated
- 12 Feb 2008
- Results posted
- No
Publications
Kircanski K, Wu M, Piacentini J. Reduction of subjective distress in CBT for childhood OCD: nature of change, predictors, and relation to treatment outcome. J Anxiety Disord. 2014 Mar;28(2):125-32. doi: 10.1016/j.janxdis.2013.05.004. Epub 2013 May 21.
PubMed 23774008Piacentini J, Bergman RL, Chang S, Langley A, Peris T, Wood JJ, McCracken J. Controlled comparison of family cognitive behavioral therapy and psychoeducation/relaxation training for child obsessive-compulsive disorder. J Am Acad Child Adolesc Psychiatry. 2011 Nov;50(11):1149-61. doi: 10.1016/j.jaac.2011.08.003. Epub 2011 Sep 22.
PubMed 22024003
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavior Therapy for Childhood OCD
- ClinicalTrials.gov ID
- NCT00000386
- Acronym / sponsor ID
- R01MH058459
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Adolescence, Child, Comparative Study, Family, Female, Human, Male, Obsessive-Compulsive Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Dec 1998
- Study completion
- Nov 2003
- First posted
- 3 Nov 1999 (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 this study is to evaluate a behavioral treatment program for children and adolescents with OCD and their families. Exposure and Response Prevention (ERP) behavior therapy, in which the patient is gradually exposed to the object or situation that causes anxiety and is taught to refrain from responding in a compulsive manner, is combined with family counseling (Family Treatment Program). This treatment will be compared to Relaxation Training (RT).
OCD is a long-term, often disabling disorder that can cause significant family disruption. ERP is a promising treatment for children with OCD, and it is thought that family participation (through the Family Treatment Program) may be a helpful addition. RT is a common treatment for anxiety.
Patients are assigned randomly (like tossing a coin) to receive either the ERP/Family Treatment Program or RT. Both treatments will be delivered over 12 90-minute outpatient sessions to youngsters and their families. All participants (patients and family members) will be assessed for treatment response each month during treatment, after treatment is finished, and then at 2 follow-up visits over the following 6 months.
A child/adolescent may be eligible for this study if he/she:
Has obsessive-compulsive disorder (OCD), is medication-free, and is 8 to 17 years old.
Detailed description
To evaluate a standardized multicomponent cognitive behavioral treatment program for child and adolescent obsessive-compulsive disorder (OCD). The treatment program consists of individual Exposure and Response Prevention (ERP) for the OCD child plus a concurrent family intervention designed to reduce OCD-related family conflict, facilitate family disengagement from the affected child's OCD behavior, and rebuild normal family interaction patterns. The ERP/Family Treatment Program is compared with Relaxation Training (RT).
OCD is a chronic, often disabling disorder in childhood that has been associated with increased rates of parental psychopathology and significant disruptions in family relationships and functioning. Preliminary studies suggest that ERP is an effective treatment for children with OCD although no controlled trials to this effect have been published. RT was selected as the comparison treatment because of its credibility as an anxiety treatment and familiarity to potential subjects. RT has been used as a comparison condition for at least 2 randomized controlled ERP trials for adult OCD and shown to be ineffective in treating this disorder. Although it has long been hypothesized that family participation in treatment may be helpful, this is the first controlled study incorporating a systematic manualized family treatment component.
Participants are randomly assigned to receive either the combined ERP/Family Treatment Program (n=56) or RT (n=24). Both treatments are delivered over 12 90-minute outpatient sessions according to detailed treatment manuals.Youth and families undergo comprehensive and systematic, including behavioral, assessments by blind clinical evaluators at baseline, monthly during treatment, post-treatment and 2 follow-up evaluations over 6 months. Treatment outcome is examined in multimodal fashion and across multiple functional domains with a special emphasis on family contextual variables. The impact of baseline functioning, including family context, and initial change over time on treatment outcome is also systematically evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- -
- Obsessive-compulsive disorder for which he/she has not received medication.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Exposure and Response Prevention | Behavioural | – |
| Family Treatment Program | Behavioural | – |
| Relaxation Training | Behavioural | – |
| Behavior therapy | Behavioural | – |
| Family Counseling | Behavioural | – |
Primary outcome
Not reported in the source record.
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 12 Feb 2008.
- Derived from this study: PubMed 23774008Kircanski K, Wu M, Piacentini J. Reduction of subjective distress in CBT for childhood OCD: nature of change, predictors, and relation to treatment outcome. J Anxiety Disord. 2014 Mar;28(2):125-32. doi: 10.1016/j.janxdis.2013.05.004. Epub 2013 May 21.
- Derived from this study: PubMed 22024003Piacentini J, Bergman RL, Chang S, Langley A, Peris T, Wood JJ, McCracken J. Controlled comparison of family cognitive behavioral therapy and psychoeducation/relaxation training for child obsessive-compulsive disorder. J Am Acad Child Adolesc Psychiatry. 2011 Nov;50(11):1149-61. doi: 10.1016/j.jaac.2011.08.003. Epub 2011 Sep 22.
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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.
John C. Piacentini, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exposure and Response Prevention, Family Treatment Program and Relaxation Training in people with Obsessive-Compulsive Disorder, run by National Institute of Mental Health (NIMH) 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 0 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 12 Feb 2008. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000386, which also lists 2 linked publications.
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 12 Feb 2008.