Ignite Creation Date:
2024-05-04 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000386
Status:
COMPLETED
Last Update Posted:
2008-02-12
First Post:
1999-11-02
Brief Title:
Behavior Therapy for Children and Adolescents With Obsessive-Compulsive Disorder OCD
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institute of Mental Health NIMH
Study Overview
Official Title:
Behavior Therapy for Childhood OCD
Status:
COMPLETED
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 ERPFamily 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 childadolescent may be eligible for this study if heshe
Has obsessive-compulsive disorder OCD is medication-free and is 8 to 17 years old
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 ERPFamily 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 childadolescent may be eligible for this study if heshe
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 childs OCD behavior and rebuild normal family interaction patterns The ERPFamily 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 ERPFamily Treatment Program n56 or RT n24 Both treatments are delivered over 12 90-minute outpatient sessions according to detailed treatment manualsYouth 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
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 ERPFamily Treatment Program n56 or RT n24 Both treatments are delivered over 12 90-minute outpatient sessions according to detailed treatment manualsYouth 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR CT-S | None | None | None |