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| Descriptive Information Fields | |||||
| Brief Title † | Parent-Augmented Cognitive Behavioral Therapy to Treat Children With Specific Phobias | ||||
| Official Title † | Augmented Treatment of Specific Phobias in Children | ||||
| Brief Summary | This study will compare the effectiveness of two types of cognitive behavioral therapy, one-session exposure treatment and family-enhanced one-session exposure treatment, in treating children with specific phobias. |
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| Detailed Description | A specific phobia is a fear of a particular object or situation. For many children, phobias result in considerable academic difficulties, social and personal distress, and interference in day-to-day activities. Physical symptoms typically accompany the intense anxiety caused by a specific phobia and may include blushing, profuse sweating, trembling, nausea, and difficulty talking. Phobias can persist a lifetime and may lead to other adult anxiety, mood, and substance use disorders. One-session exposure treatment (OST), a form of cognitive behavior therapy, has been considered a rapid and effective treatment for adults with a variety of specific phobias. Upward of 75 to 80% of adults treated with OST were considered diagnoses free following treatment. OST has proven useful in treating some children with specific phobias but not all. It is possible that parental factors may affect whether a child continues to experience a phobia and how well a child responds to treatment. For example, parents who are overly protective or have a phobia themselves may prevent their child from overcoming a specific phobia. Family-enhanced OST (augmented OST) involves the parents of affected children and provides the parents with strategies to assist their children in overcoming phobias. This study will compare the effectiveness of OST and augmented OST in treating children with specific phobias. This study will also evaluate how parental factors influence the expression and maintenance of phobias in children. Participants in this study will be randomly assigned to receive OST or augmented OST. Participants receiving OST will attend one extended treatment session, lasting up to 3 hours in duration. During this session, the child will be taught a number of cognitive and behavioral skills to deal effectively with the feared situation or object. The child will also be exposed to the feared situation or object in a highly structured, safe, and controlled manner. This treatment will only be delivered to the child and will not involve a parent or guardian. Participants receiving augmented OST will attend the same type of extended treatment session, but, in addition, their parent or guardian will attend a 3-hour session. During this session, parents will first be educated on specific phobias, including why phobias occur and how they are maintained over time. Next, parents will observe their child being treated from behind a one-way mirror for about 1 hour. During this time, a therapist will explain what the child's therapist is doing and discuss ways for parents to implement the treatment at home. Parents will then be asked to join their child and the therapist for the last hour of the child's session to assist the therapist with treatment. Outcomes will be assessed for all participants immediately after treatment and at 1-, 6-, and 12-month follow-up evaluations during which the presence of specific phobias will be measured. Parents will also be asked to provide information about their child's school grades and school attendance for the year prior to participating in the study and up to 1 year after the child completes the treatment. The child's teacher may be asked to complete a questionnaire regarding the child's behavior in school. All of the information collected will help to determine how much progress each child has made as a result of treatment. |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Anxiety Disorders Interview Schedule for DSM-IV: Presence of Specific Phobia [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ] Clinical Global Impression: Severity of Specific Phobia [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | |||||
| Condition † | Anxiety Disorders Specific Phobia |
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| Intervention † | Behavioral: One-session exposure treatment Behavioral: Augmented one-session exposure treatment |
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| MEDLINE PMIDs | |||||
| Links | Click here for more information on the treatment of specific phobias ![]() Click here for the Child Study Center, Department of Psychology, Virginia Tech Web site  ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 154 | ||||
| Start Date † | July 2007 | ||||
| Completion Date | July 2011 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 7 Years to 12 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00509951 | ||||
| Organization ID | R01 MH074777 | ||||
| Secondary IDs †† | DSIR 84-CTS | ||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | July 2008 | ||||
| First Received Date † | July 30, 2007 | ||||
| Last Updated Date | July 2, 2008 | ||||