Evaluating the Effectiveness of Early Cognitive Behavioral Therapy With or Without Parental Involvement in Treating Anxious Children
NCT ID: NCT00557648
Last Updated: 2019-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
61 participants
INTERVENTIONAL
2002-10-31
2007-07-31
Brief Summary
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Detailed Description
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Participants in this single blind study will be randomly assigned by school to one of three treatment groups: CBT for children only, CBT for children plus parent training, and no-treatment control. Each child and parent participant will first undergo an interview, lasting between 1 and 1.5 hours, about the child's symptoms. Additionally, parents will complete rating scales about their children's symptoms and their own symptoms. The participants receiving CBT will then attend 9 weekly group sessions held in the school buildings after school. In the parental involvement group, parents will attend 9 weekly group parent-training sessions held at the same time as the children's CBT group sessions. During the children's CBT sessions, participants will learn techniques to identify feelings of worry, relax, modify negative thoughts, break down difficult situations into smaller achievable steps, reward themselves for trying hard, and maintain treatment gains. For the parent training group, early sessions will focus on normalizing anxiety during childhood, learning about anxiety, and identifying when their children are feeling anxious. The middle sessions will teach parents the same anxiety management skills being taught to their children and ways to help their children to apply the steps at home. The latter sessions will instruct parents on ways to encourage their children's behaviors in anxiety-provoking situations. After completing the 9-week program, participants will attend 2 follow-up booster sessions at Months 1 and 3 post-treatment. Follow-up assessments will occur at Months 3 and 6 and at Years 1, 2, 3, and 4 post-treatment. The assessments will include repeat interviews and rating scales. At the end of the 6-month follow-up assessment, participants in the no-treatment control group will have the opportunity to participate in the CBT group treatments.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
CBT for children only
Group CBT for children
CBT for children consists of 9 weekly group CBT sessions. All sessions occur in the school building during after-school hours.
2
CBT for children with parental involvement
Group CBT for children plus parent training
CBT involving children and parents consists of 9 weekly group CBT sessions for the children and 9 weekly concurrent group parent training sessions.
3
No intervention control group: families free to seek treatment on their own
No interventions assigned to this group
Interventions
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Group CBT for children
CBT for children consists of 9 weekly group CBT sessions. All sessions occur in the school building during after-school hours.
Group CBT for children plus parent training
CBT involving children and parents consists of 9 weekly group CBT sessions for the children and 9 weekly concurrent group parent training sessions.
Eligibility Criteria
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Inclusion Criteria
* Meets DSM-IV criteria for separation anxiety disorder, generalized anxiety disorder, and/or social phobia, or features (one or more, but not all criteria) of one of these disorders with an associated composite CSR of 2 to 6 on ADIS
* Both parent and child speak English fluently
Exclusion Criteria
* Current suicidal or homicidal intent or plan
* Diagnosis of mental retardation (IQ less than 71) on the Kaufman Brief Intelligence Test (KBIT)
* Currently receiving psychotropic medication
7 Years
11 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Gail A. Bernstein, MD
Role: PRINCIPAL_INVESTIGATOR
Division of Child and Adolescent Psychiatry, University of Minnesota Medical School
Locations
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Divisions of Child and Adolescent Psychiatry, University of Minnesota Medical School
Minneapolis, Minnesota, United States
Countries
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References
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Bernstein GA, Layne AE, Egan EA, Tennison DM. School-based interventions for anxious children. J Am Acad Child Adolesc Psychiatry. 2005 Nov;44(11):1118-27. doi: 10.1097/01.chi.0000177323.40005.a1.
Bernstein GA, Layne AE, Egan EA, Nelson LP. Maternal phobic anxiety and child anxiety. J Anxiety Disord. 2005;19(6):658-72. doi: 10.1016/j.janxdis.2004.09.001.
Layne AE, Bernstein GA, March JS. Teacher awareness of anxiety symptoms in children. Child Psychiatry Hum Dev. 2006 Summer;36(4):383-92. doi: 10.1007/s10578-006-0009-6.
Victor AM, Bernat DH, Bernstein GA, Layne AE. Effects of parent and family characteristics on treatment outcome of anxious children. J Anxiety Disord. 2007;21(6):835-48. doi: 10.1016/j.janxdis.2006.11.005. Epub 2006 Dec 11.
Bernstein GA, Bernat DH, Davis AA, Layne AE. Symptom presentation and classroom functioning in a nonclinical sample of children with social phobia. Depress Anxiety. 2008;25(9):752-60. doi: 10.1002/da.20315.
Bernstein GA, Bernat DH, Victor AM, Layne AE. School-based interventions for anxious children: 3-, 6-, and 12-month follow-ups. J Am Acad Child Adolesc Psychiatry. 2008 Sep;47(9):1039-47. doi: 10.1097/CHI.ob013e31817eecco.
Layne AE, Bernat DH, Victor AM, Bernstein GA. Generalized anxiety disorder in a nonclinical sample of children: symptom presentation and predictors of impairment. J Anxiety Disord. 2009 Mar;23(2):283-9. doi: 10.1016/j.janxdis.2008.08.003. Epub 2008 Aug 12.
Other Identifiers
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FWA00000312-4
Identifier Type: -
Identifier Source: org_study_id
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