Evaluating the Effectiveness of Early Cognitive Behavioral Therapy With or Without Parental Involvement in Treating Anxious Children
Early Interventions for Anxious Children
2 other identifiers
interventional
61
1 country
1
Brief Summary
This study will evaluate the effectiveness of school-based cognitive behavioral therapy with or without parental involvement in treating anxious children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2002
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 13, 2007
CompletedFirst Posted
Study publicly available on registry
November 14, 2007
CompletedNovember 1, 2019
October 1, 2019
4.8 years
November 13, 2007
October 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite Clinician Severity Rating (CSR) on the Anxiety Disorders Interview Schedule (ADIS) for DSM-IV for primary anxiety diagnosis
Measured at Month 6 and Years 1, 2, 3, and 4 post-treatment
Secondary Outcomes (1)
Multidimensional Anxiety Scale for Children, Scale for Child Anxiety Related Emotional Disorders, Clinical Global Impressions-Improvement Scale, Family Adaptability and Cohesion Evaluation Scale II, and Behavior Assessment System for Children
Measured at Months 3 and 6 and Years 1, 2, 3, and 4 post-treatment
Study Arms (3)
1
EXPERIMENTALCBT for children only
2
EXPERIMENTALCBT for children with parental involvement
3
NO INTERVENTIONNo intervention control group: families free to seek treatment on their own
Interventions
CBT for children consists of 9 weekly group CBT sessions. All sessions occur in the school building during after-school hours.
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
You may qualify if:
- Total Anxiety T-score of greater than 57 on Multidimensional Anxiety Scale for Children and/or teacher nomination as one of the most anxious children in the classroom
- 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
You may not qualify if:
- Current diagnosis of the following on ADIS: obsessive-compulsive disorder, posttraumatic stress disorder, attention-deficit hyperactivity disorder, conduct disorder, schizophrenia, pervasive developmental disorder, major depression, or substance abuse
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Divisions of Child and Adolescent Psychiatry, University of Minnesota Medical School
Minneapolis, Minnesota, 55454, United States
Related Publications (7)
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.
PMID: 16239860RESULTBernstein 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.
PMID: 15927779RESULTLayne 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.
PMID: 16736381RESULTVictor 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.
PMID: 17161582RESULTBernstein 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.
PMID: 17557318RESULTBernstein 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.
PMID: 18665000RESULTLayne 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.
PMID: 18815006RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gail A. Bernstein, MD
Division of Child and Adolescent Psychiatry, University of Minnesota Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2007
First Posted
November 14, 2007
Study Start
October 1, 2002
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
November 1, 2019
Record last verified: 2019-10