Status:
COMPLETED
Computerized Cognitive Behavioral Therapy for Childhood Anxiety in Community Health Centers
Lead Sponsor:
University of South Florida
Collaborating Sponsors:
Access Behavioral Health
Henderson Behavioral Health
Conditions:
Generalized Anxiety Disorder
Social Phobia
Eligibility:
All Genders
7-13 years
Phase:
PHASE3
Brief Summary
This study will examine the efficacy of a computerized cognitive behavioral therapy (CCBT) program for children with anxiety disorders in community health centers. The first phase of the study will of...
Detailed Description
Childhood anxiety disorders are quite common and associated with significant psychosocial impairment and distress. Offering equivalent efficacy to pharmacotherapy without the common side effect profil...
Eligibility Criteria
Inclusion
- Outpatient boys and girls with an anxiety disorder (see below) aged 7-13 years.
- Meets DSM-IV criteria for a diagnosis of one of the following anxiety disorders: separation anxiety disorder (SAD), generalized anxiety disorder (GAD), or social phobia.
- Minimum score of 14 on the PARS Severity Scale.
- The child has a Full Scale IQ greater than 80 as assessed on the Wechsler Abbreviated Scale of Intelligence.
- Have home access to a computer with internet connection.
Exclusion
- Receiving concurrent psychotherapy or other counseling services.
- New Treatments: Initiation of an antidepressant within 12 weeks before study enrollment or an antipsychotic 6 weeks before study enrollment. No new alternative medications, nutritionals or therapeutic diets within 6 weeks of study enrollment. However, pharmacological interventions may be initiated or added if the child is randomized to the Treatment as Usual arm in Phase II.
- Established Treatment changes: Any change in established psychotropic medication (e.g., antidepressants, anxiolytics) within 8 weeks before study enrollment (6 weeks for antipsychotic). Alternative medications that might have behavioral effects must be stable for 6 weeks prior to the study baseline assessment. Any medications that the child is on must remain stable during treatment unless s/he is randomized to the Treatment as Usual arm in Phase II.
- (a) Current clinically significant suicidality or (b) individuals who have engaged in suicidal behaviors within 6 months.
- Lifetime DSM-IV bipolar disorder, schizophrenia, or schizoaffective disorder.
- Unwillingness of parents to make the commitment to accompany their children for study visits/assessments.
- Presence of a significant and/or unstable medical illness which might lead to hospitalization during the study.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01416805
Start Date
August 1 2011
End Date
December 1 2015
Last Update
June 18 2019
Active Locations (4)
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1
Directions for Mental Health
Clearwater, Florida, United States
2
Henderson Behavioral Health
Fort Lauderdale, Florida, United States
3
Access Behavioral Health
Pensacola, Florida, United States
4
Eric Storch
Tampa, Florida, United States, 33629