Computerized Cognitive Behavioral Therapy for Childhood Anxiety in Community Health Centers

Completed · Phase 3

Conditions studied: Generalized Anxiety Disorder, Social Phobia, Separation Anxiety Disorder

In brief

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 offer insight into the feasibility of providing this intervention in community health centers, while the second phase will compare CCBT to treatment as usual.

Key facts

Study ID

NCT01416805

Run by

University of South Florida

People needed

100

Starts

2011-08-01

Expected to finish

2015-12-01

Last updated by the study team

2019-06-18

Who can join

Age: 7 and older, up to 13. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Directions for Mental Health — Clearwater, Florida, United States
• Henderson Behavioral Health — Fort Lauderdale, Florida, United States
• Access Behavioral Health — Pensacola, Florida, United States
• Eric Storch — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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