Computerized Cognitive Behavioral Therapy for Childhood Anxiety in Community Health Centers
Condition: Generalized Anxiety Disorder; Social Phobia; Separation Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social; Anxiety, Separation
Intervention: Computerized Cognitive Behavioral Therapy; Treatment as usual
Intervention description: Those who choose to participate will be enrolled in the 14 week study (18 weeks for phase II). They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 14) (and a 4th assessment for a 1 month Follow-up for Phase II at week 18). This group will follow the CCBT protocol (Camp Cope-A-lot), which is the computer-assisted intervention for anxious children being examined in this study. The first 6 levels of this program are skill building levels to be completed by the user in his/her own home. The remaining 6 levels are completed with the therapist and consist of exposure tasks and rehearsal geared toward each child.; Those who choose to participate will be enrolled in the 14 week study (18 weeks for phase II). They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 14) (and a 4th assessment for a 1 month Follow-up for Phase II at week 18). Those in this group will not receive the CCBT, and instead will undergo therapy for their anxiety as they usually would, whether by using medication or working with a therapist.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 7 Years
Maximum age: 13 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: childhood anxiety disorders; cognitive behavioral therapy; CBT; Generalized Anxiety Disorder; Social Phobia; Separation Anxiety Disorder; Psychotherapy; Counseling; Social Anxiety Disorder

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

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.