Computerized Cognitive Behavioral Therapy for Childhood Anxiety in Community Health Centers

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Access Behavioral Health
Henderson Behavioral Health
Directions for Mental Health
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01416805
First received: August 11, 2011
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Generalized Anxiety Disorder
Social Phobia
Separation Anxiety Disorder
Behavioral: Computerized Cognitive Behavioral Therapy
Behavioral: Treatment as usual
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Utilizing Health Information Technology to Improve Health Care Quality: Implementation of a Computerized Cognitive Behavioral Therapy Protocol for Childhood Anxiety

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • PARS [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
    Pediatric Anxiety Rating Scale (PARS)- The PARS (RUPP, 2002) is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week.


Secondary Outcome Measures:
  • ADIS-C/P [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    Anxiety Disorders Interview Schedule for DSM-IV: Child and Parent Versions (ADIS-IV-C/P)- The ADIS-IV-C/P (Silverman & Albano, 1996) is a clinician-administered, semi-structured interview that assesses for the presence and severity of DSM-IV anxiety disorders as well as Dysthymia and Major Depression, ADHD, Conduct Disorder, and Oppositional-Defiant Disorder. Excellent psychometric properties have been reported (e.g., Wood et al., 2002).


Estimated Enrollment: 188
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Computerized Cognitive Behavioral Therapy Behavioral: Computerized Cognitive Behavioral Therapy
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.
Active Comparator: Treatment as Usual Behavioral: Treatment as usual
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.

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 profile, cognitive behavioral therapy (CBT) is a first line treatment for anxiety disorders in youth. However, dissemination of CBT to community settings is very limited. Effective treatment via traditional CBT often necessitates that the patient travel to a center that specializes in this treatment, and cost can prove an impediment to those of lower socioeconomic status, in particular. As well, differing theoretical approaches and training result in a minority of children with anxiety receiving evidence-based CBT. Accordingly, there is a great need for more widely accessible practices. As such, we are proposing a two phase trial that evaluates the feasibility of implementing a patient-centered intervention in community mental health centers, followed by an efficacy trial. In Phase I, an open trial of computerized CBT (CCBT) will be completed that focuses on feasibility issues of providing this intervention in community mental health centers. Thereafter, we will complete a randomized controlled trial comparing CCBT to treatment as usual (TAU) in Phase II. The open trial will recruit 18 youth ages 7 to 13 years, with the purpose of testing both practicality and management of an already developed CCBT protocol (Kendall & Khanna, 2008). The outcome trial will recruit 110 youth, with the purpose of measuring the efficacy of the CCBT protocol in front-line settings. Significantly greater symptom reductions in the CCBT group as compared to the TAU group would provide critical evidence for the inclusion of CCBT as a treatment option for anxious youth without immediate access to such in-person care. While this study will be coordinated by the University of South Florida Rothman Center for Neuropsychiatry team who is located at All Children's Hospital (USF/ACH), recruitment will take place at three community mental health centers throughout Florida that serve families of lower socioeconomic status. Primary outcomes will be assessed by an independent evaluator, and will include change in anxiety symptom severity; response rates; and remission rates. CCBT will follow the Kendall and Khanna (2008) manual with appropriate integrity checks. The implications of this study are significant, as computerized CBT may enable widespread dissemination of efficacious therapy for anxiety disorders among youth.

  Eligibility

Ages Eligible for Study:   7 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416805

Locations
United States, Florida
Directions for Mental Health
Clearwater, Florida, United States
Henderson Behavioral Health
Ft. Lauderdale, Florida, United States
Access Behavioral Health
Pensacola, Florida, United States
University of South Florida
St. Petersburg, Florida, United States, 33701
Sponsors and Collaborators
University of South Florida
Access Behavioral Health
Henderson Behavioral Health
Directions for Mental Health
Investigators
Principal Investigator: Eric A Storch, Ph.D. University of South Florida
  More Information

Additional Information:
No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01416805     History of Changes
Other Study ID Numbers: 1R18HS018665
Study First Received: August 11, 2011
Last Updated: July 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
childhood anxiety disorders
cognitive behavioral therapy
CBT
Generalized Anxiety Disorder
Social Phobia
Separation Anxiety Disorder
Psychotherapy
Counseling
Social Anxiety Disorder

Additional relevant MeSH terms:
Anxiety Disorders
Anxiety, Separation
Mental Disorders
Phobic Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on July 29, 2014