Computerized Cognitive Behavioral Therapy for Childhood Anxiety in Community Health Centers

June 17, 2019 updated by: University of South Florida

Utilizing Health Information Technology to Improve Health Care Quality: Implementation of a Computerized Cognitive Behavioral Therapy Protocol for Childhood Anxiety

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Clearwater, Florida, United States
        • Directions for Mental Health
      • Fort Lauderdale, Florida, United States
        • Henderson Behavioral Health
      • Pensacola, Florida, United States
        • Access Behavioral Health
      • Tampa, Florida, United States, 33629
        • Eric Storch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PARS
Time Frame: 14 Weeks
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. The scale score ranges from 0 to 30 with higher scores reflecting worse anxiety. The score, ranging from 0-30 represents a total score by summing all 6 items (which have item response options ranking from 0 to 5 each).
14 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ADIS-C/P Clinical Severity Rating
Time Frame: 14 weeks
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). The Clinical Severity Rating score is a one item metric reflecting the severity of the anxiety diagnosis. This is rated by the clinician based on their interview with the patient and parent, together with their judgment. The Rating ranges from 0 to 8 with higher scores reflecting worse anxiety.
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of South Florida

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Access Behavioral Health
Henderson Behavioral Health
Directions for Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R18HS018665 (U.S. AHRQ Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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