Computerized Cognitive Behavioral Therapy for Childhood Anxiety in Community Health Centers

NCT01416805 | Completed Phase 3 Results

• 1 other identifier: 1R18HS018665
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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

Conditions

Generalized Anxiety Disorder; Social Phobia; Separation Anxiety Disorder

Keywords

childhood anxiety disorders; cognitive behavioral therapy; CBT; Generalized Anxiety Disorder; Social Phobia; Separation Anxiety Disorder; Psychotherapy; Counseling; Social Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• PARS

  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 Outcomes (1)

• ADIS-C/P Clinical Severity Rating

  14 weeks

Study Arms (2)

Computerized Cognitive Behavioral Therapy

EXPERIMENTAL

Behavioral: Computerized Cognitive Behavioral Therapy

Treatment as Usual

ACTIVE COMPARATOR

Behavioral: Treatment as usual

Interventions

Computerized Cognitive Behavioral Therapy BEHAVIORAL

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.

Computerized Cognitive Behavioral Therapy

Treatment as usual BEHAVIORAL

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.

Treatment as Usual

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• University of South Florida: lead
• Access Behavioral Health: collaborator
• Henderson Behavioral Health: collaborator
• Directions for Mental Health: collaborator

Study Sites (4)

Directions for Mental Health

Clearwater, Florida, United States

Location

Henderson Behavioral Health

Fort Lauderdale, Florida, United States

Location

Access Behavioral Health

Pensacola, Florida, United States

Location

Eric Storch

Tampa, Florida, 33629, United States

Location

Related Publications (2)

• Smarason O, Guzick AG, Goodman WK, Salloum A, Storch EA. Predictors and Moderators of Treatment Outcomes for Anxious Children Randomized to Computer-Assisted Cognitive Behavioral Therapy or Standard Community Care. J Child Adolesc Psychopharmacol. 2023 Oct;33(8):316-324. doi: 10.1089/cap.2023.0019.

  PMID: 37861988 DERIVED

• Storch EA, Salloum A, King MA, Crawford EA, Andel R, McBride NM, Lewin AB. A RANDOMIZED CONTROLLED TRIAL IN COMMUNITY MENTAL HEALTH CENTERS OF COMPUTER-ASSISTED COGNITIVE BEHAVIORAL THERAPY VERSUS TREATMENT AS USUAL FOR CHILDREN WITH ANXIETY. Depress Anxiety. 2015 Nov;32(11):843-52. doi: 10.1002/da.22399. Epub 2015 Sep 14.

  PMID: 26366886 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder; Phobia, Social; Anxiety, Separation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Phobic Disorders; Neurodevelopmental Disorders

Limitations and Caveats

The majority of the sample was Caucasian. Not everyone in Treatment as Usual received active treatment. The 1-month follow-up duration was not sufficient to evaluate long-term treatment maintenance.

Results Point of Contact

• Title: Dr. Eric Storch
• Organization: University of South Florida

Eric.Storch@bcm.edu

727-767-8230

Study Officials

• Eric A Storch, Ph.D.

  University of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: August 15, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 18, 2019
• Results First Posted: June 18, 2019

Record last verified: 2019-03

Locations

US (4)