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Treatment Study for Rural Latino Youth With Anxiety

Primary Purpose

Anxiety Disorders, Separation Anxiety Disorder, Social Anxiety Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Therapist-Assisted by Telephone
Self-Help
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring cognitive behavior therapy, telemedicine, rural, Latinos, children

Eligibility Criteria

8 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Child between ages of 8-13
  • Meets DSM-IV criteria for one of the following disorders: separation anxiety disorder, social phobia, generalized anxiety disorder, specific phobia, or obsessive-compulsive disorder
  • If takes a medication, has maintained a stable dose for 3 months before baseline assessment
  • Pediatric medical care is provided through one of the participating primary care clinics
  • Parent and child are fluent in English or Spanish
  • Family has easy access to a telephone

Exclusion Criteria:

  • Comorbid diagnosis, such as major depression, ADHD, or psychosis that is considered clinically significant and the primary problem
  • Life threatening conditions, active suicidality, psychotic disorders, bipolar disorder or pervasive developmental disorders

Sites / Locations

  • University of California, San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Child Anxiety Program by Telephone

Child Anxiety Program- Self Help

Arm Description

The child anxiety program by telephone is an adaptation of Ron Rapee's Cool Kids Outreach Program (Lyneham and Rapee, 2006) for child anxiety, with appropriate adaptations made to meet the needs of rural Latino families (including a Spanish translation). This is a parent mediated program, where parents are taught how all the skills of cognitive behavior therapy (CBT) and how to apply these skills to these children's anxieties. Children are also expected to participate, however all direct contact that a therapist may have, is with the parent only.

Families randomized to the Self-Help CBT condition will receive program materials along with instructions for completing weekly assignments. Specifically, they will receive the same materials as families in the telephone-based condition however in the self-help group, parents and children are expected to read the materials for that week and complete the workbook activities without planned therapist involvement. Instead they will be given the option to initiate a telephone call to the therapist, if they have questions or need extra support.

Outcomes

Primary Outcome Measures

Consumer Satisfaction Questionnaire
The aim of this pilot study is to understand issues of feasibility rather than formal hypothesis testing. The construct of acceptability will be evaluated by parents' reports on Consumer Satisfaction Questionnaire (March et al., 1999). Overall mean scores reflecting at least "above average" ratings (5 or greater on Consumer Satisfaction) will be considered acceptable.

Secondary Outcome Measures

Barriers to Treatment Participation Scale
Overall feasibility will be defined as the ability to complete the study procedures and goals in the proposed time frame. Further the feasibility of the program will be evaluated by participants' report on the Barriers to Treatment Participation Scale (Kazdin et al., 1997); overall mean scores reflecting that "barriers" were "never a problem, occasionally a problem or sometimes a problem" will be considered acceptable.

Full Information

First Posted
July 29, 2011
Last Updated
August 13, 2019
Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01491880
Brief Title
Treatment Study for Rural Latino Youth With Anxiety
Official Title
Feasible Delivery of CBT for Rural Latino Youth With Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 2011 (Actual)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This pilot study will examine the feasibility of two modes of service delivery (e.g., a minimal therapist contact, self-help program, and a more intensive therapist supported, telephone-based approach) in a rural, primarily Latino, population. These modes of delivery may ultimately improve access to evidence based treatments and mental health outcomes among underserved groups.
Detailed Description
Children with anxiety disorders are often characterized by an unmet need for treatment however, in special populations such as Latino and rural youth, such disparities are compounded by the effects of culture and geographic isolation. More specifically, barriers related to language, stigma, and access often lead to lower rates of utilization and poorer outcomes among children in need of mental health services (Alvidrez and Azocar, 1999; McCabe et al., 2002; Myers et al., 2008; Vega et al., 2001). These findings are disappointing given abundant data supporting the effectiveness of cognitive behavior and behavior therapies for children with anxiety disorders (Barrett et al., 1996; Beidel et al., 2007; Kendall & Southam-Gerow, 1996; Walkup et al., 2008). Efforts to examine feasible methods to deliver evidence-based treatments to children with anxiety disorders are critical in order to extend quality care to underserved groups. The goal of this R34 is to address these disparities, by translating and tailoring an existing child anxiety cognitive behavior therapy program (The Cool Kids Outreach Program; Lyneham and Rapee, 2006), to fit the needs of Spanish-speaking rural families and examining the feasibility, acceptability, tolerability and safety of implementing this intervention using varying modes of delivery. A pilot study for children (age 8-13) with anxiety disorders (i.e., separation anxiety disorder, generalized anxiety disorder, social anxiety disorder, and specific phobias) will be conducted and 40 children will be randomized to two service delivery modes which represent varying levels of therapist contact: 1) 20 families will be randomized to a telephone-based, therapist-supported CBT program, and; 2) 20 families will be randomized to a more minimal contact bibliotherapy condition (primarily CBT self-help materials). All families will be recruited from primary care settings, given its defacto mental health service status. Feasibility and clinical outcomes will be measured at baseline, midtreatment and post-treatment. Additionally, during exit interviews, participants (as well as those who may have dropped out of the program) will be asked to discuss the perceived usefulness, acceptability, and impact of the intervention. This pilot study will provide important data regarding the feasibility, acceptability, tolerability and safety of the intervention conditions as well as the opportunity to pilot procedures that will be used in a larger effectiveness trial with rural Latino youth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Separation Anxiety Disorder, Social Anxiety Disorder, Specific Phobia, Generalized Anxiety Disorder
Keywords
cognitive behavior therapy, telemedicine, rural, Latinos, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Child Anxiety Program by Telephone
Arm Type
Experimental
Arm Description
The child anxiety program by telephone is an adaptation of Ron Rapee's Cool Kids Outreach Program (Lyneham and Rapee, 2006) for child anxiety, with appropriate adaptations made to meet the needs of rural Latino families (including a Spanish translation). This is a parent mediated program, where parents are taught how all the skills of cognitive behavior therapy (CBT) and how to apply these skills to these children's anxieties. Children are also expected to participate, however all direct contact that a therapist may have, is with the parent only.
Arm Title
Child Anxiety Program- Self Help
Arm Type
Experimental
Arm Description
Families randomized to the Self-Help CBT condition will receive program materials along with instructions for completing weekly assignments. Specifically, they will receive the same materials as families in the telephone-based condition however in the self-help group, parents and children are expected to read the materials for that week and complete the workbook activities without planned therapist involvement. Instead they will be given the option to initiate a telephone call to the therapist, if they have questions or need extra support.
Intervention Type
Behavioral
Intervention Name(s)
Therapist-Assisted by Telephone
Intervention Description
Parents will receive educational workbooks and ongoing support over the phone from a child anxiety specialist to learn how to use cognitive behavioral therapy skills to manage their children's fears and worries.
Intervention Type
Behavioral
Intervention Name(s)
Self-Help
Intervention Description
Parents will receive educational workbooks to learn how to use cognitive behavioral therapy skills to manage their children's fears and worries independently. Parents will have the option to access support over the phone from a child anxiety specialist.
Primary Outcome Measure Information:
Title
Consumer Satisfaction Questionnaire
Description
The aim of this pilot study is to understand issues of feasibility rather than formal hypothesis testing. The construct of acceptability will be evaluated by parents' reports on Consumer Satisfaction Questionnaire (March et al., 1999). Overall mean scores reflecting at least "above average" ratings (5 or greater on Consumer Satisfaction) will be considered acceptable.
Time Frame
Pre-treatment and Post-treatment (maximum of 6 months after randomization)
Secondary Outcome Measure Information:
Title
Barriers to Treatment Participation Scale
Description
Overall feasibility will be defined as the ability to complete the study procedures and goals in the proposed time frame. Further the feasibility of the program will be evaluated by participants' report on the Barriers to Treatment Participation Scale (Kazdin et al., 1997); overall mean scores reflecting that "barriers" were "never a problem, occasionally a problem or sometimes a problem" will be considered acceptable.
Time Frame
Pretreatment & Posttreatment (maximum of 6 months after randomization)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Child between ages of 8-13 Meets DSM-IV criteria for one of the following disorders: separation anxiety disorder, social phobia, generalized anxiety disorder, specific phobia, or obsessive-compulsive disorder If takes a medication, has maintained a stable dose for 3 months before baseline assessment Pediatric medical care is provided through one of the participating primary care clinics Parent and child are fluent in English or Spanish Family has easy access to a telephone Exclusion Criteria: Comorbid diagnosis, such as major depression, ADHD, or psychosis that is considered clinically significant and the primary problem Life threatening conditions, active suicidality, psychotic disorders, bipolar disorder or pervasive developmental disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise A Chavira, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29792485
Citation
Chavira DA, Bustos C, Garcia M, Reinosa Segovia F, Baig A, Ng B, Camacho A. Telephone-assisted, parent-mediated CBT for rural Latino youth with anxiety: A feasibility trial. Cultur Divers Ethnic Minor Psychol. 2018 Jul;24(3):429-441. doi: 10.1037/cdp0000186. Epub 2018 May 24.
Results Reference
derived

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Treatment Study for Rural Latino Youth With Anxiety

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