We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Treatment Study for Rural Latino Youth With Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01491880
Recruitment Status : Unknown
Verified January 2012 by Denise A. Chavira, University of California, San Diego.
Recruitment status was:  Recruiting
First Posted : December 14, 2011
Last Update Posted : January 18, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Separation Anxiety Disorder Social Anxiety Disorder Specific Phobia Generalized Anxiety Disorder Behavioral: Therapist-Assisted by Telephone Behavioral: Self-Help Phase 1 Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feasible Delivery of CBT for Rural Latino Youth With Anxiety
Study Start Date : November 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Child Anxiety Program by Telephone
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.
Behavioral: Therapist-Assisted by Telephone
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.
Experimental: Child Anxiety Program- Self Help
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.
Behavioral: Self-Help
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.

Outcome Measures

Primary Outcome Measures :
  1. Consumer Satisfaction Questionnaire [ Time Frame: Pre-treatment and Post-treatment (maximum of 6 months after randomization) ]

    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 :
  1. Barriers to Treatment Participation Scale [ Time Frame: Pretreatment & Posttreatment (maximum of 6 months after randomization) ]
    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.

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491880

Contact: Denise A Chavira, PhD 858-966-7703 ext 2824 dchavira@ucsd.edu
Contact: Cristina E Bustos, PhD 858-966-7703 ext 6904 cbustos@ucsd.edu

United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92123
Principal Investigator: Denise A Chavira, PhD         
Sponsors and Collaborators
University of California, San Diego
National Institute of Mental Health (NIMH)
Principal Investigator: Denise A Chavira, PhD University of California, San Diego
More Information

Responsible Party: Denise A. Chavira, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01491880     History of Changes
Other Study ID Numbers: MH090149
R34MH090149 ( U.S. NIH Grant/Contract )
First Posted: December 14, 2011    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012

Keywords provided by Denise A. Chavira, University of California, San Diego:
cognitive behavior therapy

Additional relevant MeSH terms:
Anxiety Disorders
Phobia, Social
Anxiety, Separation
Pathologic Processes
Mental Disorders
Phobic Disorders
Neurodevelopmental Disorders