Treatment Study for Rural Latino Youth With Anxiety

Anxiety Disorders Clinical Trial

Official title:

Feasible Delivery of CBT for Rural Latino Youth With Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01491880
• Other study ID #: MH090149
• Secondary ID: R34MH090149
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 2011
• Est. completion date: June 2013

Study information

• Verified date: August 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety, Separation
• Disease
• Generalized Anxiety Disorder
• Phobia, Social
• Separation Anxiety Disorder
• Social Anxiety Disorder
• Specific Phobia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre-treatment and Post-treatment (maximum of 6 months after randomization)
Secondary	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.	Pretreatment & Posttreatment (maximum of 6 months after randomization)