Treatment Study for Rural Latino Youth With Anxiety

NCT ID: NCT01491880

Last Updated: 2019-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-06-30

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.

Conditions

Anxiety Disorders; Separation Anxiety Disorder; Social Anxiety Disorder; Specific Phobia; Generalized Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Therapist-Assisted by Telephone

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Self-Help

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denise A Chavira, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

University of California, San Diego

San Diego, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29792485 (View on PubMed)

Other Identifiers

R34MH090149

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MH090149

Identifier Type: -

Identifier Source: org_study_id