Treatment Study for Rural Latino Youth With Anxiety

NCT01491880 | Completed Phase 1 DMC

• 2 other identifiers: MH090149R34MH090149
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

cognitive behavior therapy; telemedicine; rural; Latinos; children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Barriers to Treatment Participation Scale

  Pretreatment & Posttreatment (maximum of 6 months after randomization)

Study Arms (2)

Child Anxiety Program by Telephone

EXPERIMENTAL

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

Child Anxiety Program- Self Help

EXPERIMENTAL

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

Interventions

Therapist-Assisted by Telephone 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 by Telephone

Self-Help 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.

Child Anxiety Program- Self Help

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of California, San Diego

San Diego, California, 92123, United States

Location

Related Publications (1)

• 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.

  PMID: 29792485 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Mental Disorders; Neurodevelopmental Disorders; Phobic Disorders

Study Officials

• Denise A Chavira, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2011
• First Posted: December 14, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 15, 2019

Record last verified: 2019-08

Locations

US (1)