- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01491880
Treatment Study for Rural Latino Youth With Anxiety
Feasible Delivery of CBT for Rural Latino Youth With Anxiety
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 92123
- University of California, San Diego
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Pre-treatment and Post-treatment (maximum of 6 months after randomization)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Pretreatment & Posttreatment (maximum of 6 months after randomization)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Denise A Chavira, PhD, University of California, San Diego
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MH090149
- R34MH090149 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anxiety Disorders
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiRecruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Loyola UniversityCompletedAnxiety | Anxiety State | Procedural AnxietyUnited States
-
Nazife Begüm KARANCompletedDental Anxiety | Sedative; Anxiety DisorderTurkey
-
Eli Lilly and CompanyCompletedAnxiety Neuroses | Anxiety States, Neurotic | Neuroses, AnxietyUnited States, Mexico, South Africa
-
West University of TimisoaraUnknownAnxiety Disorder/Anxiety StateRomania
-
Yale UniversityNational Institute of Mental Health (NIMH)Active, not recruitingGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
Dr. Nazanin AlaviActive, not recruitingGeneralized Anxiety Disorder | AnxietyCanada
-
ProofPilotFisher WallaceActive, not recruitingGeneralized Anxiety Disorder | Anxiety | Generalized AnxietyUnited States
Clinical Trials on Therapist-Assisted by Telephone
-
Karolinska InstitutetRegion StockholmRecruiting
-
The First Hospital of Jilin UniversityRecruiting
-
University of ReginaCompletedDepression, Postpartum | AnxietyCanada
-
Sorlandet Hospital HFCompletedSubstance-Related Disorders | Reminder SystemsNorway
-
New York State Psychiatric InstituteCompletedObsessive Compulsive Disorder (OCD)United States
-
University of CologneCompleted
-
University of PecsCompleted
-
Northwestern UniversityAmerican Pain Society; Rosalind Franklin University of Medicine and Science; Insulin...CompletedDiabetic Neuropathy, Painful
-
Lund UniversityCompleted
-
Karolinska InstitutetNot yet recruiting