Teen Depression Awareness Project (TDAP)

This study has been completed.
Sponsor:
Information provided by:
RAND
ClinicalTrials.gov Identifier:
NCT00099827
First received: December 21, 2004
Last updated: October 14, 2011
Last verified: October 2011
  Purpose

The main objective of this research project is to describe the impact of depression on adolescent and family functioning compared to that of healthy adolescents and to understand the impact of Feedback and Patient Activation (FPA) on teen and family decision-making regarding seeking care for depressive disorders.


Condition Intervention Phase
Depression
Behavioral: Education
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Teen Depression Awareness Project- This Project Examines the Services Used by Teens Identified in Primary Care Settings With Depression

Further study details as provided by RAND:

Primary Outcome Measures:
  • Receipt of Care [ Time Frame: September 30, 2007 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Journal Article [ Time Frame: September, 2007 ] [ Designated as safety issue: No ]
  • Journal Articles [ Time Frame: September, 2007 ] [ Designated as safety issue: No ]

Enrollment: 368
Study Start Date: October 2003
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Education
    Individuals will receive information about depression
  Hide Detailed Description

Detailed Description:

Background: Depressive disorders are common among adolescents, and efficacious treatments are available. However, few adolescents receive appropriate care, and the effects of these disorders on adolescents' functioning and family burden are not well understood. Documenting these effects could make identifying and treating adolescents with mental health problems a higher priority for providers and parents, and for the adolescents themselves, than it is now.

Primary care settings provide the most important opportunities to improve care for mood and anxiety disorders among adolescents, since most children and adolescents have some contact with a primary care provider each year for well-child visits, school physicals, or acute care. However, an ongoing trial of a quality improvement intervention for depressed adolescents in primary care settings (RAND's Youth Partners in Care study) suggests that there are significant barriers to implementing quality improvement protocols in primary care.

Study Goals: The main objective of this research is to build an empirical foundation for developing effective strategies to improve treatment of adolescent mood and anxiety disorders in primary care settings. Our specific goals are to:

  1. Describe the impact of depression on adolescent and family functioning compared to that of healthy adolescents.
  2. Evaluate the effect of two interventions--depression diagnosis feedback and an educational brochure, with or without patient activation, on care received.
  3. Identify barriers and facilitators to receiving appropriate care for identified adolescent depression from the perspective of adolescents, parents, and the primary care providers.

Methodology: Participants for this study will be recruited from three to four study sites in each of two cities selected from among eligible general health care settings that serve high volumes of adolescent patients, including a large community-based clinic and a set of small clinics; a high school-based health clinic; and a public/free clinic.

Specific aim 1: We will describe the impact of depression on adolescent and family functioning compared to healthy controls using a 2-group longitudinal comparison between 400 adolescents identified at baseline with major depression, and 400 adolescents with no detectable mental disorders. Primary data will be collected from three types of respondents: adolescents aged 13-17, their parents, and their health care providers. Adolescent baseline and follow-up assessments (for behavioral problems, physical health, health-related quality of life, use of psychotropic medications, etc.) will be conducted through telephone interviews supplemented by mailed questionnaires. Parents will be asked to complete baseline and follow-up assessments to determine family burden, health insurance, demographics, and the adolescent's functioning at school. Study participants will be assessed twice, 6 months apart, with an interim contact at 3 months. Primary care providers (PCPs) will complete written questionnaires that will include data on demographic characteristics, medical background and training, professional practices, as well as knowledge, attitudes and reported treatment behaviors.

Specific aim 2: We will evaluate the effect of the intervention on care received by randomizing half of the 400 adolescents with major depression to one of two conditions--Feedback and Educational Brochure, with and without Patient Activation (FPA) and then observing service use over the next 6 months. The minimal intervention consists of feedback about the diagnosis to the primary care provider, teen and parent, and also includes an educational brochure to teens and parents. In the more active FPA intervention, in addition to feedback and educational brochure, telephone calls will be made to depressed teens and their parents to discuss symptoms and alternative treatment options with the aim of encouraging help-seeking. We will compare the two groups on whether they received mental health care, what kind, and their satisfaction with that care.

Specific aim 3: For the 400 depressed teens in the study, we will conduct a descriptive analysis of the preferences for treatment, barriers encountered, and use of services. We will obtain this information from the teens', parents', and providers' perspectives in order to identify barriers and facilitators to receiving appropriate care.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between the ages of 13-17
  • Attending School
  • Living with parent or guardian
  • Reads and writes English
  • Receiving care at a participating PCP office

Exclusion Criteria:

  • Pregnancy
  • Parents don't speak English or Spanish
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099827

Locations
United States, California
Family Care Specialists at White Memorial Medical Center
Los Angeles, California, United States, 90033
Northeast Valley Health Corporation-San Fernando Valley High School
San Fernando, California, United States, 91340
United States, District of Columbia
Children's National Medical Center Adolescent Health Clinic
Washington, District of Columbia, United States, 20010
Children's Pediatricians and Associates
Washington, District of Columbia, United States, 20037
United States, Maryland
Capital Medical Group
Chevy Chase, Maryland, United States, 20815
Kaiser Mid-Atlantic
Kensington, Maryland, United States, 20895
Kaiser Mid-Atlantic
Rockville, Maryland, United States, 20852
Kaiser Mid-Atlantic-Camp Springs
Temple Hills, Maryland, United States, 20748
Sponsors and Collaborators
RAND
Investigators
Principal Investigator: Audrey Burnam, PhD RAND
  More Information

Additional Information:
No publications provided

Responsible Party: Audrey Burnam, RAND
ClinicalTrials.gov Identifier: NCT00099827     History of Changes
Other Study ID Numbers: TDAP2
Study First Received: December 21, 2004
Last Updated: October 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by RAND:
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014