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	Treatment or Intervention	Phase
Depression	Behavior: Education	Phase I

Further Study Details: 

Primary Outcomes: Receipt of Care
Expected Total Enrollment:  800

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.

Ages Eligible for Study:  13 Years   -   17 Years,  Genders Eligible for Study:  Both

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

Audrey Burnam, PhD      (310) 393-0411  Ext. 6370    Audrey_Burnam@rand.org
Lisa Jaycox, PhD      (310) 393-0411  Ext. 5118    Lisa_Jaycox@rand.org

California
      Northeast Valley Health Corporation-San Fernando Valley High School, San Fernando,  California,  91340,  United States; Recruiting
      Family Care Specialists at White Memorial Medical Center, Los Angeles,  California,  90033,  United States; Recruiting
District of Columbia
      Children's National Medical Center Adolescent Health Clinic, Washington,  District of Columbia,  20010,  United States; Not yet recruiting
      Children's Pediatricians and Associates, Washington,  District of Columbia,  20037,  United States; Not yet recruiting
Maryland
      Capital Medical Group, Chevy Chase,  Maryland,  20815,  United States; Not yet recruiting
      Kaiser Mid-Atlantic, Rockville,  Maryland,  20852,  United States; Not yet recruiting
      Kaiser Mid-Atlantic-Camp Springs, Temple Hills,  Maryland,  20748,  United States; Not yet recruiting
      Kaiser Mid-Atlantic, Kensington,  Maryland,  20895,  United States; Not yet recruiting

Study chairs or principal investigators

Audrey Burnam, PhD,  Principal Investigator,  RAND   

Study ID Numbers:  TDAP2
Record last reviewed:  December 2004
Last Updated:  December 20, 2004
Record first received:  December 20, 2004
ClinicalTrials.gov Identifier:  NCT00099827
Health Authority: United States: Institutional Review Board (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-04-08