DepressionPhase 1NCT00099827
Teen Depression Awareness Project (TDAP)
A Phase 1 study testing Education in people with Depression, run by RAND at 8 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Depression
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 368 participants
- Where
- 8 sitesUnited States
- Study dates
- Oct 2003to Sep 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Between the ages of 13-17
- Attending School
- Living with parent or guardian
- Reads and writes English
- Receiving care at a participating PCP office
Who cannot join
- Pregnancy
- Parents don't speak English or Spanish
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Capital Medical Group
Chevy Chase, Maryland, 20815
Kaiser Mid-Atlantic
Kensington, Maryland, 20895
Family Care Specialists at White Memorial Medical Center
Los Angeles, California, 90033
Kaiser Mid-Atlantic
Rockville, Maryland, 20852
Northeast Valley Health Corporation-San Fernando Valley High School
San Fernando, California, 91340
Kaiser Mid-Atlantic-Camp Springs
Temple Hills, Maryland, 20748
Children's National Medical Center Adolescent Health Clinic
Washington D.C., District of Columbia, 20010
Children's Pediatricians and Associates
Washington D.C., District of Columbia, 20037
About this study
Official title: Teen Depression Awareness Project- This Project Examines the Services Used by Teens Identified in Primary Care Settings With Depression
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.
Read the 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:
- Describe the impact of depression on adolescent and family functioning compared to that of healthy adolescents.
- Evaluate the effect of two interventions--depression diagnosis feedback and an educational brochure, with or without patient activation, on care received.
- 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.
- Conditions
- Depression
- Being tested
- Education
- Keywords
- Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Individuals will receive information about depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of Care
Measured: September 30, 2007
Secondary outcomes (2)
Journal Article
Measured: September, 2007
Journal Articles
Measured: September, 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2004 (estimated)
- Study startOct 2003
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Investigators
- Audrey Burnam, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00099827
- Sponsor's protocol ID
- TDAP2
- Status last verified
- Oct 2011
- First submitted
- 21 Dec 2004
- Last updated
- 18 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teen Depression Awareness Project- This Project Examines the Services Used by Teens Identified in Primary Care Settings With Depression
- ClinicalTrials.gov ID
- NCT00099827
- Acronym / sponsor ID
- TDAP2
- Conditions
- Depression
- Keywords
- Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 21 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Describe the impact of depression on adolescent and family functioning compared to that of healthy adolescents.
- Evaluate the effect of two interventions--depression diagnosis feedback and an educational brochure, with or without patient activation, on care received.
- 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Between the ages of 13-17
- Attending School
- Living with parent or guardian
- Reads and writes English
- Receiving care at a participating PCP office
Key exclusion criteria (2 listed)
- Pregnancy
- Parents don't speak English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationIndividuals will receive information about depression | Behavioural | – |
Primary outcome
Receipt of Care
Time frame: September 30, 2007
2 secondary outcomes
Journal Article
Time frame: September, 2007
Journal Articles
Time frame: September, 2007
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audrey Burnam, PhD principal investigator
RAND
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Education in people with Depression, run by RAND at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receipt of Care (time frame: September 30, 2007). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2011.