DepressionPhase 1/2NCT00461539
Reducing Health Risk Behavior and Improving Health in Adolescents With Depression
A Phase 1/2 study testing Treatment as usual and Behavioral health intervention in people with Depression and Adolescent Health, run by University of California, Los Angeles at 2 sites in United States.
Trial summary
This study will determine the effectiveness of a health education intervention in reducing health risk behavior and improving health in adolescents with depression. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Depression, Adolescent Health
- What is being tested?
- Treatment as usual and Behavioral health intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2007to Jan 2012
- Phase
- Phase 1/2
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- CIDI diagnosis of major depression or probable depression based on youth self report
- Availability of a family member to provide informed consent
Who cannot join
- Lacks contact information (e.g., address, telephone number)
- Any functioning deficits or other characteristics that might interfere with study participation
- Currently in a living situation that might interfere with study participation (e.g., lives over 1 hour away from the study site)
- Lacks family available to participate in the intervention
- Mental retardation
- Does not speak English or Spanish
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, Los Angeles, Semel Institute for Neuroscience and Human Behavior
Los Angeles, California, 90024
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
About this study
Official title: Reducing Health Risk Behavior and Improving Health in Adolescent Depression
This study will determine the effectiveness of a health education intervention in reducing health risk behavior and improving health in adolescents with depression.
Read the detailed description
Depression is a common disorder among adolescents. If left untreated, it can cause significant disability, illness, and even death. Teens with depression often engage in risky health behaviors, such as smoking, drug and alcohol use, unprotected sex, and unhealthy eating and exercise patterns. By reducing these health risk behaviors, depressed adolescents may be able to avoid negative health consequences and improve their physical and mental health. This study will determine the effectiveness of a health education intervention in reducing risky health behaviors in adolescents with depression.
Participants in this study will be invited to enroll during a visit to a participating primary care clinic. Participants will be randomly assigned to either partake in a health education intervention or receive standard care. Both groups will continue to receive treatment through their primary care clinic. Those participants receiving standard care will be referred to special programs as needed to reduce their involvement in risky health behaviors. Participants assigned to the health education intervention will attend 10 weekly education sessions that will be led by trained health educators. Parents or guardians may be asked to attend sessions depending on their interest in the intervention and the age of the youth participant. Topics covered will include teenage smoking, alcohol and drug abuse, risky sexual behaviors, and obesity. Cognitive-behavioral strategies, role playing, and media clips will be used to stimulate discussion and involvement in the intervention. The intervention will be tailored to target the specific risky behaviors in which each participant engages. Motivational interviewing will also be used to build positive attitudes to support behavior change. All participants will attend follow-up visits to assess behavior change at Months 6 and 12 following study entry.
- Conditions
- Depression, Adolescent Health
- Being tested
- Treatment as usual, Behavioral health intervention
- Keywords
- Tobacco Use, Alcohol and Drug Use, Obesity, Risky Sexual Behavior
- Medical subject headings
- Depression, Tobacco Use, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as usualOther
Those participants receiving standard care will be referred to special programs as needed to reduce their involvement in risky health behaviors.
Behavioral health interventionBehavioural
Participants assigned to the health education intervention will attend 10 weekly education sessions that will be led by trained health educators. Parents or guardians may be asked to attend sessions depending on their interest in the intervention and the age of the youth participant. Topics covered will include teenage smoking, alcohol and drug abuse, risky sexual behaviors, and obesity. Cognitive-behavioral strategies, role playing, and media clips will be used to stimulate discussion and involvement in the intervention.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Participants will receive treatment as usual Receives: Other: Treatment as usual |
| 1 | Experimental | Participants will receive the behavioral health intervention Receives: Behavioral: Behavioral health intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite health risk behavior score
Measured: Measured at Months 6 and 12
Secondary outcomes (2)
Composite International Diagnostic Interview (CIDI) depression diagnosis
Measured: Measured at Months 6 and 12
Satisfaction with care, as measured by the SF-12 health survey
Measured: Measured at Months 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startOct 2007
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Kaiser Permanente Research Foundation
- Responsible party
- Principal investigator, Joan Asarnow, University of California, Los Angeles
- Investigators
- Joan Asarnow, PhD, Principal investigator, University of California, Los Angeles, Semel Institute of Neuroscience and Human Behavior
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461539
- Sponsor's protocol ID
- R01MH078596
- Other IDs
- R01MH078596, DAHBR 96-BHB
- Status last verified
- Jun 2013
- First submitted
- 16 Apr 2007
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bai S, Zeledon LR, D'Amico EJ, Shoptaw S, Avina C, LaBorde AP, Anderson M, Fitzpatrick OM, Asarnow JR. Reducing Health Risk Behaviors and Improving Depression in Adolescents: A Randomized Controlled Trial in Primary Care Clinics. J Pediatr Psychol. 2018 Oct 1;43(9):1004-1016. doi: 10.1093/jpepsy/jsy048.
PubMed 30016473Asarnow JR, Zeledon LR, D'Amico E, LaBorde A, Anderson M, Avina C, Arslanian T, Do MC, Harwood J, Shoptaw S. Depression and Health Risk Behaviors: Towards Optimizing Primary Care Service Strategies for Addressing Risk. Prim Health Care. 2014 Mar 1;4(1):152. doi: 10.4172/2167-1079.1000152.
PubMed 25309826
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Health Risk Behavior and Improving Health in Adolescent Depression
- ClinicalTrials.gov ID
- NCT00461539
- Acronym / sponsor ID
- R01MH078596
- Conditions
- Depression, Adolescent Health
- Keywords
- Tobacco Use, Alcohol and Drug Use, Obesity, Risky Sexual Behavior
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Kaiser Permanente Research Foundation
- Study start
- Oct 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 18 Apr 2007 (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.
This study will determine the effectiveness of a health education intervention in reducing health risk behavior and improving health in adolescents with depression.
Detailed description
Depression is a common disorder among adolescents. If left untreated, it can cause significant disability, illness, and even death. Teens with depression often engage in risky health behaviors, such as smoking, drug and alcohol use, unprotected sex, and unhealthy eating and exercise patterns. By reducing these health risk behaviors, depressed adolescents may be able to avoid negative health consequences and improve their physical and mental health. This study will determine the effectiveness of a health education intervention in reducing risky health behaviors in adolescents with depression.
Participants in this study will be invited to enroll during a visit to a participating primary care clinic. Participants will be randomly assigned to either partake in a health education intervention or receive standard care. Both groups will continue to receive treatment through their primary care clinic. Those participants receiving standard care will be referred to special programs as needed to reduce their involvement in risky health behaviors. Participants assigned to the health education intervention will attend 10 weekly education sessions that will be led by trained health educators. Parents or guardians may be asked to attend sessions depending on their interest in the intervention and the age of the youth participant. Topics covered will include teenage smoking, alcohol and drug abuse, risky sexual behaviors, and obesity. Cognitive-behavioral strategies, role playing, and media clips will be used to stimulate discussion and involvement in the intervention. The intervention will be tailored to target the specific risky behaviors in which each participant engages. Motivational interviewing will also be used to build positive attitudes to support behavior change. All participants will attend follow-up visits to assess behavior change at Months 6 and 12 following study entry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Other: Treatment as usualParticipants will receive treatment as usual |
| 1 | Experimental | Behavioral: Behavioral health interventionParticipants will receive the behavioral health intervention |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- CIDI diagnosis of major depression or probable depression based on youth self report
- Availability of a family member to provide informed consent
Key exclusion criteria (6 listed)
- Lacks contact information (e.g., address, telephone number)
- Any functioning deficits or other characteristics that might interfere with study participation
- Currently in a living situation that might interfere with study participation (e.g., lives over 1 hour away from the study site)
- Lacks family available to participate in the intervention
- Mental retardation
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 |
|---|---|---|
| Treatment as usualThose participants receiving standard care will be referred to special programs as needed to reduce their involvement in risky health behaviors. | Other | 2 |
| Behavioral health interventionParticipants assigned to the health education intervention will attend 10 weekly education sessions that will be led by trained health educators. Parents or guardians may be asked to attend sessions depending on their interest in the intervention and the age of the youth participant. Topics covered will include teenage smoking, alcohol and drug abuse, risky sexual behaviors, and obesity. Cognitive-behavioral strategies, role playing, and media clips will be used to stimulate discussion and involvement in the intervention. | Behavioural | 1 |
Primary outcome
Composite health risk behavior score
Time frame: Measured at Months 6 and 12
2 secondary outcomes
Composite International Diagnostic Interview (CIDI) depression diagnosis
Time frame: Measured at Months 6 and 12
Satisfaction with care, as measured by the SF-12 health survey
Time frame: Measured at Months 6 and 12
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 3 Nov 2022.
- Background: PubMed 30016473Bai S, Zeledon LR, D'Amico EJ, Shoptaw S, Avina C, LaBorde AP, Anderson M, Fitzpatrick OM, Asarnow JR. Reducing Health Risk Behaviors and Improving Depression in Adolescents: A Randomized Controlled Trial in Primary Care Clinics. J Pediatr Psychol. 2018 Oct 1;43(9):1004-1016. doi: 10.1093/jpepsy/jsy048.
- Background: PubMed 25309826Asarnow JR, Zeledon LR, D'Amico E, LaBorde A, Anderson M, Avina C, Arslanian T, Do MC, Harwood J, Shoptaw S. Depression and Health Risk Behaviors: Towards Optimizing Primary Care Service Strategies for Addressing Risk. Prim Health Care. 2014 Mar 1;4(1):152. doi: 10.4172/2167-1079.1000152.
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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.
Joan Asarnow, PhD principal investigator
University of California, Los Angeles, Semel Institute of Neuroscience and Human Behavior
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Treatment as usual and Behavioral health intervention in people with Depression and Adolescent Health, run by University of California, Los Angeles at 2 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 2 inclusion and 6 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 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Composite health risk behavior score (time frame: Measured at Months 6 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00461539, which also lists 2 linked publications.
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 3 Nov 2022.