DepressionPhase 1NCT00867919
Designing and Testing a Family Therapy for Adolescent Depression
A Phase 1 study testing Behavioral Family Treatment and Community-based treatment as usual in people with Depression, run by Oregon Research Institute at 2 sites in United States.
Trial summary
This study will design and test a cognitive behavioral therapy for depressed adolescents that uses family interactions to help with treatment. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Depression
- What is being tested?
- Behavioral Family Treatment and Community-based treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2009to Dec 2012
- 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 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Family with an adolescent between 14 and 18 years of age and at least one parent or permanent guardian with whom the adolescent resides
- Family's primary concerns include depressive symptoms
- Adolescent has a score above 24 on the Center for Epidemiological Studies-Depression Scale
- Family will be seeking services at the community mental health center that is associated with the study
Who cannot join
- Adolescents presenting with evidence of severe difficulties associated with comorbid conditions, such that the focus of treatment would need to shift to nonaffective symptoms
- Adolescents evidencing symptoms of mania or psychoses or with suicidal behaviors requiring inpatient care
- Adolescents with cognitive limitations of severity that will preclude meaningful participation in the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Options Counseling
Eugene, Oregon, 97403
Oregon Research Institute
Eugene, Oregon, 97403
About this study
Official title: Family Therapy for Adolescent Depression: Deployment Focused Development, Phase 1
This study will design and test a cognitive behavioral therapy for depressed adolescents that uses family interactions to help with treatment.
Read the detailed description
Adolescent depression causes persistent feelings of sadness, loss of self-worth, discouragement, and loss of interest in usual activities. Treatments for adolescent depression have mixed success, with 25% to 40% of depressed adolescents still experiencing depressive symptoms at the end of the most effective treatments and gains made in treatment sometimes fading over time. Research suggests that family processes are associated with the effectiveness of treatments for adolescent depression and with reducing symptoms over time. Evidence also shows that treatments developed and tested in a research setting are not easily applied to community settings. This study will first design a cognitive behavioral therapy for adolescent depression that will involve the families of the depressed adolescents and then test the therapy in several settings, including clinics.
Development of this therapy will involve five different groups of participants. Each group will include both depressed adolescents and a parent or guardian. The first group of participants will partake in a focus group, in which they will break into two discussion groups, one of parents and guardians and one of adolescents, that will discuss what kind of help and information would be useful to them and why they would consider seeing a therapist.
The second group will participate in alpha testing, which will involve receiving the first version of the therapy. The therapy is anticipated to include 8 to 12 weekly treatment sessions, with homework assignments to practice their learned skills in everyday life. Participants in alpha testing will also complete interviews and questionnaires at Week 7 and at the end of treatment to assess satisfaction with treatment, treatment clarity, and usefulness of the information and strategies they learned. After alpha testing, the therapy will be revised based on the feedback received. The third group will participate in beta testing, which will involve receiving the second version of the therapy and completing the same assessments as those done by the alpha group.
The fourth group of participants will receive pilot testing of the finalized therapy. This finalized version will involve 11 to 15 weekly sessions. The fifth group will receive treatment as usual from a mental health clinic and serve as a control group to compare to the pilot testing group. Before and after treatment, both of these groups will complete questionnaires and interviews assessing the effectiveness of their treatment and questionnaires and observations of family functioning. All sessions throughout the study involving the newly designed family therapy will be videotaped.
- Conditions
- Depression
- Being tested
- Behavioral Family Treatment, Community-based treatment as usual
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Family TreatmentBehavioural
11 to 15 sessions of a cognitive behavioral family therapy that will be developed during the course of this study and will address the following:
- parent-adolescent conflict
- adolescent development
- support and closeness
- behavioral activation
- response to adolescent negative affect
- relapse prevention
- suicide prevention, if necessary
Community-based treatment as usualOther
Treatment as usual, which will most likely consist of 8 to 10 sessions of community-based depression treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive a cognitive behavioral family therapy for adolescent depression to be developed in this study. Receives: Behavioral: Behavioral Family Treatment |
| 2 | Active comparator | Participants will receive treatment as usual 1 year prior to the experimental treatment group. Receives: Other: Community-based treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center for Epidemiological Studies-Depression (CES-D) Scale
Measured: Measured pre- and post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionNov 2012
- Study completionDec 2012
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Lisa B. Sheeber, PhD, Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867919
- Sponsor's protocol ID
- R34MH076966
- Other IDs
- R34MH076966, DDTR B4-TBI
- Status last verified
- Apr 2013
- First submitted
- 23 Mar 2009
- Last updated
- 18 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Therapy for Adolescent Depression: Deployment Focused Development, Phase 1
- ClinicalTrials.gov ID
- NCT00867919
- Acronym / sponsor ID
- R34MH076966
- Conditions
- Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Mar 2009 (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 design and test a cognitive behavioral therapy for depressed adolescents that uses family interactions to help with treatment.
Detailed description
Adolescent depression causes persistent feelings of sadness, loss of self-worth, discouragement, and loss of interest in usual activities. Treatments for adolescent depression have mixed success, with 25% to 40% of depressed adolescents still experiencing depressive symptoms at the end of the most effective treatments and gains made in treatment sometimes fading over time. Research suggests that family processes are associated with the effectiveness of treatments for adolescent depression and with reducing symptoms over time. Evidence also shows that treatments developed and tested in a research setting are not easily applied to community settings. This study will first design a cognitive behavioral therapy for adolescent depression that will involve the families of the depressed adolescents and then test the therapy in several settings, including clinics.
Development of this therapy will involve five different groups of participants. Each group will include both depressed adolescents and a parent or guardian. The first group of participants will partake in a focus group, in which they will break into two discussion groups, one of parents and guardians and one of adolescents, that will discuss what kind of help and information would be useful to them and why they would consider seeing a therapist.
The second group will participate in alpha testing, which will involve receiving the first version of the therapy. The therapy is anticipated to include 8 to 12 weekly treatment sessions, with homework assignments to practice their learned skills in everyday life. Participants in alpha testing will also complete interviews and questionnaires at Week 7 and at the end of treatment to assess satisfaction with treatment, treatment clarity, and usefulness of the information and strategies they learned. After alpha testing, the therapy will be revised based on the feedback received. The third group will participate in beta testing, which will involve receiving the second version of the therapy and completing the same assessments as those done by the alpha group.
The fourth group of participants will receive pilot testing of the finalized therapy. This finalized version will involve 11 to 15 weekly sessions. The fifth group will receive treatment as usual from a mental health clinic and serve as a control group to compare to the pilot testing group. Before and after treatment, both of these groups will complete questionnaires and interviews assessing the effectiveness of their treatment and questionnaires and observations of family functioning. All sessions throughout the study involving the newly designed family therapy will be videotaped.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Behavioral Family TreatmentParticipants will receive a cognitive behavioral family therapy for adolescent depression to be developed in this study. |
| 2 | Active comparator | Other: Community-based treatment as usualParticipants will receive treatment as usual 1 year prior to the experimental treatment group. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Family with an adolescent between 14 and 18 years of age and at least one parent or permanent guardian with whom the adolescent resides
- Family's primary concerns include depressive symptoms
- Adolescent has a score above 24 on the Center for Epidemiological Studies-Depression Scale
- Family will be seeking services at the community mental health center that is associated with the study
Key exclusion criteria (3 listed)
- Adolescents presenting with evidence of severe difficulties associated with comorbid conditions, such that the focus of treatment would need to shift to nonaffective symptoms
- Adolescents evidencing symptoms of mania or psychoses or with suicidal behaviors requiring inpatient care
- Adolescents with cognitive limitations of severity that will preclude meaningful participation in the study
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 |
|---|---|---|
| Behavioral Family Treatment11 to 15 sessions of a cognitive behavioral family therapy that will be developed during the course of this study and will address the following: * parent-adolescent conflict * adolescent development * support and closeness * behavioral activation * response to adolescent negative affect * relapse prevention * suicide prevention, if necessary | Behavioural | 1 |
| Community-based treatment as usualTreatment as usual, which will most likely consist of 8 to 10 sessions of community-based depression treatment | Other | 2 |
Primary outcome
Center for Epidemiological Studies-Depression (CES-D) Scale
Time frame: Measured pre- and post-intervention
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 Apr 2013.
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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.
Lisa B. Sheeber, PhD principal investigator
Oregon Research Institute
2 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 Behavioral Family Treatment and Community-based treatment as usual in people with Depression, run by Oregon Research Institute 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 4 inclusion and 3 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 Apr 2013. 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 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?
Center for Epidemiological Studies-Depression (CES-D) Scale (time frame: Measured pre- and post-intervention). 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 Apr 2013.