DepressionPhase 2NCT00329199
Pennsylvania Adolescent Intervention Research Study (PAIRStudy)
A Phase 2 study testing Attachment-Based Family Therapy in people with Depression, run by Pennsylvania Department of Health at 3 sites in United States.
Trial summary
Through the TRIAD Project: Pennsylvania Adolescent Intervention Research Study (PAIRStudy; Project 3a) we aim to test the efficacy of a brief treatment aimed at treating depression and family conflict among a population of adolescents with depression, and thereby reducing the future chance of these adolescents… Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Attachment-Based Family Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 240 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2006to May 2007
- Phase
- Phase 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 12 to 17 years of age
- HAM-D score of > 14
- Meet diagnostic criteria for either Major Depressive Disorder, Dysthymia, or Depression NOS
- Have a parent or guardian willing to participate
Who cannot join
- Currently Suicidal
- History of mental retardation or borderline intellectual functioning
- Current psychosis
- Primary caregiver unwilling to participate
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18104
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
The Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: TRIAD Project: Pennsylvania Adolescent Intervention Research Study (PAIRStudy; Project 3a)
Through the TRIAD Project: Pennsylvania Adolescent Intervention Research Study (PAIRStudy; Project 3a) we aim to test the efficacy of a brief treatment aimed at treating depression and family conflict among a population of adolescents with depression, and thereby reducing the future chance of these adolescents initiating smoking. We will examine Attachment-Based Family Therapy (ABFT) for the treatment of depression in comparison with Enhanced Usual Care for Depression (EUCd). Reduction of depression will be measured by a clinically significant reduction of score on the Hamilton Rating Scale for Depression. Second, we will examine how reduction of family conflict mediates the effect of ABFT on depression. The third aim will be an exploratory look at the potential prevention of the onset of smoking. Specifically, we will examine if reduction of depression and/or reductions in family conflict regardless of treatment type reduces the initiation of smoking or reduces smoking behavior at 52 weeks. These aims will be accomplished by randomizing 240 adolescents to one of two treatment conditions: a) Attachment-Based Family Therapy or b) Enhanced Usual Care for Depression. Patients randomized to the ABFT condition will receive 6-12 weeks of family therapy. Patients enrolled in the EUCd condition will be referred for outpatient psychological services at an agency that fits their geographic and financial needs. Research staff will help patients navigate the referral process. All participating therapists will have carried out the full, manualized treatment with 2-3 pilot cases prior to treating any randomized cases.
Read the detailed description
The TRIAD project aims to address the persistent and acute problem of depression in a population largely made up of low-income disadvantaged youth. There are numerous treatment studies available for depression, but few exist studying the treatment of depression via the reduction of family conflict. Through this clinical trial, we aim to investigate the efficacy of a treatment for depression for adolescents largely recruited through primary care. The primary aim of this study is to test whether Attachment-Based Family Therapy reduces depression more effectively than enhanced usual care for depression. Attachment-Based Family Therapy (ABFT) is a manualized therapy designed exclusively for anxious and depressed adolescents. Secondly, we intend to examine how reduction in family conflict mediates the effect of ABFT on depression. We will, furthermore, examine whether reduction in depression or reduction in family conflict, regardless of treatment type reduces the likelihood of smoking initiation at one year.
These aims will be accomplished through a randomized clinical trial of 240 adolescents who meet criteria for a DSM-IV depressive disorder (Major Depressive Disorder, Dysthymia, or Depression NOS). Participants will be randomized into one of two treatment conditions. The two treatment conditions are as follows: Attachment-based Family Therapy for depression or Enhanced Usual Care for Depression. Treatment for Attachment-Based Family Therapy includes anywhere from 6-12 sessions. Some of the 6-12 sessions will include the patient and or the parent meeting alone with the therapists, others will include the family meeting together for family therapy sessions. The Enhanced Usual Care condition will include referrals to outside counseling or therapy, and the number of sessions will vary by patient and practitioner desire. In addition to their treatment sessions, patients and their parents will be required to complete intake, 6-week, 12-week, 26-week, and 52-week assessments. These assessments will include a large battery of self-report measures covering numerous topics around family conflict, risk-taking behavior (including smoking) and depression. The intake, 12, 26 and 52 week assessments will include a diagnostic interview. Additionally, bi-weekly for 12 weeks, adolescent's will be asked to complete a brief set of questionnaires that will help monitor their progress and safety.
- Conditions
- Depression
- Being tested
- Attachment-Based Family Therapy
- Keywords
- Depression, Adolescents, Family Therapy, Primary Care, Family Conflict
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attachment-Based Family TherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in depression as measured by the Hamilton Depression Rating Scale-17.
Secondary outcomes (1)
Smoking initiation or cessation at week 52, as measured by the Timeline Follow-Back.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2006 (estimated)
- Study startDec 2006
- Study completionMay 2007
Why it stopped: Trial was rewritten and will no longer focus on the link between smoking and depression.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pennsylvania Department of Health
- Sponsor type
- Other government
- Collaborators
- Children's Hospital of Philadelphia, University of Pittsburgh, Lehigh Valley Hospital
- Investigators
- Guy S Diamond, Ph.D., Principal investigator, The Children's Hospital of Philadelphia/ University of PennsylvaniaDonald Schwarz, M.D., Principal investigator, Children's Hospital of PhiladelphiaSuzanne A Levy, Ph.D., Study director, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329199
- Sponsor's protocol ID
- SAP#4100027295
- Status last verified
- Aug 2007
- First submitted
- 22 May 2006
- Last updated
- 20 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRIAD Project: Pennsylvania Adolescent Intervention Research Study (PAIRStudy; Project 3a)
- ClinicalTrials.gov ID
- NCT00329199
- Acronym / sponsor ID
- SAP#4100027295
- Conditions
- Depression
- Keywords
- Depression, Adolescents, Family Therapy, Primary Care, Family Conflict
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial was rewritten and will no longer focus on the link between smoking and depression.
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Pennsylvania Department of HealthOther government
- Collaborators
- Children's Hospital of Philadelphia, University of Pittsburgh, Lehigh Valley Hospital
- Study start
- Dec 2006
- Study completion
- May 2007 (actual)
- First posted
- 24 May 2006 (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.
Through the TRIAD Project: Pennsylvania Adolescent Intervention Research Study (PAIRStudy; Project 3a) we aim to test the efficacy of a brief treatment aimed at treating depression and family conflict among a population of adolescents with depression, and thereby reducing the future chance of these adolescents initiating smoking. We will examine Attachment-Based Family Therapy (ABFT) for the treatment of depression in comparison with Enhanced Usual Care for Depression (EUCd). Reduction of depression will be measured by a clinically significant reduction of score on the Hamilton Rating Scale for Depression. Second, we will examine how reduction of family conflict mediates the effect of ABFT on depression. The third aim will be an exploratory look at the potential prevention of the onset of smoking. Specifically, we will examine if reduction of depression and/or reductions in family conflict regardless of treatment type reduces the initiation of smoking or reduces smoking behavior at 52 weeks. These aims will be accomplished by randomizing 240 adolescents to one of two treatment conditions: a) Attachment-Based Family Therapy or b) Enhanced Usual Care for Depression. Patients randomized to the ABFT condition will receive 6-12 weeks of family therapy. Patients enrolled in the EUCd condition will be referred for outpatient psychological services at an agency that fits their geographic and financial needs. Research staff will help patients navigate the referral process. All participating therapists will have carried out the full, manualized treatment with 2-3 pilot cases prior to treating any randomized cases.
Detailed description
The TRIAD project aims to address the persistent and acute problem of depression in a population largely made up of low-income disadvantaged youth. There are numerous treatment studies available for depression, but few exist studying the treatment of depression via the reduction of family conflict. Through this clinical trial, we aim to investigate the efficacy of a treatment for depression for adolescents largely recruited through primary care. The primary aim of this study is to test whether Attachment-Based Family Therapy reduces depression more effectively than enhanced usual care for depression. Attachment-Based Family Therapy (ABFT) is a manualized therapy designed exclusively for anxious and depressed adolescents. Secondly, we intend to examine how reduction in family conflict mediates the effect of ABFT on depression. We will, furthermore, examine whether reduction in depression or reduction in family conflict, regardless of treatment type reduces the likelihood of smoking initiation at one year.
These aims will be accomplished through a randomized clinical trial of 240 adolescents who meet criteria for a DSM-IV depressive disorder (Major Depressive Disorder, Dysthymia, or Depression NOS). Participants will be randomized into one of two treatment conditions. The two treatment conditions are as follows: Attachment-based Family Therapy for depression or Enhanced Usual Care for Depression. Treatment for Attachment-Based Family Therapy includes anywhere from 6-12 sessions. Some of the 6-12 sessions will include the patient and or the parent meeting alone with the therapists, others will include the family meeting together for family therapy sessions. The Enhanced Usual Care condition will include referrals to outside counseling or therapy, and the number of sessions will vary by patient and practitioner desire. In addition to their treatment sessions, patients and their parents will be required to complete intake, 6-week, 12-week, 26-week, and 52-week assessments. These assessments will include a large battery of self-report measures covering numerous topics around family conflict, risk-taking behavior (including smoking) and depression. The intake, 12, 26 and 52 week assessments will include a diagnostic interview. Additionally, bi-weekly for 12 weeks, adolescent's will be asked to complete a brief set of questionnaires that will help monitor their progress and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 12 to 17 years of age
- HAM-D score of > 14
- Meet diagnostic criteria for either Major Depressive Disorder, Dysthymia, or Depression NOS
- Have a parent or guardian willing to participate
Key exclusion criteria (4 listed)
- Currently Suicidal
- History of mental retardation or borderline intellectual functioning
- Current psychosis
- Primary caregiver unwilling to participate
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 |
|---|---|---|
| Attachment-Based Family Therapy | Behavioural | – |
Primary outcome
Reduction in depression as measured by the Hamilton Depression Rating Scale-17.
1 secondary outcome
Smoking initiation or cessation at week 52, as measured by the Timeline Follow-Back.
Results and safety
The study was stopped early (reason given: Trial was rewritten and will no longer focus on the link between smoking and depression.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2007.
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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.
Guy S Diamond, Ph.D. principal investigator
The Children's Hospital of Philadelphia/ University of Pennsylvania
Donald Schwarz, M.D. principal investigator
Children's Hospital of Philadelphia
Suzanne A Levy, Ph.D. study director
Children's Hospital of Philadelphia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Attachment-Based Family Therapy in people with Depression, run by Pennsylvania Department of Health at 3 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 4 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: stopped early, as of the sponsor's last update on 20 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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 was stopped early (reason given: Trial was rewritten and will no longer focus on the link between smoking and depression.). Results are not available in the source record.
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?
Reduction in depression as measured by the Hamilton Depression Rating Scale-17.. 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 20 Aug 2007.