Depressive DisorderPhase 2BudFamNCT00700609
Family Based Treatment of Depressed Adolescents
A Phase 2 study testing Attachment Based Family therapy (ABFT) in people with Depressive Disorder and Mood Disorder, run by Helse Stavanger HF at 1 site in Norway.
Trial summary
The purpose of this project is to assess the effectiveness of a family-based therapy (Attachment based family therapy-ABFT) for Norwegian adolescents (13-17 years) referred to specialist mental heath clinics. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Depressive Disorder, Mood Disorder, Major Depression
- What is being tested?
- Attachment Based Family therapy (ABFT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2008to Dec 2009
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 13-17 years
- Referred to specialist mental health hospital
- HAM-D score of >14
- Meets diagnostic criteria for major depressive disorder or depression NOS
- Have a parent or guardian willing to participate
Who cannot join
- Suicidal and require in-patient care
- Low intellectual abilities
- Current psychosis
- primary caregiver unwilling to participate
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Child and Adolescent Psychiatry, Stavanger University Hospital
Stavanger, Rogaland, 4095
About this study
Official title: Family-Based Treatment of Depressed Adolescents: An Empirical Study With Norwegian Adolescents in Specialty Mental Health Care
The purpose of this project is to assess the effectiveness of a family-based therapy (Attachment based family therapy-ABFT) for Norwegian adolescents (13-17 years) referred to specialist mental heath clinics.
Read the detailed description
Depression is a major public health concern among adolescents. Research suggests that it not only is prevalent among adolescents (as many as 20% of adolescents have a depressive episode by the age of 18), but its effects last well into adulthood. Although available studies of psychosocial and pharmacological interventions show promise, there are concerns regarding their effectiveness and possible side effects like increase in suicidal ideation. Family conflict is not only an effect of depression, but also a risk factor for depression. High conflict and dysfunction, have consistently been shown to increase risk for depression. As such, family treatments that target risk and protective factors (e.g., quality of parent-child interaction, parental monitoring) for depression seem promising to reduce depression. The current study is a randomized clinical trail aimed at assessing the effectiveness of a 12-week family based intervention for depressed adolescents (Attachment based family therapy- ABFT). Adolescents referred to specialist mental health hospital in south-west Norway (Stavanger University Hospital) will be randomized to either ABFT or treatment as usual (TAU). Therapists administering both the experimental and control group intervention are regular staff clinicians. Outcome assessments would be carried out at baseline, 6, 12 and 26 weeks by raters blind to the condition of the treatment.
- Conditions
- Depressive Disorder, Mood Disorder, Major Depression
- Being tested
- Attachment Based Family therapy (ABFT)
- Keywords
- Depression, Family Therapy, Adolescents
- Medical subject headings
- Depressive Disorder, Mood Disorders, Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attachment Based Family therapy (ABFT)Behavioural
Also called ABFT, TAU
Attachment-Based Family Therapy (ABFT) is a brief manualized therapy designed exclusively for depressed adolescents and aims at reducing adolescent depression by improving family communication and trust.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Attachment Based Family Therapy (ABFT)
ABFT developed by Dr. Guy Diamond and colleagues is a brief, 12 week, manualized family-based intervention. Receives: Behavioral: Attachment Based Family therapy (ABFT) |
| 2 | Active comparator | Treatment as usual (TAU)
No attempt is made to standardize TAU. Regular clinical staff will provide mental health services. Receives: Behavioral: Attachment Based Family therapy (ABFT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating scale (HAM-D, 17 items)
Measured: Baseline, 6, 12 and 26 weeks
Secondary outcomes (2)
Beck depression Inventory (BDI-II)
Measured: Bi-weekly for 12 weeks
Kiddie- SADS (diagnostic interview)
Measured: Baseline and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionMar 2009
- Study completionDec 2009
Why it stopped: The PI moved to another city and position
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- The Research Council of Norway
- Responsible party
- Sponsor
- Investigators
- Pravin Israel, Ph.D, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700609
- Sponsor's protocol ID
- 18651
- Acronym
- BudFam
- Status last verified
- Jul 2015
- First submitted
- 13 Jun 2008
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Based Treatment of Depressed Adolescents: An Empirical Study With Norwegian Adolescents in Specialty Mental Health Care
- ClinicalTrials.gov ID
- NCT00700609
- Acronym / sponsor ID
- BudFam / 18651
- Conditions
- Depressive Disorder, Mood Disorder, Major Depression
- Keywords
- Depression, Family Therapy, Adolescents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The PI moved to another city and position
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- The Research Council of Norway
- Study start
- Jun 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 18 Jun 2008 (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 purpose of this project is to assess the effectiveness of a family-based therapy (Attachment based family therapy-ABFT) for Norwegian adolescents (13-17 years) referred to specialist mental heath clinics.
Detailed description
Depression is a major public health concern among adolescents. Research suggests that it not only is prevalent among adolescents (as many as 20% of adolescents have a depressive episode by the age of 18), but its effects last well into adulthood. Although available studies of psychosocial and pharmacological interventions show promise, there are concerns regarding their effectiveness and possible side effects like increase in suicidal ideation. Family conflict is not only an effect of depression, but also a risk factor for depression. High conflict and dysfunction, have consistently been shown to increase risk for depression. As such, family treatments that target risk and protective factors (e.g., quality of parent-child interaction, parental monitoring) for depression seem promising to reduce depression. The current study is a randomized clinical trail aimed at assessing the effectiveness of a 12-week family based intervention for depressed adolescents (Attachment based family therapy- ABFT). Adolescents referred to specialist mental health hospital in south-west Norway (Stavanger University Hospital) will be randomized to either ABFT or treatment as usual (TAU). Therapists administering both the experimental and control group intervention are regular staff clinicians. Outcome assessments would be carried out at baseline, 6, 12 and 26 weeks by raters blind to the condition of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Attachment Based Family therapy (ABFT)Attachment Based Family Therapy (ABFT) ABFT developed by Dr. Guy Diamond and colleagues is a brief, 12 week, manualized family-based intervention. |
| 2 | Active comparator | Behavioral: Attachment Based Family therapy (ABFT)Treatment as usual (TAU) No attempt is made to standardize TAU. Regular clinical staff will provide mental health services. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 13-17 years
- Referred to specialist mental health hospital
- HAM-D score of >14
- Meets diagnostic criteria for major depressive disorder or depression NOS
- Have a parent or guardian willing to participate
Key exclusion criteria (4 listed)
- Suicidal and require in-patient care
- Low intellectual abilities
- 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 (ABFT)Also: ABFT, TAUAttachment-Based Family Therapy (ABFT) is a brief manualized therapy designed exclusively for depressed adolescents and aims at reducing adolescent depression by improving family communication and trust. | Behavioural | 1, 2 |
Primary outcome
Hamilton Depression Rating scale (HAM-D, 17 items)
Time frame: Baseline, 6, 12 and 26 weeks
2 secondary outcomes
Beck depression Inventory (BDI-II)
Time frame: Bi-weekly for 12 weeks
Kiddie- SADS (diagnostic interview)
Time frame: Baseline and 26 weeks
Results and safety
The study was stopped early (reason given: The PI moved to another city and position). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
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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.
Pravin Israel, Ph.D principal investigator
Helse Stavanger HF
1 site 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 (ABFT) in people with Depressive Disorder and Mood Disorder, run by Helse Stavanger HF at 1 site in Norway.
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 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 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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: The PI moved to another city and position). 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?
Hamilton Depression Rating scale (HAM-D, 17 items) (time frame: Baseline, 6, 12 and 26 weeks). 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 31 Jul 2015.