Family Based Treatment of Depressed Adolescents (BudFam)
July 30, 2015 updated by: Helse Stavanger HF
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rogaland
-
Stavanger, Rogaland, Norway, 4095
- Department of Child and Adolescent Psychiatry, Stavanger University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Suicidal and require in-patient care
- Low intellectual abilities
- Current psychosis
- primary caregiver unwilling to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Attachment Based Family Therapy (ABFT) ABFT developed by Dr. Guy Diamond and colleagues is a brief, 12 week, manualized family-based intervention. |
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.
Other Names:
|
|
Active Comparator: 2
Treatment as usual (TAU) No attempt is made to standardize TAU. Regular clinical staff will provide mental health services. |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Hamilton Depression Rating scale (HAM-D, 17 items)
Time Frame: Baseline, 6, 12 and 26 weeks
|
Baseline, 6, 12 and 26 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Beck depression Inventory (BDI-II)
Time Frame: Bi-weekly for 12 weeks
|
Bi-weekly for 12 weeks
|
|
Kiddie- SADS (diagnostic interview)
Time Frame: Baseline and 26 weeks
|
Baseline and 26 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Pravin Israel, Ph.D, Stavanger University Hospital, Norway
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
June 13, 2008
First Submitted That Met QC Criteria
June 13, 2008
First Posted (Estimate)
June 18, 2008
Study Record Updates
Last Update Posted (Estimate)
July 31, 2015
Last Update Submitted That Met QC Criteria
July 30, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18651
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.