Family Based Treatment of Depressed Adolescents (BudFam)
Primary Purpose
Depressive Disorder, Mood Disorder, Major Depression
Status
Terminated
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Attachment Based Family therapy (ABFT)
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder focused on measuring Depression, Family Therapy, Adolescents
Eligibility Criteria
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
Sites / Locations
- Department of Child and Adolescent Psychiatry, Stavanger University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Attachment Based Family Therapy (ABFT) ABFT developed by Dr. Guy Diamond and colleagues is a brief, 12 week, manualized family-based intervention.
Treatment as usual (TAU) No attempt is made to standardize TAU. Regular clinical staff will provide mental health services.
Outcomes
Primary Outcome Measures
Hamilton Depression Rating scale (HAM-D, 17 items)
Secondary Outcome Measures
Beck depression Inventory (BDI-II)
Kiddie- SADS (diagnostic interview)
Full Information
NCT ID
NCT00700609
First Posted
June 13, 2008
Last Updated
July 30, 2015
Sponsor
Helse Stavanger HF
Collaborators
The Research Council of Norway
1. Study Identification
Unique Protocol Identification Number
NCT00700609
Brief Title
Family Based Treatment of Depressed Adolescents
Acronym
BudFam
Official Title
Family-Based Treatment of Depressed Adolescents: An Empirical Study With Norwegian Adolescents in Specialty Mental Health Care
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
The PI moved to another city and position
Study Start Date
June 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Stavanger HF
Collaborators
The Research Council of Norway
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Mood Disorder, Major Depression
Keywords
Depression, Family Therapy, Adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Attachment Based Family Therapy (ABFT)
ABFT developed by Dr. Guy Diamond and colleagues is a brief, 12 week, manualized family-based intervention.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Treatment as usual (TAU)
No attempt is made to standardize TAU. Regular clinical staff will provide mental health services.
Intervention Type
Behavioral
Intervention Name(s)
Attachment Based Family therapy (ABFT)
Other Intervention Name(s)
ABFT, TAU
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hamilton Depression Rating scale (HAM-D, 17 items)
Time Frame
Baseline, 6, 12 and 26 weeks
Secondary Outcome Measure Information:
Title
Beck depression Inventory (BDI-II)
Time Frame
Bi-weekly for 12 weeks
Title
Kiddie- SADS (diagnostic interview)
Time Frame
Baseline and 26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pravin Israel, Ph.D
Organizational Affiliation
Stavanger University Hospital, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Child and Adolescent Psychiatry, Stavanger University Hospital
City
Stavanger
State/Province
Rogaland
ZIP/Postal Code
4095
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Family Based Treatment of Depressed Adolescents
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