Family Based Treatment of Depressed Adolescents (AHUS) (BudFam2)
Primary Purpose
Depressive Disorder, Mood Disorder, Major Depression
Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Attachment Based Family Therapy
Enhanced Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder
Eligibility Criteria
Inclusion criteria:
- Adolescents between ages 13-17 years
- Adolescents endorsing depression symptoms (HAM-D ≥ 16) on the HAM-D
- Adolescents meet diagnostic criteria for major depressive disorder (MDD) as assessed by Kiddie SADS
- At least one primary parent or caregiver must participate in the assessment and treatment
Exclusion criteria:
- psychotic disorder
- anorexia nervosa
- severe substance dependence disorders
- mental retardation (IQ less than 70 as assessed by the clinician)
- asperger syndrome/autism as assessed by the K-SADS
- Adolescents taking antidepressant medication for depression for less than 6 weeks prior to the screening
Sites / Locations
- Akershus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Attachment Based Family Therapy
Enhanced Usual Care
Arm Description
Attachment-Based Family Therapy (ABFT) is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors
No attempt is made to control any aspect of the enhanced usual care except for pre-scheduled assessment plan
Outcomes
Primary Outcome Measures
Change from baseline in Hamilton Depression Rating scale
The Hamilton Depression Rating Scale (17 item) version is a 17-item, semi-structured interview and is currently a widely used clinical measure depression. Grid HamD (Williams 2008) version is used.
Secondary Outcome Measures
Beck depression Inventory (BDI-II)
Kiddie-SADS (Diagnostic interview)
Full Information
NCT ID
NCT01830088
First Posted
April 8, 2013
Last Updated
May 4, 2018
Sponsor
University Hospital, Akershus
Collaborators
Children's Hospital of Philadelphia, Helse Sor-Ost, University of Oslo
1. Study Identification
Unique Protocol Identification Number
NCT01830088
Brief Title
Family Based Treatment of Depressed Adolescents (AHUS)
Acronym
BudFam2
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
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Funding period expired before reaching recruitment goal.
Study Start Date
October 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Akershus
Collaborators
Children's Hospital of Philadelphia, Helse Sor-Ost, University of Oslo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Major depressive disorder (MDD) affects about 5% of adolescents and is on the rise both internationally and in Norway. Further, it is also associated with increased risk for suicide. Not surprisingly, depression is the largest reason for referral to specialty mental health services for adolescents (13-17 years) in Norway. Although anti-depressants and Cognitive behavioral therapy are strong treatments and have received extensive research, the best treatments show a recovery rate of only 37 %.
There is a need to develop and test alternative treatments that can stand alone or augment anti-depressant medication. Family factors play an important role in the etiology, maintenance and relapse of depression. A promising family-based treatment (Attachment based family therapy- ABFT) was imported to Norway and its feasibility tested in a pilot randomized clinical trial with 20 families. The results showed promising treatment outcomes. Although the developers of the model have refined, adapted the model to suicidal ideation and built strong technology to support dissemination, a definitive study of ABFT for adolescents with major depression has not yet been conducted. Therefore the primary aim of this study is to test if ABFT is more effective that enhanced usual care (EUC) to treat clinic-referred adolescents with major depression. The investigators will test the hypothesis that 12 weeks of ABFT therapy will produce a greater proportion of adolescents report remission from depression and symptom change than 12 weeks of enhanced clinical care (EUC). Secondary research aims are i) to test a hypothesis that parent-adolescent conflict will be more sensitive to change for adolescents receiving ABFT that adolescents receiving EUC ii) to explore patterns of change in suicidal ideation in the recruited sample in the acute-phase treatment.
Central challenges to the study are i) blinding therapists/patients, which is difficult in psychotherapy trials ii) lack of a standardized control condition, and iii) selecting and training regular staff therapists to high adherence levels. However, with tighter control over these factors than is normal for a typical effectiveness trial, the investigators expect results to show what to expect under the "best of conditions" in community clinics. Benchmark derived from the study will inform how to effectively train therapists and subsequently implement the model into mainstream services.
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The two treatment arms are i) Attachment Based Family Therapy and ii) Treatment as usual
Masking
Outcomes Assessor
Masking Description
The outcome assessors (HAM-D) are masked and do not know the treatment arm of the participant
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Attachment Based Family Therapy
Arm Type
Experimental
Arm Description
Attachment-Based Family Therapy (ABFT) is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors
Arm Title
Enhanced Usual Care
Arm Type
Active Comparator
Arm Description
No attempt is made to control any aspect of the enhanced usual care except for pre-scheduled assessment plan
Intervention Type
Behavioral
Intervention Name(s)
Attachment Based Family Therapy
Other Intervention Name(s)
ABFT
Intervention Description
Attachment-Based Family Therapy (ABFT) is is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care
Other Intervention Name(s)
EUC
Intervention Description
No attempt is made to control any aspect of the enhanced usual care except for pre-scheduled assessment plan
Primary Outcome Measure Information:
Title
Change from baseline in Hamilton Depression Rating scale
Description
The Hamilton Depression Rating Scale (17 item) version is a 17-item, semi-structured interview and is currently a widely used clinical measure depression. Grid HamD (Williams 2008) version is used.
Time Frame
12, 24 and 48 weeks
Secondary Outcome Measure Information:
Title
Beck depression Inventory (BDI-II)
Time Frame
Bi-weekly for 12 weeks, and at week 24 and week 48
Title
Kiddie-SADS (Diagnostic interview)
Time Frame
Baseline and 26 weeks
Other Pre-specified Outcome Measures:
Title
Change from baseline in Conflict Behavior Questionnaire
Time Frame
Biweekly for 12 weeks and week 24
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:
Adolescents between ages 13-17 years
Adolescents endorsing depression symptoms (HAM-D ≥ 16) on the HAM-D
Adolescents meet diagnostic criteria for major depressive disorder (MDD) as assessed by Kiddie SADS
At least one primary parent or caregiver must participate in the assessment and treatment
Exclusion criteria:
psychotic disorder
anorexia nervosa
severe substance dependence disorders
mental retardation (IQ less than 70 as assessed by the clinician)
asperger syndrome/autism as assessed by the K-SADS
Adolescents taking antidepressant medication for depression for less than 6 weeks prior to the screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne A Villabø, PhD
Organizational Affiliation
University Hospital, Akershus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akershus University Hospital
City
Lorenskog
State/Province
Akershus
ZIP/Postal Code
1478
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
22930777
Citation
Israel P, Diamond GS. Feasibility of Attachment Based Family Therapy for depressed clinic-referred Norwegian adolescents. Clin Child Psychol Psychiatry. 2013 Jul;18(3):334-50. doi: 10.1177/1359104512455811. Epub 2012 Aug 28.
Results Reference
background
PubMed Identifier
33579332
Citation
Waraan L, Rognli EW, Czajkowski NO, Aalberg M, Mehlum L. Effectiveness of attachment-based family therapy compared to treatment as usual for depressed adolescents in community mental health clinics. Child Adolesc Psychiatry Ment Health. 2021 Feb 12;15(1):8. doi: 10.1186/s13034-021-00361-x.
Results Reference
derived
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Family Based Treatment of Depressed Adolescents (AHUS)
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