Family Based Treatment of Depressed Adolescents (AHUS)

Study Overview
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Brief Summary
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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.

Official Title
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Family-based Treatment of Depressed Adolescents: An Empirical Study With Norwegian Adolescents in Specialty Mental Health Care

Conditions
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Depressive Disorder, Mood Disorder, Major Depression

Intervention / Treatment
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* Behavioral: Attachment Based Family Therapy
* Behavioral: Enhanced Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The two treatment arms are i) Attachment Based Family Therapy and ii) Treatment as usual
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Attachment Based Family Therapy<br>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 | Behavioral: Attachment Based Family Therapy<br>* 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<br>* Other names: ABFT;|
| Active Comparator: Enhanced Usual Care<br>No attempt is made to control any aspect of the enhanced usual care except for pre-scheduled assessment plan | Behavioral: Enhanced Usual Care<br>* No attempt is made to control any aspect of the enhanced usual care except for pre-scheduled assessment plan<br>* Other names: EUC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12, 24 and 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck depression Inventory (BDI-II) |  | Bi-weekly for 12 weeks, and at week 24 and week 48 | 
| Kiddie-SADS (Diagnostic interview) |  | Baseline and 26 weeks |