Family Based Treatment of Depressed Adolescents (AHUS) (BudFam2)

University Hospital, Akershus

Status: Terminated

Conditions: Major Depression; Mood Disorder; Depressive Disorder

Treatments: Behavioral: Attachment Based Family Therapy; Behavioral: Enhanced Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT01830088

BudFam2

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Attachment Based Family Therapy

Experimental group

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

Treatment:

Behavioral: Attachment Based Family Therapy

Enhanced Usual Care

Active Comparator group

Description:

No attempt is made to control any aspect of the enhanced usual care except for pre-scheduled assessment plan

Treatment:

Behavioral: Enhanced Usual Care