Family Based Treatment of Depressed Adolescents (AHUS)

Not Applicable

Terminated

• Conditions: Major Depression; Depressive Disorder; Mood Disorder
• Interventions: Behavioral: Attachment Based Family Therapy; Behavioral: Enhanced Usual Care

• Registration Number: NCT01830088
• Lead Sponsor: University Hospital, Akershus

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-08
• Study First Submitted QC: 2013-04-11
• Study First Posted: 2013-04-12
• Study Start: 2013-10
• Primary Completion: 2016-01
• Study Completion: 2016-06
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-04
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Attachment Based Family Therapy	Attachment Based Family Therapy	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
Enhanced Usual Care	Enhanced Usual Care	No attempt is made to control any aspect of the enhanced usual care except for pre-scheduled assessment plan

Primary Outcome Measures

Name	Time	Method
Change from baseline in Hamilton Depression Rating scale	12, 24 and 48 weeks	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

Name	Time	Method
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

Trial Locations

Locations (1)

Akershus University Hospital; 🇳🇴 Lorenskog, Akershus, Norway