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

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

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.

Study Overview

• Status: Terminated
• Conditions: Depressive Disorder; Major Depression; Mood Disorder
• Intervention / Treatment: Behavioral: Attachment Based Family Therapy; Behavioral: Enhanced Usual Care

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Akershus
    • Lorenskog, Akershus, Norway, 1478
      • Akershus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Behavioral: Attachment Based Family Therapy; 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; Other Names: ABFT
ACTIVE_COMPARATOR: Enhanced Usual Care; No attempt is made to control any aspect of the enhanced usual care except for pre-scheduled assessment plan	Behavioral: Enhanced Usual Care; No attempt is made to control any aspect of the enhanced usual care except for pre-scheduled assessment plan; Other Names: EUC

What is the study measuring?

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	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

Other Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Conflict Behavior Questionnaire	Biweekly for 12 weeks and week 24

Collaborators and Investigators

• Sponsor: University Hospital, Akershus
• Collaborators: University of Oslo; Children's Hospital of Philadelphia; Helse Sor-Ost
• Investigators: Principal Investigator: Marianne A Villabø, PhD, University Hospital, Akershus

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): January 1, 2016
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: April 8, 2013
• First Submitted That Met QC Criteria: April 11, 2013
• First Posted (ESTIMATE): April 12, 2013

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 4, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Depressive Disorder; Disease; Mood Disorders
• Other Study ID Numbers: BudFam2