Family Based Treatment of Depressed Adolescents (AHUS)

NCT01830088 | Terminated DMC

• 1 other identifier: BudFam2
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder; Mood Disorder; Major Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Outcomes (1)

• Change from baseline in Conflict Behavior Questionnaire

  Biweekly for 12 weeks and week 24

Study Arms (2)

Attachment Based Family Therapy

EXPERIMENTAL

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

Enhanced Usual Care

ACTIVE COMPARATOR

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

Behavioral: Enhanced Usual Care

Interventions

Attachment Based Family Therapy BEHAVIORAL

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

Also known as: ABFT

Attachment Based Family Therapy

Enhanced Usual Care BEHAVIORAL

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

Also known as: EUC

Enhanced Usual Care

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Akershus: lead
• Children's Hospital of Philadelphia: collaborator
• Helse Sor-Ost: collaborator
• University of Oslo: collaborator

Study Sites (1)

Akershus University Hospital

Lorenskog, Akershus, 1478, Norway

Location

Related Publications (2)

• 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.

  PMID: 22930777 BACKGROUND

• 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.

  PMID: 33579332 DERIVED

MeSH Terms

Conditions

Depressive Disorder; Mood Disorders; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Marianne A Villabø, PhD

  University Hospital, Akershus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessors (HAM-D) are masked and do not know the treatment arm of the participant
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: The two treatment arms are i) Attachment Based Family Therapy and ii) Treatment as usual

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 12, 2013
• Study Start: October 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

NO (1)