Family Based Treatment of Depressed Adolescents (AHUS)

NCT ID: NCT01830088

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Attachment Based Family Therapy

Intervention Type: 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

Enhanced Usual Care

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

Group Type: ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Enhanced Usual Care

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

Intervention Type: BEHAVIORAL

Other Intervention Names

ABFT; EUC

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: collaborator

Helse Sor-Ost

OTHER_GOV

Sponsor Role: collaborator

University of Oslo

OTHER

Sponsor Role: collaborator

University Hospital, Akershus

OTHER

Sponsor Role: lead

Responsible Party

Marianne Villabo

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marianne A Villabø, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Akershus

Locations

Akershus University Hospital

Lorenskog, Akershus, Norway

Countries

Norway

References

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.

Reference Type: BACKGROUND

PMID: 22930777 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33579332 (View on PubMed)

Other Identifiers

BudFam2

Identifier Type: -

Identifier Source: org_study_id