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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University Hospital, Akershus
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
Helse Sor-Ost
University of Oslo
Information provided by (Responsible Party):
Pravin Israel, University Hospital, Akershus
ClinicalTrials.gov Identifier:
NCT01830088
First received: April 8, 2013
Last updated: October 5, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Depressive Disorder
Mood Disorder
Major Depression
Behavioral: Attachment Based Family Therapy
Behavioral: Enhanced Usual Care
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Family-based Treatment of Depressed Adolescents: An Empirical Study With Norwegian Adolescents in Specialty Mental Health Care

Resource links provided by NLM:


Further study details as provided by University Hospital, Akershus:

Primary Outcome Measures:
  • Change from baseline in Hamilton Depression Rating scale [ Time Frame: 12, 24 and 48 weeks ] [ Designated as safety issue: No ]
    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:
  • Beck depression Inventory (BDI-II) [ Time Frame: Bi-weekly for 12 weeks, and at week 24 and week 48 ] [ Designated as safety issue: No ]
  • Kiddie-SADS (Diagnostic interview) [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Change from baseline in Conflict Behavior Questionnaire [ Time Frame: Biweekly for 12 weeks and week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: EUC

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01830088

Contacts
Contact: Pravin Israel, PhD +4748029628 kpravin@mac.com

Locations
Norway
Akershus University Hospital Recruiting
Lorenskog, Akershus, Norway, 1478
Contact: Pravin Israel, PhD    +4748029628    kpravin@mac.com   
Principal Investigator: Pravin Israel, PhD         
Sponsors and Collaborators
University Hospital, Akershus
Children's Hospital of Philadelphia
Helse Sor-Ost
University of Oslo
Investigators
Principal Investigator: Pravin Israel, PhD University Hospital, Akershus
  More Information

Publications:
Responsible Party: Pravin Israel, Senior research/ Associate Professor, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT01830088     History of Changes
Other Study ID Numbers: BudFam2
Study First Received: April 8, 2013
Last Updated: October 5, 2013
Health Authority: Norway: Regional Ethics Commitee

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Behavioral Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014