Family Based Treatment of Depressed Adolescents (BudFam)

This study has been terminated.
(The PI moved to another city and position)
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by:
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT00700609
First received: June 13, 2008
Last updated: September 17, 2009
Last verified: September 2009
  Purpose

The purpose of this project is to assess the effectiveness of a family-based therapy (Attachment based family therapy-ABFT) for Norwegian adolescents (13-17 years) referred to specialist mental heath clinics.


Condition Intervention Phase
Depressive Disorder
Mood Disorder
Major Depression
Behavioral: Attachment Based Family therapy (ABFT)
Phase 2

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 Helse Stavanger HF:

Primary Outcome Measures:
  • Hamilton Depression Rating scale (HAM-D, 17 items) [ Time Frame: Baseline, 6, 12 and 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Beck depression Inventory (BDI-II) [ Time Frame: Bi-weekly for 12 weeks ] [ Designated as safety issue: No ]
  • Kiddie- SADS (diagnostic interview) [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: June 2008
Estimated Study Completion Date: December 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

Attachment Based Family Therapy (ABFT)

ABFT developed by Dr. Guy Diamond and colleagues is a brief, 12 week, manualized family-based intervention.

Behavioral: Attachment Based Family therapy (ABFT)
Attachment-Based Family Therapy (ABFT) is a brief manualized therapy designed exclusively for depressed adolescents and aims at reducing adolescent depression by improving family communication and trust.
Other Names:
  • ABFT
  • TAU
Active Comparator: 2

Treatment as usual (TAU)

No attempt is made to standardize TAU. Regular clinical staff will provide mental health services.

Behavioral: Attachment Based Family therapy (ABFT)
Attachment-Based Family Therapy (ABFT) is a brief manualized therapy designed exclusively for depressed adolescents and aims at reducing adolescent depression by improving family communication and trust.
Other Names:
  • ABFT
  • TAU

Detailed Description:

Depression is a major public health concern among adolescents. Research suggests that it not only is prevalent among adolescents (as many as 20% of adolescents have a depressive episode by the age of 18), but its effects last well into adulthood. Although available studies of psychosocial and pharmacological interventions show promise, there are concerns regarding their effectiveness and possible side effects like increase in suicidal ideation. Family conflict is not only an effect of depression, but also a risk factor for depression. High conflict and dysfunction, have consistently been shown to increase risk for depression. As such, family treatments that target risk and protective factors (e.g., quality of parent-child interaction, parental monitoring) for depression seem promising to reduce depression. The current study is a randomized clinical trail aimed at assessing the effectiveness of a 12-week family based intervention for depressed adolescents (Attachment based family therapy- ABFT). Adolescents referred to specialist mental health hospital in south-west Norway (Stavanger University Hospital) will be randomized to either ABFT or treatment as usual (TAU). Therapists administering both the experimental and control group intervention are regular staff clinicians. Outcome assessments would be carried out at baseline, 6, 12 and 26 weeks by raters blind to the condition of the treatment.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 13-17 years
  • Referred to specialist mental health hospital
  • HAM-D score of >14
  • Meets diagnostic criteria for major depressive disorder or depression NOS
  • Have a parent or guardian willing to participate

Exclusion Criteria:

  • Suicidal and require in-patient care
  • Low intellectual abilities
  • Current psychosis
  • primary caregiver unwilling to participate
  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: NCT00700609

Locations
Norway
Department of Child and Adolescent Psychiatry, Stavanger University Hospital
Stavanger, Rogaland, Norway, 4095
Sponsors and Collaborators
Helse Stavanger HF
The Research Council of Norway
Investigators
Principal Investigator: Pravin Israel, Ph.D Stavanger University Hospital, Norway
  More Information

No publications provided

Responsible Party: Dr. Pravin Israel, Stavanger University Hospital
ClinicalTrials.gov Identifier: NCT00700609     History of Changes
Other Study ID Numbers: 18651
Study First Received: June 13, 2008
Last Updated: September 17, 2009
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Helse Stavanger HF:
Depression
Family Therapy
Adolescents

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

ClinicalTrials.gov processed this record on October 23, 2014