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

June 13, 2008
September 17, 2009
June 2008
March 2009   (final data collection date for primary outcome measure)
Hamilton Depression Rating scale (HAM-D, 17 items) [ Time Frame: Baseline, 6, 12 and 26 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00700609 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Family Based Treatment of Depressed Adolescents
Family-Based Treatment of Depressed Adolescents: An Empirical Study With Norwegian Adolescents in Specialty Mental Health Care

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Depressive Disorder
  • Mood Disorder
  • Major Depression
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
  • Experimental: 1

    Attachment Based Family Therapy (ABFT)

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

    Intervention: Behavioral: Attachment Based Family therapy (ABFT)
  • Active Comparator: 2

    Treatment as usual (TAU)

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

    Intervention: Behavioral: Attachment Based Family therapy (ABFT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
December 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
13 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00700609
18651
Yes
Dr. Pravin Israel, Stavanger University Hospital
Helse Stavanger HF
The Research Council of Norway
Principal Investigator: Pravin Israel, Ph.D Stavanger University Hospital, Norway
Helse Stavanger HF
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP