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Family Based Treatment of Depressed Adolescents (BudFam)

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ClinicalTrials.gov Identifier: NCT00700609
Recruitment Status : Terminated (The PI moved to another city and position)
First Posted : June 18, 2008
Last Update Posted : July 31, 2015
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
Helse Stavanger HF

Brief Summary:
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 or disease Intervention/treatment Phase
Depressive Disorder Mood Disorder Major Depression Behavioral: Attachment Based Family therapy (ABFT) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Family-Based Treatment of Depressed Adolescents: An Empirical Study With Norwegian Adolescents in Specialty Mental Health Care
Study Start Date : June 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Hamilton Depression Rating scale (HAM-D, 17 items) [ Time Frame: Baseline, 6, 12 and 26 weeks ]

Secondary Outcome Measures :
  1. Beck depression Inventory (BDI-II) [ Time Frame: Bi-weekly for 12 weeks ]
  2. Kiddie- SADS (diagnostic interview) [ Time Frame: Baseline and 26 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00700609


Locations
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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
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Principal Investigator: Pravin Israel, Ph.D Stavanger University Hospital, Norway

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Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT00700609     History of Changes
Other Study ID Numbers: 18651
First Posted: June 18, 2008    Key Record Dates
Last Update Posted: July 31, 2015
Last Verified: July 2015

Keywords provided by Helse Stavanger HF:
Depression
Family Therapy
Adolescents

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