Family Based Treatment of Depressed Adolescents (BudFam)

July 30, 2015 updated by: Helse Stavanger HF

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Rogaland
      • Stavanger, Rogaland, Norway, 4095
        • Department of Child and Adolescent Psychiatry, Stavanger University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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:
  • TAU
  • ABFT
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:
  • TAU
  • ABFT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hamilton Depression Rating scale (HAM-D, 17 items)
Time Frame: Baseline, 6, 12 and 26 weeks
Baseline, 6, 12 and 26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Beck depression Inventory (BDI-II)
Time Frame: Bi-weekly for 12 weeks
Bi-weekly for 12 weeks
Kiddie- SADS (diagnostic interview)
Time Frame: Baseline and 26 weeks
Baseline and 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Stavanger HF

Collaborators

The Research Council of Norway

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

June 13, 2008

First Submitted That Met QC Criteria

June 13, 2008

First Posted (Estimate)

June 18, 2008

Study Record Updates

Last Update Posted (Estimate)

July 31, 2015

Last Update Submitted That Met QC Criteria

July 30, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18651

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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