Family Based Treatment of Depressed Adolescents - Full Text View

Sponsors and Collaborators:	Stavanger University Hospital The Research Council of Norway
Information provided by:	Stavanger University Hospital
ClinicalTrials.gov Identifier:	NCT00700609

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 II

MedlinePlus related topics: Child Mental Health Depression Mental Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Family-Based Treatment of Depressed Adolescents: An Empirical Study With Norwegian Adolescents in Specialty Mental Health Care

Further study details as provided by Stavanger University Hospital:

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 ]

Estimated Enrollment:	60
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Active Comparator 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.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700609

Contacts

Contact: Pravin Israel, Ph.D

pravin@sus.no

Locations

Norway, Rogaland
Department of Child and Adolescent Psychiatry, Stavanger University Hospital	Recruiting
Stavanger, Rogaland, Norway, 4095
Principal Investigator: Pravin Israel, Ph.D

Sponsors and Collaborators

Stavanger University Hospital

The Research Council of Norway

Investigators

Principal Investigator:

Pravin Israel, Ph.D

Stavanger University Hospital, Norway

More Information

Responsible Party:	Stavanger University Hospital ( Dr. Pravin Israel )
Study ID Numbers:	18651
Study First Received:	June 13, 2008
Last Updated:	June 13, 2008
ClinicalTrials.gov Identifier:	NCT00700609
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by Stavanger University Hospital:

Depression
Family Therapy
Adolescents

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders

Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009