Family Based Treatment of Depressed Adolescents

Depressive Disorder Clinical Trial

— BudFam  

Official title:

Family-Based Treatment of Depressed Adolescents: An Empirical Study With Norwegian Adolescents in Specialty Mental Health Care

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00700609
• Other study ID #: 18651
• Status: Terminated
• Phase: Phase 2
• First received: June 13, 2008
• Last updated: July 30, 2015
• Start date: June 2008
• Est. completion date: December 2009

Study information

• Verified date: July 2015
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depression
• Mood Disorder
• Mood Disorders

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.

Locations

Country	Name	City	State
Norway	Department of Child and Adolescent Psychiatry, Stavanger University Hospital	Stavanger	Rogaland

Sponsors (2)

Lead Sponsor	Collaborator
Helse Stavanger HF	The Research Council of Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating scale (HAM-D, 17 items)		Baseline, 6, 12 and 26 weeks	No
Secondary	Beck depression Inventory (BDI-II)		Bi-weekly for 12 weeks	No
Secondary	Kiddie- SADS (diagnostic interview)		Baseline and 26 weeks	Yes