Clinical trial NCT00700609: Family Based Treatment of Depressed Adolescents
Official title: Family-Based Treatment of Depressed Adolescents: An Empirical Study With Norwegian Adolescents in Specialty Mental Health Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Depressive Disorder
Mood Disorder
Major Depression
Keywords: Depression
Family Therapy
Adolescents
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: The Research Council of Norway
First posted: 2008-06-18
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Hamilton Depression Rating scale (HAM-D, 17 items)
timeFrame: Baseline, 6, 12 and 26 weeks
Secondary outcomes:
measure: Beck depression Inventory (BDI-II)
timeFrame: Bi-weekly for 12 weeks
measure: Kiddie- SADS (diagnostic interview)
timeFrame: Baseline and 26 weeks
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Department of Child and Adolescent Psychiatry, Stavanger University Hospital
state: Rogaland
Study officials:
affiliation: Helse Stavanger HF
name: Pravin Israel, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: