Family Based Treatment of Depressed Adolescents | NCT00700609

Studies
Family Based Treatment of Depressed Adolescents

NCT00700609

Sponsor

Helse Stavanger HF

Status

Terminated

Last Update Posted

Jul 31, 2015Estimated

Enrollment

20Actual

Phase

Phase 2

Conditions

Depressive Disorder
Mood Disorder
Major Depression

Interventions

Attachment Based Family therapy (ABFT)

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The PI moved to another city and position

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Jun 13, 2008

First Submission Date that Met QC Criteria

Jun 13, 2008

First Posted Date

Jun 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2015

Last Update Posted Date

Jul 31, 2015Estimated

Name	Class
The Research Council of Norway	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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)
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)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Attachment Based Family therapy (ABFT)	Behavioral	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pravin Israel, Ph.D	Helse Stavanger HF	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Child and Adolescent Psychiatry, Stavanger University Hospital		Stavanger	Rogaland	4095	Norway

Condition Browse Module

MeSH Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D003865	Depressive Disorder, Major
D003863	Depression

Ancestor Terms

ID	Term
D001523	Mental Disorders
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided