NCT00700609

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

9 months

First QC Date

June 13, 2008

Last Update Submit

July 30, 2015

Conditions

Keywords

DepressionFamily TherapyAdolescents

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Rating scale (HAM-D, 17 items)

    Baseline, 6, 12 and 26 weeks

Secondary Outcomes (2)

  • Beck depression Inventory (BDI-II)

    Bi-weekly for 12 weeks

  • Kiddie- SADS (diagnostic interview)

    Baseline and 26 weeks

Study Arms (2)

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

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.

Also known as: ABFT, TAU
12

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Suicidal and require in-patient care
  • Low intellectual abilities
  • Current psychosis
  • primary caregiver unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Child and Adolescent Psychiatry, Stavanger University Hospital

Stavanger, Rogaland, 4095, Norway

Location

MeSH Terms

Conditions

Depressive DisorderMood DisordersDepressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Pravin Israel, Ph.D

    Helse Stavanger HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2008

First Posted

June 18, 2008

Study Start

June 1, 2008

Primary Completion

March 1, 2009

Study Completion

December 1, 2009

Last Updated

July 31, 2015

Record last verified: 2015-07

Locations