NCT00946413

Brief Summary

Cognitive behavioral therapy (CBT) is effective and CBT with parental involvement has potential in preventing and treating adolescent depression. The purpose of this study was to compare the short- and long-term effectiveness of CBT alone and CBT plus parental education for community-based adolescents at risk for depression and suicide in Taiwan. It is hypothesized that the CBT alone and CBT with parental education group are more effective than the control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed
Last Updated

July 27, 2009

Status Verified

July 1, 2009

Enrollment Period

1.9 years

First QC Date

July 24, 2009

Last Update Submit

July 24, 2009

Conditions

Keywords

CBT, Depressed and suicidal adolescents

Outcome Measures

Primary Outcomes (1)

  • depressive symptoms, suicidal ideation, cognitive triad, learned resourcefulness (LR), and salivary cortisol

    6

Study Arms (2)

CBT plus parent education

EXPERIMENTAL
Behavioral: CBT plus parent education

CBT alone

EXPERIMENTAL
Behavioral: CBT alone

Interventions

The 10-session group CBT with two-session parental education in our study was derived from the CWDA, with some modifications made based on cultural considerations. Skills taught and discussed included mood monitoring, improving social skills, increasing pleasant activities, decreasing anxiety, reducing depressogenic cognitions, improving communication, and conflict resolution. The issues taught and discussed included an introduction to adolescent depression and suicide, their etiology, symptoms, treatment, and prognosis, as well as stress management. A 1-year individual follow-up program was used to maintain the effect of the experimental intervention and to provide necessary individual interventions for students such as CBT, support, and counseling.

CBT plus parent education
CBT aloneBEHAVIORAL

The 10-session group CBT with two-session parental education in our study was derived from the CWDA, with some modifications made based on cultural considerations. Skills taught and discussed included mood monitoring, improving social skills, increasing pleasant activities, decreasing anxiety, reducing depressogenic cognitions, improving communication, and conflict resolution.A 1-year individual follow-up program was used to maintain the effect of the experimental intervention and to provide necessary individual interventions for students such as CBT, support, and counseling.

CBT alone

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • willing to participate group assignment and grant consents

You may not qualify if:

  • unwilling to participate potential group activity and grant consents
  • severe physical or psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, Taipei Medical University

Taipei, 110, Taiwan

Location

Related Links

MeSH Terms

Conditions

SuicideColor Vision DefectsConsciousness Disorders

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorVision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesCone DystrophyEye Diseases, HereditaryEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsNeurocognitive DisordersMental Disorders

Study Officials

  • Hsiu-Ju Chang, phD

    School of Nursing, Taipei Meidcal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 24, 2009

First Posted

July 27, 2009

Study Start

January 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

July 27, 2009

Record last verified: 2009-07

Locations