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Clinical Trials/NCT02150265
NCT02150265
Completed
Not Applicable

Effectiveness of Cognitive Behavioral Short-term Treatment for Adolescents With Emotional Symptom Problems in Community Clinics in Norway. A Randomized Controlled Study

University of Tromso1 site in 1 country163 target enrollmentStarted: January 1, 2013Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
163
Locations
1
Primary Endpoint
Status of primary emotional disorder based on theDevelopment and Well-Being Assessment (DAWBA) interview schedule with parents and youths

Overview

Brief Summary

Background: There is need for more effectiveness studies concerning treatment of emotional symptom problems indicating anxiety and depression in adolescents. SMART is the only treatment manual for combined emotional disorders developed in Norwegian.

Purpose: To find the best individualized treatment for adolescents with emotional difficulties by: Finding criteria for the selection of appropriate patients for treatment with cognitive-behavior therapy program SMART in an outpatient population (14-18 years). Finding predictors of completion of treatment program SMART. Examining the effects of treatment with the SMART program at 6 months follow-up.

Design: A randomized controlled study in six outpatient clinics in the north of Norway. N= 160 referred adolescents (14-18 years) with score above 6 on the Emotional Problems scale of the Strength and Difficulties Questionnaire (SDQ). Two thirds are treated according to the SMART-manual immediately, while the waiting list control group is treated with SMART after six weeks.

Hypothesis: The SMART treatment is an effective treatment for emotional symptom problems.

Publication: The results sought published internationally and nationally and will be communicated to clinicians.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
14 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age 14 to 18 years Referred to Community Mental Health Clinic for Children and Adolescents
  • Score above 6 on Emotional symptoms scale on the SDQ Fluent Norwegian language

Exclusion Criteria

  • Indicators for Pervasive Developmental Disorder (PDD) Acute suicidal symptoms Psycho-active drug treatment start coinciding with start of intervention Symptoms indicating psychotic disorder

Outcomes

Primary Outcomes

Status of primary emotional disorder based on theDevelopment and Well-Being Assessment (DAWBA) interview schedule with parents and youths

Time Frame: At recruitment, before treatment start and at 6 months follow up

Diagnostic interview

Secondary Outcomes

  • Life functioning as measured by the rating scale C-GAS rated by clinicians(At recruitment, before treatment start and at 6 months follow up)
  • General outcome measured by Clinical Outcomes in Routine Evaluations Outcome Measure (CORE-OM)(At recruitment, before treatment start and at 6 months follow up. The short version (CORE 10) mid-therapy: 3 weeks after starting treatment)
  • SDQ Strengths and Difficulties Questionnaire(At recruitment, before treatment start and at 6 months follow up)
  • Anxiety symptom score on the Multi-Dimensional Anxiety Scale for Children (MASC)(At recruitment, before treatment start and at 6 months follow up)
  • Depression symptom status as measured by the self-rating instrument Beck Depression Inventory (BDI-II)(At recruitment, before treatment start and at 6 months follow up)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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