Effectiveness of Six Sessions CBT for Adolescents With Emotional Problems in Community Clinics (SMART)

May 21, 2019 updated by: University of Tromso

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

163

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Tromsø, Norway
        • University Hospital of North Norway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Waiting list control group
6 week waiting list
Experimental: Individual cognitive behavioral therapy with SMART
SMART manual cognitive behavioral therapy individual weekly sessions for 6 weeks
Behavioral: SMART manual cognitive behavioral therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At recruitment, before treatment start and at 6 months follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SDQ Strengths and Difficulties Questionnaire
Time Frame: At recruitment, before treatment start and at 6 months follow up
Measure of general emotional and behavioral symptoms and strengths
At recruitment, before treatment start and at 6 months follow up
Anxiety symptom score on the Multi-Dimensional Anxiety Scale for Children (MASC)
Time Frame: At recruitment, before treatment start and at 6 months follow up
Measure of anxiety symptoms
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)
Time Frame: At recruitment, before treatment start and at 6 months follow up
Measure of depressive symptoms
At recruitment, before treatment start and at 6 months follow up
Life functioning as measured by the rating scale C-GAS rated by clinicians
Time Frame: At recruitment, before treatment start and at 6 months follow up
Measure of functioning
At recruitment, before treatment start and at 6 months follow up
General outcome measured by Clinical Outcomes in Routine Evaluations Outcome Measure (CORE-OM)
Time Frame: At recruitment, before treatment start and at 6 months follow up. The short version (CORE 10) mid-therapy: 3 weeks after starting treatment
Measure of symptoms, risk, functioning and total burden of disorder
At recruitment, before treatment start and at 6 months follow up. The short version (CORE 10) mid-therapy: 3 weeks after starting treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tromso

Collaborators

The Royal Norwegian Ministry of Health
Regionsenter for barn og unges psykiske helse

Investigators

  • Principal Investigator: Ingunn Skre, PhD, UiT Arctic University of Norway
  • Study Chair: Simon-Peter Neumer, Dr philos, Regionsenter for barn og unges psykiske helse, Sør-Øst

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

May 26, 2014

First Submitted That Met QC Criteria

May 28, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Actual)

May 23, 2019

Last Update Submitted That Met QC Criteria

May 21, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/1937
  • 8563/PFP1112-13 (Other Grant/Funding Number: Northern Norway Regional Health Authority (Helse Nord RHF))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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