NCT02150265

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
163

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

May 23, 2019

Status Verified

May 1, 2019

Enrollment Period

4.5 years

First QC Date

May 26, 2014

Last Update Submit

May 21, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

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

    Diagnostic interview

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

Secondary Outcomes (5)

  • 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

  • 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

Study Arms (2)

Waiting list control group

NO INTERVENTION

6 week waiting list

Individual cognitive behavioral therapy with SMART

EXPERIMENTAL

SMART manual cognitive behavioral therapy individual weekly sessions for 6 weeks

Behavioral: SMART manual cognitive behavioral therapy

Interventions

Individual cognitive behavioral therapy with SMART

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, Norway

Location

Related Publications (2)

  • Lorentzen V, Fagermo K, Handegard BH, Neumer SP, Skre I. Long-term effectiveness and trajectories of change after treatment with SMART, a transdiagnostic CBT for adolescents with emotional problems. BMC Psychol. 2022 Jul 5;10(1):167. doi: 10.1186/s40359-022-00872-y.

  • Lorentzen V, Fagermo K, Handegard BH, Skre I, Neumer SP. A randomized controlled trial of a six-session cognitive behavioral treatment of emotional disorders in adolescents 14-17 years old in child and adolescent mental health services (CAMHS). BMC Psychol. 2020 Mar 14;8(1):25. doi: 10.1186/s40359-020-0393-x.

MeSH Terms

Conditions

Generalized Anxiety DisorderPhobia, SocialAgoraphobiaDepressionPanic Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersPhobic DisordersBehavioral SymptomsBehavior

Study Officials

  • Ingunn Skre, PhD

    UiT Arctic University of Norway

    PRINCIPAL INVESTIGATOR
  • Simon-Peter Neumer, Dr philos

    Regionsenter for barn og unges psykiske helse, Sør-Øst

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2014

First Posted

May 29, 2014

Study Start

January 1, 2013

Primary Completion

June 30, 2017

Study Completion

March 1, 2018

Last Updated

May 23, 2019

Record last verified: 2019-05

Locations