NCT03459677

Brief Summary

The main objective of this study is to examine the efficacy of a new psychological intervention, called Back2School, in helping youths with problematic school absenteeism to return to school. Furthermore, the study will examine how well this program fares against the treatment or interventions that are usually given to youths with school absenteeism (treatment as usual or TAU). Based on previous studies we hypothesize that the Back2School intervention will be better at improving levels of school attendance as compared with treatment as usual (TAU).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

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

August 25, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 15, 2023

Status Verified

April 1, 2019

Enrollment Period

3.3 years

First QC Date

February 15, 2018

Last Update Submit

March 14, 2023

Conditions

Keywords

School RefusalTruancySchool AbsenteeismAnxietyDepressionBehavioral problemsCBT

Outcome Measures

Primary Outcomes (2)

  • Change in School Attendance - Registry data

    Aarhus Municipality's registry data of the youths' school attendance

    Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up

  • Change in School Attendance - Self-reported data

    Self-reported school attendance in the previous two weeks, reported by parents.

    Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up

Secondary Outcomes (7)

  • The Strength and Difficulties Questionnaire (SDQ)

    Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up

  • The Spence Children's Anxiety Scale (SCAS)

    Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up

  • The Mood and Feelings Questionnaire (MFQ)

    Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up

  • The Child Health Utility 9D Index (CHU-9D)

    Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up

  • The Self-efficacy Questionnaire for School Situations (SEQ-SS)

    Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up

  • +2 more secondary outcomes

Other Outcomes (2)

  • The Experience of Service Questionnaire (ESQ)

    Post-treatment (4-months), 3-months follow-up.

  • Collaboration with the school

    Post-treatment (4-months), 3-months follow-up, 12-months follow-up

Study Arms (2)

Back2School Condition

EXPERIMENTAL

The Back2School condition is a Modular Trans-Diagnostic Cognitive Behavioral Therapy (MTCBT) treating school absenteeism in youths. The MTCBT intervention consist of 10 sessions and 4 school meetings, conducted over a period of 4 months.

Behavioral: Back2School

Treatment As Usual Condition

ACTIVE COMPARATOR

The Treatment As Usual condition (TAU) consist of an array of interventions that the municipality is required to give youths presenting school absenteeism. The TAU condition will last for 4 months.

Other: Treatment As Usual

Interventions

Back2SchoolBEHAVIORAL

Modular Trans-diagnostic Cognitive Behavioral Therapy treating school absenteeism in youths

Also known as: B2S
Back2School Condition

Aarhus municipality's treatment as usual for youths presenting school absenteeism

Also known as: TAU
Treatment As Usual Condition

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Youths are enrolled in a public school within the municipality of Aarhus.
  • Aged 7-18 years and in 0-9th grade (excluding second semester of the 9th grade).
  • Report more than 10% absenteeism during the last 3 months of school (excluding legal absence, e.g. permitted extra holidays).
  • The youth and at least one of the two parents understand and speak Danish sufficiently to participate in treatment and complete questionnaires.
  • At least one of the parents is motivated for working on increasing the youths' school attendance.
  • The participating families are willing to participate in assessment, intervention procedures, and acceptance of random assignment to intervention.
  • Written informed consent from the holders of the parental rights and responsibilities (usually both parents).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University, Department of Psychology and Behavioural Sciences

Aarhus, 8000, Denmark

Location

Related Publications (3)

  • Johnsen DB, Lomholt JJ, Heyne D, Jensen MB, Jeppesen P, Silverman WK, Thastum M. The Effectiveness of Modular Transdiagnostic Cognitive Behavioral Therapy Versus Treatment as Usual for Youths Displaying School Attendance Problems: A Randomized Controlled Trial. Res Child Adolesc Psychopathol. 2024 Sep;52(9):1397-1412. doi: 10.1007/s10802-024-01196-8. Epub 2024 May 13.

  • Johnsen DB, Lomholt JJ, Heyne D, Jeppesen P, Jensen MB, Silverman WK, Thastum M. Sociodemographic and clinical characteristics of youths and parents seeking psychological treatment for school attendance problems. PLoS One. 2022 Jan 26;17(1):e0261449. doi: 10.1371/journal.pone.0261449. eCollection 2022.

  • Thastum M, Johnsen DB, Silverman WK, Jeppesen P, Heyne DA, Lomholt JJ. The Back2School modular cognitive behavioral intervention for youths with problematic school absenteeism: study protocol for a randomized controlled trial. Trials. 2019 Jan 8;20(1):29. doi: 10.1186/s13063-018-3124-3.

MeSH Terms

Conditions

Anxiety DisordersDepressionProblem BehaviorPhobia, School

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorChild BehaviorPhobic Disorders

Study Officials

  • Mikael Thastum, Professor

    Aarhus University, Department of Psychology and Behavioural Sciences

    PRINCIPAL INVESTIGATOR
  • Johanne L Jeppesen, PhD

    Aarhus University, Department of Psychology and Behavioural Sciences

    STUDY DIRECTOR
  • Daniel B Johnsen, PhD Fellow

    Aarhus University, Department of Psychology and Behavioural Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study is a randomized controlled superiority trial (RCT) that compares a modular trans-diagnostic CBT intervention (Back2School), treating school absenteeism in youths aged 7-17 years with treatment as usual (TAU). The design will follow a two (Back2School and TAU) by four (Time: pre, post, 3-month, and 1-year assessment) mixed between-within design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2018

First Posted

March 9, 2018

Study Start

August 25, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

March 15, 2023

Record last verified: 2019-04

Locations