Clinical trial NCT03459677: Back2School - CBT Intervention for School Absenteeism
Official title: Cognitive Behavioral Therapy Intervention for School Absenteeism: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Symptoms
Depressive Symptoms
Behavioral Problem
School Absenteeism
Keywords: School Refusal
Truancy
School Absenteeism
Anxiety
Depression
Behavioral problems
CBT
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus County, Denmark
name: Innovation Fund Denmark
name: The Danish Mental Health Foundation
name: TRYG Foundation
First posted: 2018-03-09
Enrollment: 155
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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).

Detailed description: Primary objective The main objective of this study is to examine the efficacy on school attendance and wellbeing of a modular trans-diagnostic CBT intervention for youths with problematic school absenteeism in a randomized controlled trial. Based on previous studies we hypothesize that the B2S intervention will show a significant difference in impact for school attendance, in favor of Back2School intervention as compared with TAU

Trial design 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.

The study is a collaboration project between Aarhus University and Aarhus Municipality, Denmark. The setting for both the B2S and TAU interventions are within Aarhus municipality. The Back2School intervention is organized and conducted by the University Clinic, at Aarhus University. Treatment as usual interventions are organized and conducted by Aarhus Municipality.

There are considerable negative long-term consequences related to youths with school absenteeism. If the B2S intervention proves to be effective in reducing school absenteeism, it could be implemented in other municipalities in Denmark, and help to systematically treat and help youths with school absenteeism. This could possibly reduce both personal and societal costs significantly

Eligibility criteria: Inclusion Criteria:

* 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).

Primary outcomes:
measure: Change in School Attendance - Registry data
timeFrame: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
measure: Change in School Attendance - Self-reported data
timeFrame: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
Secondary outcomes:
measure: The Strength and Difficulties Questionnaire (SDQ)
timeFrame: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
measure: The Spence Children's Anxiety Scale (SCAS)
timeFrame: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
measure: The Mood and Feelings Questionnaire (MFQ)
timeFrame: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
measure: The Child Health Utility 9D Index (CHU-9D)
timeFrame: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
measure: The Self-efficacy Questionnaire for School Situations (SEQ-SS)
timeFrame: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
measure: Self-Efficacy Questionnaire for Responding to School Attendance Problems (SEQ-RSAP)
timeFrame: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
measure: The Family Assessment Device (FAD)
timeFrame: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
Other outcomes:
measure: The Experience of Service Questionnaire (ESQ)
timeFrame: Post-treatment (4-months), 3-months follow-up.
measure: Collaboration with the school
timeFrame: Post-treatment (4-months), 3-months follow-up, 12-months follow-up
Locations:
city: Århus
country: Denmark
facility: Aarhus University, Department of Psychology and Behavioural Sciences
Study officials:
affiliation: Aarhus University, Department of Psychology and Behavioural Sciences
name: Mikael Thastum, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University, Department of Psychology and Behavioural Sciences
name: Johanne L Jeppesen, PhD
role: STUDY_DIRECTOR
affiliation: Aarhus University, Department of Psychology and Behavioural Sciences
name: Daniel B Johnsen, PhD Fellow
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.