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Back2School - CBT Intervention for School Absenteeism (B2S)

Primary Purpose

Anxiety Symptoms, Depressive Symptoms, Behavioral Problem

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Back2School
Treatment As Usual
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Symptoms focused on measuring School Refusal, Truancy, School Absenteeism, Anxiety, Depression, Behavioral problems, CBT

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Aarhus University, Department of Psychology and Behavioural Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Back2School Condition

Treatment As Usual Condition

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in School Attendance - Registry data
Aarhus Municipality's registry data of the youths' school attendance
Change in School Attendance - Self-reported data
Self-reported school attendance in the previous two weeks, reported by parents.

Secondary Outcome Measures

The Strength and Difficulties Questionnaire (SDQ)
The SDQ measures psychopathology in youths (3-16 years). There is a SDQ version for youths (SDQ), parents (SDQ-P), and teachers (SDQ-T). The different versions consist of the same items, and are scored identically. Total of 25 items, rated on a 3-point scale (0-2), divided into 5 sub-scales consisting of 5 items. Sub-scales: Emotional symptoms, Conduct problems, Hyperactivity/inattention, Peer relationships problems, Pro-social behavior For each sub-scale, minimum score is 0 and maximum total score is 10 The total score is computed by summing up the sub-scales, with the exception of the "pro-social behavior" sub-scale. Minimum total score is 0, and maximum total score is 40. The extended version of the SDQ includes an impact scale with additional 8 items, regarding child distress and interference. The Impact scale is scored on a 4-point scale (0-3). The impact scale is summed up by counting only scores of 2 or 3. Minimum score 0, and maximum score 24.
The Spence Children's Anxiety Scale (SCAS)
Self-report rating scale assessing youths symptoms of anxiety, rated by youths (SCAS) and parents (SCAS-P). Total of 38 items, rated on a 4-point scale (0-3), divided into 6 sub-scales. The SCAS includes 6 positive filler items not included in the computation of sub-scores or total score. Sub-scales: Social Phobia (6 items), Panic disorder and agoraphobia (9 items), Generalized anxiety disorder (6 items, range 0-18), Obsessive-compulsive disorder (6 items, range 0-18), separation anxiety disorder (6 items, range 0-18), Fear of physical injury (5 items, , range 0-15). Minimum total score is 0, and maximum total score is 114. The SCAS-P is identical to the SCAS in form an scoring, but does not include the 6 positive filler items.
The Mood and Feelings Questionnaire (MFQ)
Covers a broad range of cognitive and vegetative symptoms of depression in youths. There is both a youth (MFQ) and parent (MFQ-P) version of the MFQ. The MFQ consistTotal of 33 items, rated on a 3-point scale (0-2). The MFQ-P consist of 34 items. Both the scores for MFQ and MFQ-P are computed by summing up all items. Higher scores indicating more sever depressive symptoms. Minimum MFQ score is 0, maximum score is 66. Minimum MFQ-P score is 0, maximum score is 68.
The Child Health Utility 9D Index (CHU-9D)
Designed to determine how health affect youths's lives, rated by youths. Consist of 9 items, rated on a 5-point scale. Each item is related to a dimension to how the youths are feeling worried, sad, pain, tired, annoyed, schoolwork/ homework, sleep, daily routine, and participating in activities. Higher scores for each item is related to a higher perceived difficulty related to a dimension. Each dimension/item has a minimum score of 1, and a maximum score of 5.
The Self-efficacy Questionnaire for School Situations (SEQ-SS)
Measures self-efficacy expectations to different school situations, rated by youths. Consist of 12 items, rated on a 5-point scale (1-5), and divided into 2 sub-scales both consisting of 6 items. Minimum SEQ-SS score is 12, maximum score is 60. Higher scores reflect greater self-efficacy expectations.
Self-Efficacy Questionnaire for Responding to School Attendance Problems (SEQ-RSAP)
Measures parents self-efficacy expectations to different school situations, rated by parents. Consist of 13 items, rated on a 4-point scale (1-4). Minimum score is 13, and maximum score is 52. Higher scores reflect greater self-efficacy expectations in parents ability to help their child in different school situations.
The Family Assessment Device (FAD)
Assess different dimensions of family function, rated by youths (12 years and older) and parents. Only the sub-scale regarding General Function is used in this study. The sub-scale consist of 12 items, rated on a 4 point-scale (1-4). The FAD is scored by calculating the mean scores of all items. Higher means are related to a more unhealthy or non-functional family function.

Full Information

First Posted
February 15, 2018
Last Updated
March 14, 2023
Sponsor
University of Aarhus
Collaborators
Aarhus County, Denmark, Innovation Fund Denmark, The Danish Mental Health Foundation, TRYG Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03459677
Brief Title
Back2School - CBT Intervention for School Absenteeism
Acronym
B2S
Official Title
Cognitive Behavioral Therapy Intervention for School Absenteeism: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 25, 2017 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus County, Denmark, Innovation Fund Denmark, The Danish Mental Health Foundation, TRYG Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Symptoms, Depressive Symptoms, Behavioral Problem, School Absenteeism
Keywords
School Refusal, Truancy, School Absenteeism, Anxiety, Depression, Behavioral problems, CBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Back2School Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment As Usual Condition
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Back2School
Other Intervention Name(s)
B2S
Intervention Description
Modular Trans-diagnostic Cognitive Behavioral Therapy treating school absenteeism in youths
Intervention Type
Other
Intervention Name(s)
Treatment As Usual
Other Intervention Name(s)
TAU
Intervention Description
Aarhus municipality's treatment as usual for youths presenting school absenteeism
Primary Outcome Measure Information:
Title
Change in School Attendance - Registry data
Description
Aarhus Municipality's registry data of the youths' school attendance
Time Frame
Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
Title
Change in School Attendance - Self-reported data
Description
Self-reported school attendance in the previous two weeks, reported by parents.
Time Frame
Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
Secondary Outcome Measure Information:
Title
The Strength and Difficulties Questionnaire (SDQ)
Description
The SDQ measures psychopathology in youths (3-16 years). There is a SDQ version for youths (SDQ), parents (SDQ-P), and teachers (SDQ-T). The different versions consist of the same items, and are scored identically. Total of 25 items, rated on a 3-point scale (0-2), divided into 5 sub-scales consisting of 5 items. Sub-scales: Emotional symptoms, Conduct problems, Hyperactivity/inattention, Peer relationships problems, Pro-social behavior For each sub-scale, minimum score is 0 and maximum total score is 10 The total score is computed by summing up the sub-scales, with the exception of the "pro-social behavior" sub-scale. Minimum total score is 0, and maximum total score is 40. The extended version of the SDQ includes an impact scale with additional 8 items, regarding child distress and interference. The Impact scale is scored on a 4-point scale (0-3). The impact scale is summed up by counting only scores of 2 or 3. Minimum score 0, and maximum score 24.
Time Frame
Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
Title
The Spence Children's Anxiety Scale (SCAS)
Description
Self-report rating scale assessing youths symptoms of anxiety, rated by youths (SCAS) and parents (SCAS-P). Total of 38 items, rated on a 4-point scale (0-3), divided into 6 sub-scales. The SCAS includes 6 positive filler items not included in the computation of sub-scores or total score. Sub-scales: Social Phobia (6 items), Panic disorder and agoraphobia (9 items), Generalized anxiety disorder (6 items, range 0-18), Obsessive-compulsive disorder (6 items, range 0-18), separation anxiety disorder (6 items, range 0-18), Fear of physical injury (5 items, , range 0-15). Minimum total score is 0, and maximum total score is 114. The SCAS-P is identical to the SCAS in form an scoring, but does not include the 6 positive filler items.
Time Frame
Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
Title
The Mood and Feelings Questionnaire (MFQ)
Description
Covers a broad range of cognitive and vegetative symptoms of depression in youths. There is both a youth (MFQ) and parent (MFQ-P) version of the MFQ. The MFQ consistTotal of 33 items, rated on a 3-point scale (0-2). The MFQ-P consist of 34 items. Both the scores for MFQ and MFQ-P are computed by summing up all items. Higher scores indicating more sever depressive symptoms. Minimum MFQ score is 0, maximum score is 66. Minimum MFQ-P score is 0, maximum score is 68.
Time Frame
Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
Title
The Child Health Utility 9D Index (CHU-9D)
Description
Designed to determine how health affect youths's lives, rated by youths. Consist of 9 items, rated on a 5-point scale. Each item is related to a dimension to how the youths are feeling worried, sad, pain, tired, annoyed, schoolwork/ homework, sleep, daily routine, and participating in activities. Higher scores for each item is related to a higher perceived difficulty related to a dimension. Each dimension/item has a minimum score of 1, and a maximum score of 5.
Time Frame
Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
Title
The Self-efficacy Questionnaire for School Situations (SEQ-SS)
Description
Measures self-efficacy expectations to different school situations, rated by youths. Consist of 12 items, rated on a 5-point scale (1-5), and divided into 2 sub-scales both consisting of 6 items. Minimum SEQ-SS score is 12, maximum score is 60. Higher scores reflect greater self-efficacy expectations.
Time Frame
Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
Title
Self-Efficacy Questionnaire for Responding to School Attendance Problems (SEQ-RSAP)
Description
Measures parents self-efficacy expectations to different school situations, rated by parents. Consist of 13 items, rated on a 4-point scale (1-4). Minimum score is 13, and maximum score is 52. Higher scores reflect greater self-efficacy expectations in parents ability to help their child in different school situations.
Time Frame
Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
Title
The Family Assessment Device (FAD)
Description
Assess different dimensions of family function, rated by youths (12 years and older) and parents. Only the sub-scale regarding General Function is used in this study. The sub-scale consist of 12 items, rated on a 4 point-scale (1-4). The FAD is scored by calculating the mean scores of all items. Higher means are related to a more unhealthy or non-functional family function.
Time Frame
Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
Other Pre-specified Outcome Measures:
Title
The Experience of Service Questionnaire (ESQ)
Description
Assess the satisfaction with the treatment, rated by youths and parents. The treatment satisfaction for the youths consist of 7 items rated on a 3 point-scale (0-2), with 1 open question. Treatment satisfaction for parents is assessed using 10 items, rated on a 3-point-scale (0-2), with 3 open questions. Higher scores is associated with
Time Frame
Post-treatment (4-months), 3-months follow-up.
Title
Collaboration with the school
Description
Assess the collaboration between the family and the school/teacher. Consist of 3 items rated on a 4-point scale (1-4). Higher scores are related to a good relationship and collaboration with the school. Both parents and teachers respond to this questionnaire.
Time Frame
Post-treatment (4-months), 3-months follow-up, 12-months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikael Thastum, Professor
Organizational Affiliation
Aarhus University, Department of Psychology and Behavioural Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Johanne L Jeppesen, PhD
Organizational Affiliation
Aarhus University, Department of Psychology and Behavioural Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Daniel B Johnsen, PhD Fellow
Organizational Affiliation
Aarhus University, Department of Psychology and Behavioural Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Aarhus University, Department of Psychology and Behavioural Sciences
City
Århus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
35081106
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.
Results Reference
derived
PubMed Identifier
30621787
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.
Results Reference
derived

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Back2School - CBT Intervention for School Absenteeism

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