Anxiety SymptomsB2SNCT03459677
Back2School - CBT Intervention for School Absenteeism
A study testing Back2School and Treatment As Usual in people with Anxiety Symptoms and Depressive Symptoms, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Symptoms, Depressive Symptoms, Behavioral Problem
- What is being tested?
- Back2School and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Aug 2017to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University, Department of Psychology and Behavioural Sciences
Aarhus, 8000
About this study
Official title: Cognitive Behavioral Therapy Intervention for School Absenteeism: a Randomized Controlled Trial
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).
Read the 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
- Being tested
- Back2School, Treatment As Usual
- Keywords
- School Refusal, Truancy, School Absenteeism, Anxiety, Depression, Behavioral problems, CBT
- Medical subject headings
- Anxiety Disorders, Depression, Problem Behavior, Phobia, School
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Back2SchoolBehavioural
Also called B2S
Modular Trans-diagnostic Cognitive Behavioral Therapy treating school absenteeism in youths
Treatment As UsualOther
Also called TAU
Aarhus municipality's treatment as usual for youths presenting school absenteeism
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in School Attendance - Registry data
Aarhus Municipality's registry data of the youths' school attendance
Measured: 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.
Measured: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
Secondary outcomes (7)
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.
Measured: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
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.
Measured: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
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.
Measured: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
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.
Measured: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
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.
Measured: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
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.
Measured: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
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.
Measured: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start25 Aug 2017
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anxiety SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus County, Denmark, Innovation Fund Denmark, The Danish Mental Health Foundation, TRYG Foundation
- Responsible party
- Sponsor
- Investigators
- Mikael Thastum, Professor, Principal investigator, Aarhus University, Department of Psychology and Behavioural SciencesJohanne L Jeppesen, PhD, Study director, Aarhus University, Department of Psychology and Behavioural SciencesDaniel B Johnsen, PhD Fellow, Study director, Aarhus University, Department of Psychology and Behavioural Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459677
- Sponsor's protocol ID
- Sponsor
- Acronym
- B2S
- Status last verified
- Apr 2019
- First submitted
- 15 Feb 2018
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38739306Johnsen 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.
PubMed 35081106Thastum 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.
PubMed 30621787
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy Intervention for School Absenteeism: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03459677
- Acronym / sponsor ID
- B2S / Sponsor
- Keywords
- School Refusal, Truancy, School Absenteeism, Anxiety, Depression, Behavioral problems, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus County, Denmark, Innovation Fund Denmark, The Danish Mental Health Foundation, TRYG Foundation
- Study start
- 25 Aug 2017 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Back2School Condition | Experimental | Behavioral: Back2SchoolThe 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. |
| Treatment As Usual Condition | Active comparator | Other: Treatment As UsualThe 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. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Back2SchoolAlso: B2SModular Trans-diagnostic Cognitive Behavioral Therapy treating school absenteeism in youths | Behavioural | Back2School Condition |
| Treatment As UsualAlso: TAUAarhus municipality's treatment as usual for youths presenting school absenteeism | Other | Treatment As Usual Condition |
Primary outcome
Change in School Attendance - Registry data
Time frame: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
Aarhus Municipality's registry data of the youths' school attendance
Change in School Attendance - Self-reported data
Time frame: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
Self-reported school attendance in the previous two weeks, reported by parents.
7 secondary outcomes
The Strength and Difficulties Questionnaire (SDQ)
Time frame: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
The Spence Children's Anxiety Scale (SCAS)
Time frame: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
The Mood and Feelings Questionnaire (MFQ)
Time frame: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
The Child Health Utility 9D Index (CHU-9D)
Time frame: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
The Self-efficacy Questionnaire for School Situations (SEQ-SS)
Time frame: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
Self-Efficacy Questionnaire for Responding to School Attendance Problems (SEQ-RSAP)
Time frame: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
The Family Assessment Device (FAD)
Time frame: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Derived from this study: PubMed 38739306Johnsen 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.
- Derived from this study: PubMed 35081106Johnsen 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.
- Derived from this study: PubMed 30621787Thastum 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikael Thastum, Professor principal investigator
Aarhus University, Department of Psychology and Behavioural Sciences
Johanne L Jeppesen, PhD study director
Aarhus University, Department of Psychology and Behavioural Sciences
Daniel B Johnsen, PhD Fellow study director
Aarhus University, Department of Psychology and Behavioural Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Back2School and Treatment As Usual in people with Anxiety Symptoms and Depressive Symptoms, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in School Attendance - Registry data (time frame: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03459677, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.