Back2School - CBT Intervention for School Absenteeism (B2S)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03459677|
Recruitment Status : Completed
First Posted : March 9, 2018
Last Update Posted : March 15, 2023
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
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).
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Symptoms Depressive Symptoms Behavioral Problem School Absenteeism||Behavioral: Back2School Other: Treatment As Usual||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||155 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||None (Open Label)|
|Official Title:||Cognitive Behavioral Therapy Intervention for School Absenteeism: a Randomized Controlled Trial|
|Actual Study Start Date :||August 25, 2017|
|Actual Primary Completion Date :||December 1, 2020|
|Actual Study Completion Date :||December 1, 2020|
Experimental: Back2School Condition
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.
Modular Trans-diagnostic Cognitive Behavioral Therapy treating school absenteeism in youths
Other Name: B2S
Active Comparator: Treatment As Usual Condition
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
Aarhus municipality's treatment as usual for youths presenting school absenteeism
Other Name: TAU
- 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.
- The Strength and Difficulties Questionnaire (SDQ) [ Time Frame: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up ]
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) [ Time Frame: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up ]
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) [ Time Frame: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up ]
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) [ Time Frame: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up ]
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) [ Time Frame: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up ]
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) [ Time Frame: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up ]
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) [ Time Frame: Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up ]
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.
- The Experience of Service Questionnaire (ESQ) [ Time Frame: Post-treatment (4-months), 3-months follow-up. ]
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
- Collaboration with the school [ Time Frame: Post-treatment (4-months), 3-months follow-up, 12-months follow-up ]
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||7 Years to 18 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459677
|Aarhus University, Department of Psychology and Behavioural Sciences|
|Århus, Denmark, 8000|
|Principal Investigator:||Mikael Thastum, Professor||Aarhus University, Department of Psychology and Behavioural Sciences|
|Study Director:||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|
|Responsible Party:||University of Aarhus|
|Other Study ID Numbers:||
|First Posted:||March 9, 2018 Key Record Dates|
|Last Update Posted:||March 15, 2023|
|Last Verified:||April 2019|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|