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Completed

NCT Number: NCT03459677

Back2School - CBT Intervention for School Absenteeism

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).

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Key information

Conditions

Anxiety Symptoms Anxiety Disorders Behavior Behavioral Problem Behavioral Symptoms Child Behavior Depression Depressive Symptoms Mental Disorders Phobia, School Phobic Disorders Problem Behavior School Absenteeism

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University, Department of Psychology and Behavioural Sciences

Aarhus, 8000, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Back2School

Behavioral

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

Other names: B2S

Treatment as Usual

Other

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

Other names: TAU

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  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.

  6. 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.

  7. 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.

Other outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus County, Denmark
  • Innovation Fund Denmark
  • TRYG Foundation
  • The Danish Mental Health Foundation

Registry information

Official study title

Cognitive Behavioral Therapy Intervention for School Absenteeism: a Randomized Controlled Trial

Acronym: B2S

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 9, 2018
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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