Back2School - CBT Intervention for School Absenteeism

Depressive Symptoms Clinical Trial

— B2S  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03459677
• Other study ID #: Sponsor
• Status: Completed
• Phase: N/A
• Start date: August 25, 2017
• Est. completion date: December 1, 2020

Study information

• Verified date: April 2019
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety Symptoms
• Behavioral Problem
• Depression
• Depressive Symptoms
• Problem Behavior
• School Absenteeism

Intervention

Behavioral:
• Back2School
Modular Trans-diagnostic Cognitive Behavioral Therapy treating school absenteeism in youths

Other:
• Treatment As Usual
Aarhus municipality's treatment as usual for youths presenting school absenteeism

Locations

Country	Name	City	State
Denmark	Aarhus University, Department of Psychology and Behavioural Sciences	Århus

Sponsors (5)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus County, Denmark, Innovation Fund Denmark, The Danish Mental Health Foundation, TRYG Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Experience of Service Questionnaire (ESQ)	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	Post-treatment (4-months), 3-months follow-up.
Other	Collaboration with the school	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.	Post-treatment (4-months), 3-months follow-up, 12-months follow-up
Primary	Change in School Attendance - Registry data	Aarhus Municipality's registry data of the youths' school attendance	Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
Primary	Change in School Attendance - Self-reported data	Self-reported school attendance in the previous two weeks, reported by parents.	Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
Secondary	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.	Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
Secondary	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.	Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
Secondary	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.	Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
Secondary	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.	Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
Secondary	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.	Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
Secondary	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.	Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up
Secondary	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.	Baseline, post-treatment (4-months), 3-months follow-up, 12-months follow-up