An interventional study of The Back 2 School program for problematic school absenteeism in Absence, School Phobia and Truancy; Socialized, sponsored by University of Tromso. Completed at 4 sites in Norway. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2024-06-25.
Sponsored by University of Tromso · Not applicable, Interventional, and Treatment
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Among 109 studies in Depression with a site in Norway — 22 open to participants now, 31 under way, none of them phase 3. Depression · Norway.
Among the 109 studies in Depression with a site in Norway, this one is the 77th largest by enrollment of the 81 interventional ones that give a count, is one of 7 that started in 2022, is one of 66 with no phase, and was the 87th registered.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
Browse Depression studies →22 of the 109 studies in Depression with a site in Norway are open now. Recruiting first, the newest first:
Sorlandet Hospital HF · Sites in Norway
Ages 16–25
University of Bergen · Sites in Norway
Ages 18–40 · Healthy volunteers
University Hospital of North Norway · Sites in Norway
Ages 18–65
Solli Distriktspsykiatriske Senter · Sites in Norway
Ages 18–65
Norwegian University of Science and Technology · Sites in Norway
Ages 18–65
A study can be open while its sites in Norway have not opened yet or have stopped. Only those recruiting at a site in Norway →
Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.
This study: 6 Years to 16 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
109 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 7 · Phase 3 4 · Phase 4 2
First in 2001; this study’s year is marked. 7 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 14 is below the median of 81 across 7,066 interventional studies indexed under Depression.
Median enrollment 170 across the 81 interventional studies, 575 across the 28 observational. Of the 68 that completed or were terminated, 3 (4%) have results posted.
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4 of 109 have an industry lead sponsor. The 10 most frequent:
University of Tromso is the lead sponsor of 60 studies on the registry; 6 are open to participants now.
University of Tromso has 6 studies filed under Depression — fewer than ten, so there is no comparison to draw.
8 of the studies in Depression with a site in Norway that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05734547Norwegian Center for Violence and Traumatic Stress StudiesStepping Together for Children After Trauma, Norway | 2026-12-01 |
| NCT07864324University Hospital of North NorwayHigh-Intensity Interval Training and Mental Health in Psychiatric Inpatients | 2026-12-15 |
| NCT06777693NKS Olaviken Gerontopsychiatric HospitalThe Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Older Adults: a Feasibility Study | 2026-12-24 |
| NCT07000799University of OsloA Study of School Absenteeism and Student Well-being in Elementary Schools | 2026-12-31 |
| NCT06568419Solli Distriktspsykiatriske SentereBehandling - Health and Work for Patients in Specialist Mental Health Care | 2027-04 |
Add all 8 to your calendar (.ics) → With an account.
Among the 109 studies in Depression with a site in Norway, from their registry updates:
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The goal of this interventional feasibility study is to gain experiences in using the Back 2 School (B2S) program for youth with school attendance problems in Norwegian community school- and health services. The main questions it aims to answer are: • What is the feasibility of the Back 2 School program when implemented in Norwegian community school- and health services? • What are the changes in school attendance rates, measures of psychological difficulties, and school related self-efficacy following the intervention? • How do participants experience the B2S program? 14 youth (10-15 years) with school attendance problems, their caregivers and the school participated in the B2S program provided by an interdisciplinary team during the school term of 2022-2023. Researchers will compare school attendance rates before entrance to the B2S program, at termination of the program and at 3-month follow-up. Also, researchers will compare reports on psychological difficulties, quality of life, and school related-self efficacy at baseline and after the intervention. Researchers investigate participants experiences with the program through qualitative interviews with youths, caregivers, teachers and service providers. The researchers further aim to prepare and establish resources and infrastructure for a large intervention study, and to establish a well-functioning cooperation between researchers, research organizations, and municipalities in different regions.
In Norway, there is no systematic approach for helping youth with school attendance problems. It is important to evaluate potential effective interventions and procedures for these youths. Back 2 School (B2S) is a modular cognitive behavioral intervention for youth with school attendance problems developed and evaluated through a randomized controlled trial by Professor Mikael Thastum and colleagues at the University of Aarhus, Denmark. The theoretical approach of the B2S program is trans-diagnostic, based on a modular cognitive behavior therapy (CBT) manual. The program aims at addressing both school attendance problems and mental health problems that are associated with school absenteeism.
The feasibility study is a collaboration between researchers at the Regional Centers for Child and Youth Mental Health and Child Welfare in Norway (RKBU North, West, Middle and RBUP South/East), and at the University of Bergen, Stavanger, Norwegian University of Science and Technology (NTNU), UiT The Arctic University of Norway, and the University of Aarhus, Denmark.
In a nationwide feasibility study in Norway, B2S is evaluated in 8 municipalities during the school term of 2022-2023. Participants was 14 young people (10-15 years), their parents/caregivers and their school.
The feasibility study has several aims. One overall aim is to gain experience in using the Back 2 School program in Norwegian community school- and health services and to assess the the feasibility of the program in those settings. Another aim is to prepare and establish resources and infrastructure for a larger intervention study, and to establish a well-functioning cooperation between researchers, research organizations, and municipalities in different regions. Also, questions regarding the process of implementation of the program in community service settings will be an important issue for the study.
By using a mixed method approach the study will combine quantitative and qualitative methods addressing the following research questions:
Quantitative:
What is the degree of drop out, and level of satisfaction with the B2S program among children, parents and teachers?
Qualitative:
Based on the findings from the pilot study the aim is to answer the following questions:
Project period Data for the feasibility study was collected during the school year of 2022 -2023. The analysis of the results and writing of reports are under actual preparation in 2024. The project group are currently applying for funding of the national effectiveness and implementation study, the main study.
The 5- day training of the professionals in the B2S program took place in March 2022. Beforehand, the teams have recruited a case for the first implementation of the program (the rehearsal case). The data collected during the rehearsal case is not included in the database of the pilot. From September/October 2022 through June 2023 each team will conduct the B2S program and collect data from two cases each.
Methods:
Participants and settings:
14 youth (10-15 years of age) was included in the feasibility study. The study was conducted in eight Norwegian municipalities. Each region (East, West, Middle, North) recruited one to two teams of professionals from their geographical area. The setting for the B2S intervention was within first line services in the municipalities that are imposed to provide services for the target group.
Procedure:
Therapists Each municipality formed a B2S Team consisting of three professionals. The teams were interdisciplinary including both member(s) with a relevant health profession (clinical psychologist, medical doctor, health nurse, social educator) and member(s) within a pedagogical profession (teacher, special educator).
Training All professionals received a 5-days training course comprising assessment measures and proceedings, case formulation and the Back 2 School manual. Following training, the teams had weekly supervision by an interdisciplinary team of supervisors, consisting of 1 CBT expert and one with educational professional background, to ensure adherence and quality in delivery. Professionals providing the B2S intervention received a total of 70 hours of training (35 hours) and supervision (estimated 35 hours) during the pilot study.
Recruitment Children and youth with problematic school absenteeism (defined as above 10% absence during the last 3 months of school) that were referred to communal services was invited to a information meeting regarding the B2S intervention. Children and/or caregivers that for whatever reason was not eligible for the B2S program were assigned the communal service´s ordinary measures. Children and caregivers that met inclusion criteria and did not meet exclusion criteria, and that wished to sign up for the intervention, were included in the feasibility study.
Assessment All data collection and assessment within the pilot study were obtained for two main aims: 1) To inform intervention planning and adjustment of the intervention when implementing the B2S program with each individual youth and family, and 2) To answer the research questions of the pilot study.
All assessments within the pilot study were collected on paper forms. Children, parents/caregivers and teachers filled out separate forms. At inclusion to the pilot study, the youth, parents and teachers immediately started to register school absence (primary outcome) daily on paper form. The Back 2 School team sent the T1 collection of questionnaires on paper forms to the families by post or the questionnaires were handed to the families when they signed the informed consent to participate in the pilot study. Youth aged ≤ 11 years could fill out the questionnaire themselves. Children aged 8 to 10 years filled out the questionnaire with the aid from the B2S counselor/team.
Clinical interview and case formulation The intervention starts with the families attending a 3-3.5-hour clinical interview that consists of a range of structured questions. The interview aims to achieve an understanding of the youngster's school absenteeism, development, the family and social situation, and functioning in daily life. The interview also includes a structured joint youth and parent interview developed for the B2S program to assess type and degree of potential mental health problems in the youth.
Following the initial assessment, a case-formulation according is developed in cooperation between the B2S counselor/team and the family. The case formulation is based on the qualitative and quantitative information from the interviews and the baseline measures.
The family and B2S counselor/team identify the motivational function of the child's school absenteeism, which decides which module in the program that will best fit the individual youth and his/her family. When school absenteeism is identified as motivated by positive reinforcement for not attending, CBT procedures targeting parent management and contingency management to minimize the incentives for absenteeism and augment incentives for attendance are indicated. School absenteeism identified as motivated by negative reinforcement for attending school involves CBT procedures such as cognitive restructuring, and exposure-based interventions to reduce anxious or depressive symptoms. The manual includes and targets both specific school attendance problems related tasks, and symptom-specific modules targeting sub-clinical or clinical levels of anxiety, depression, or behavioral problems. During the first two weeks of the intervention, there are two weekly sessions to emphasize the importance of immediately increasing school attendance. The following 6 sessions include weekly or biweekly sessions as appropriate for each family. The conducting of the booster session is flexible regarding the timing and will be held within 3 months after the last session.
The school module: Collaborating with the school is important in the B2S and four meetings with teachers from the youth's school, the therapist, and parents and also a booster session 3 months after the program are included in the manual. In the feasibility study, an extended school module developed for this study was implemented to include the schools from the beginning of the program to facilitate a positive school environment for the child and collaboration between the school and the family. The school module includes a pre-meeting interview with the schools in week 1 and session 1 with the school in week 2 or 3. These are in addition to the sessions described in the Danish manual. The B2S counselor/team and the school will decide whether there is a need for an additional meeting between school meetings 1 and 2 and.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The B2S program is a modular trans-diagnostic cognitive behavioral program aimed at helping children and youth with problematic levels of school absenteeism.
Behavioral: The Back 2 School program for problematic school absenteeism
We will use the Danish version of the revised manual developed within the B2S study in Aarhus, Denmark. The B2S program consists of a 3 to 3,5 -hour initial clinical assessment, a clinical conference, 11 sessions where the youth and/or parent are attending, and a booster session after three months including youth and parent. The B2S manual comprise four school meetings with the child, parents, school staff and therapists present. In the Norwegian pilot study, we will add an extended school module to the B2S-program. The school module includes a pre-meeting interview with the schools in week 1 and session 1 with the school in week 2 or 3. The B2S counselor and the school will decide whether there is a need for an additional meeting between school meetings 1 and 2. There is also a booster session with the child, parents, the school and the B2S team 3 months after the program.
Also known as: Modular cognitive behavior therapy
Change in School absence data
The primary outcome measure is change in school absence data registered on paper-form on a daily basis by teachers, parents' and youths. The informants register presence/absence session by session during their school day, including a remark on presence according to their individual schedule. Official school record absence data is recorded retrospectively during a period of 2 weeks prior to initiation of the program (T1), 2 weeks prior to the finalization of the program (T2) and 2 weeks prior to the 3-month follow-up meetings (T3).
Time frame: 2 weeks prior to initiation of the program (T1), 2 weeks prior to the finalization of the program (T2) and 2 weeks prior to the 3-month follow-up meetings (T3).
The Strengths and Difficulties Questionnaire (SDQ-C/P/T)
The SDQ (Goodman, 1997) is a 25- item screening instrument covering emotional, behavioral and social difficulties, peer relations, prosocial behavior, as well as five questions regarding functional impairment in children and adolescents (2 - 17 years of age). Both the self-report version (from age 11), and the parent- and teacher- report versions will be used. A total problem score,five problem sub-scales and a prosocial behavior scale are computed. Higher scores indicate higher levels of problem on the problem scales, and higher level of prosocial behavior on the prosocial behavior sub-scale
Time frame: At baseline, and up to 12 weeks (at termination)
The Spence Children's Anxiety Scale (SCAS C/P)
The SCAS (Spence, 1998) is a self-report and parent reported rating scale with 38 items (child version includes additional six positive filler items) regarding symptoms of anxiety rated on a 4-point scale. SCAS consists of six sub-scales: social phobia (six items), panic disorder and agoraphobia (nine items), generalized anxiety disorder (six items), obsessive-compulsive disorder (six items), separation anxiety disorder (six items), and fear of physical injury /simple phobia (five items). Both the youth (SCAS-C) and the parent version (SCAS-P) will be used. Raw scores are converted into T-scores with an average of 50 and SD of 10. Higher scores indicate higher levels of anxiety symptoms.
Time frame: At baseline, and at up to 12 weeks (at termination)
The Mood and Feelings Questionnaire (MFQ C/P)
The MFQ (Angold et al., 1995; Costello \& Angold, 1988) is a 33-item screening tool for depression in youths aged 6 to 19 years. In the pilot study we use the short version of the MFQ with 13 items. The MFQ includes a youth (MFQ-C) and a parent version (MFQ-P). Scores are summed and high scores indicated higher levels of depressive symptoms.
Time frame: At baseline, and up to 12 weeks (at termination)
The Self-efficacy Questionnaire for School Situations (SEQ-SS)
SEQ-SS (Heyne, 1998) was developed to assess the expectations of school-refusing youth concerning self-efficacy. The SEQ-SS consists of 12 items, and 2 sub-scales: Academic/Social Stress and Separation/Discipline Stress.A total score is derived by summing the different items, yielding scores from 12-60 points, with higher scores reflecting greater self-efficacy.
Time frame: At baseline, and up to 12 weeks (at termination)
The Self-efficacy Questionnaire Responding to School Attendance Problems (SEQ-RSAP)
SEQ-RSAP (Heyne, Maric, \& Westenberg, 2007) was developed to assess parents' self-efficacy regarding helping their child to attend school regularly and without difficulty. A total score is derived by summing the 25 items, yielding scores between 25 and 100. Higher scores reflect higher self efficacy for responding to SAP.
Time frame: At baseline, and up to 12 weeks (at termination)
About being bullied
Bullying (Olweus, 1993) register the youths' personal experience of being bullied through 2 items. Bullying will be defined as "a student is being bullied when he or she is exposed repeatedly over time to negative and hurtful actions on the part of one or more students. It is difficult for the student being bullied to defend himself or herself. Bullying may take place frequently or infrequently. Bullying can be verbal (e.g., name-calling, threats), physical (e.g., hitting) or psychological (e.g., rumors, shunning/exclusion). It is bullying when someone is teasing repeatedly in a mean or hurtful way" (Olweus, 1993).
Time frame: At baseline, and up to 12 weeks (at termination)
The Family Assessment Device (FAD)
FAD (Epstein, Baldwin, \& Bishop, 1983) was developed to assess dimensions of family function. It consists of three sub-scales, with 60 statements describing various aspects of family functioning. FAD is designed to be completed by family members over the age of 12 years. Scoring is on a 4-point scale (from 1 for strongly agree to 4 for strongly disagree) with the scale for the negatively worded items reversed. Scoring is on a 4-point scale (from 1 for strongly agree to 4 for strongly disagree) with the scale for the negatively worded items reversed. The total score is then divided by the number of items on the sub-scale giving a total score ranging from 1.0 (best functioning) to 4.0 (worse functioning).
Time frame: At baseline, and up to 12 weeks (at termination)
KIDSCREEN-27
KIDSCREEN-27 (Ravens-Sieberer, 2006) is a 27-item scale used to assess generic health-related quality of life. The KIDSCREEN comes in a child version and a parent proxy-version. The scale has five dimensions: Physical Well-Being, Psychological Well-Being, Autonomy \& Parents, Peers \& Social Support and School Environment. Raw Scores are converted in to T-scores with an average of 50 and SD 10. Higher scores reflect higher levels of QoL.
Time frame: At baseline, and up to 12 weeks (at termination)
Plan to share: No
Ran from Sep 2022 to primary completion in Aug 2023, 10 months.
Of 3,471 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 10 months is below that.
Counting every sponsor, half of 3,569 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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University of Tromso