Evaluating the Back 2 School Program in a Norwegian Setting: A Multicenter Pilot Study

Depression, Anxiety Clinical Trial

Official title: Evaluating the Back 2 School Program in a Norwegian Setting: A Multicenter Pilot Study

Status Recruiting

Clinical Trial Summary

The goal of this interventional pilot 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? 16 youth (6-16 years) with school attendance problems, their caregivers and the school participate 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.

Clinical Trial Description

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 planned pilot 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 pilot study in Norway, B2S is evaluated in 8 municipalities during the school term of 2022-2023. Participants will be 16 young people (6-16 years), their parents/caregivers and their school.

The pilot 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 pilot study.

By using a mixed method approach the study will combine quantitative and qualitative methods addressing the following research questions:

Quantitative:

1. What are the characteristics of youths with SA and their families?

2. What are the changes in school absence rate, school related self-efficacy, and psychological difficulties following the intervention?

3. What additional needs for interventions and services are identified at termination of the program?

4. What is the degree of drop out, and level of satisfaction with the B2S program among children, parents and teachers?

Qualitative:

5. How do children, youths and their caregivers experience the B2S program? In what ways has the intervention been helpful? Are there ways the program and service system should be changed to better fit the needs of the youth and families struggling with SA? What would be optimized treatment and services for this group?

6. How do the team of professionals experience working with the B2S program to help children and youth with problematic SA? How did the professionals experience the training, the manual and the supervision? Are there ways the program and service system should be changed to better fit the needs of the youngster and families struggling with SA? What do the therapists consider to be optimized treatment and services for this group?

7. How do school staff experience the B2S program and the extended school module?

Based on the findings from the pilot study the aim is to answer the following questions:

• How should a larger-scale implementations study of the Back 2 School program be planned, optimized and conducted?

• What should be the treatment comparison condition?

• What is an optimal level of school involvement in B2S?

Project period Data for the pilot project will be collected during the school year of 2022 -2023. The analysis of the results and writing of reports are planned for the two first trimesters of 2023. During the same time the project group plans to write the application 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:

16 youth (6-16 years of age) will be included in the pilot study. The study will be conducted in eight Norwegian municipalities. Each region (East, West, Middle, North) recruits one to two teams of professionals from their geographical area. The setting for the B2S intervention is within first line services in the municipalities that are imposed to provide services for the target group.

Procedure:

Therapists Each municipality forms a B2S Team consisting of three professionals. The teams will be 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 receive a 5-days training course comprising assessment measures and proceedings, case formulation and the Back 2 School manual. Following training, the teams will be given 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 receive 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 are referred to communal services can be invited to a information meeting regarding the B2S intervention. Children and/or caregivers that for whatever reason is not eligible for the B2S program will be assigned the communal service´s ordinary measures. Children and caregivers that meet inclusion criteria and do not meet exclusion criteria, and that wish to sign up for the intervention, can be included in the pilot study.

Assessment All data collection and assessment within the pilot study are 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 are collected on paper forms. Children, parents/caregivers and teachers fill out separate forms. At inclusion to the pilot study, the youth, parents and teachers immediately start to register school absence (primary outcome) daily on paper form. The Back 2 School team send the T1 collection of questionnaires on paper forms to the families by post or the questionnaires are handed to the families when they sign the informed consent to participate in the pilot study. Youth aged ≤ 11 years can fill out the questionnaire themselves. Children aged 8 to 10 years can fill out the questionnaire with the aid from the B2S counselor/team. Children aged 6 to 7 years will not be asked to respond to the questionnaires.

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.

At termination of the B2S program, an evaluation of outcomes and further needs of intervention or treatment will be discussed with the families. Youths with unchanged or worsened absenteeism following the intervention, and youths with clinical levels of anxiety, depression, or behavioral disturbance will be referred for further treatment. Registration of what additional interventions or other services that are attended is recorded at T2 as well as at follow- up (T3).

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 pilot study, an extended school module developed for this study is 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. ;

Related Conditions & MeSH terms

• Absence
• Depression, Anxiety
• Phobic Disorders
• School Phobia
• Truancy; Socialized

• NCT number: NCT05647499
• Study type: Interventional
• Source: University of Tromso
• Contact: Toril S Nilsen, PHD
• Phone: +4791194758
• Email: toril.nilsen@uit.no
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2022
• Completion date: June 30, 2024