NCT05647499

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 30, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 12, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

11 months

First QC Date

October 30, 2022

Last Update Submit

June 21, 2024

Conditions

Keywords

School absence problemsCognitive behavioral intervention

Outcome Measures

Primary Outcomes (1)

  • 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).

    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).

Secondary Outcomes (8)

  • The Strengths and Difficulties Questionnaire (SDQ-C/P/T)

    At baseline, and up to 12 weeks (at termination)

  • The Spence Children's Anxiety Scale (SCAS C/P)

    At baseline, and at up to 12 weeks (at termination)

  • The Mood and Feelings Questionnaire (MFQ C/P)

    At baseline, and up to 12 weeks (at termination)

  • The Self-efficacy Questionnaire for School Situations (SEQ-SS)

    At baseline, and up to 12 weeks (at termination)

  • The Self-efficacy Questionnaire Responding to School Attendance Problems (SEQ-RSAP)

    At baseline, and up to 12 weeks (at termination)

  • +3 more secondary outcomes

Study Arms (1)

The Back 2 School program (B2S) for problematic school absenteeism

EXPERIMENTAL

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

Interventions

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
The Back 2 School program (B2S) for problematic school absenteeism

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Youth enrolled in a public school within the municipality,
  • aged 6-16 years and in 1st to -10th grade (excluding second semester of the 10th grade),
  • having a level of school absenteeism above 10% during the last 3 months of school (excluding legal absence, e.g., permitted extra holidays),
  • The youth and at least one parent/caregiver understand and speak Norwegian sufficiently to participate in the intervention and complete questionnaires,
  • At minimum one of the parents is motivated for working on increasing the youth's school attendance,
  • The participating families are willing to record baseline levels of school absenteeism and to participate in assessment, intervention procedures, and follow-up assessment,
  • Written informed consent from caregiver with judicial parental rights and responsibilities (usually both parents) to take part in the B2S pilot study is obtained.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

NORCE research center

Bergen, 5008, Norway

Location

Regionssenter for barn og unge (RBUP)

Oslo, 0484, Norway

Location

UiT The Arctic University Norway

Tromsø, 9037, Norway

Location

Norges Tekniske Naturvitenskapelige Universitet

Trondheim, 7491, Norway

Location

Related Publications (9)

  • Epstein, N. B., Baldwin, L. M., & Bishop, D. S. (1983). The McMaster Famility Assessment Device. Journal of Marital and Family Therapy, 9(2), 171-180.

    BACKGROUND
  • Heyne, D., Maric, M., & Westenberg, M. (2007). "Self-Efficacy Questionnaire for Responding to School Attendance Problems" Unpublished measure. Leiden the Netherlands.

    BACKGROUND
  • Ravens-Sieberer U. [Special aspects of the quality of life of children]. Dtsch Med Wochenschr. 2006 May 12;131(19 Suppl 1):S27-30. doi: 10.1055/s-2006-941737. German.

    PMID: 16688662BACKGROUND
  • Thastum M, Johnsen DB, Silverman WK, Jeppesen P, Heyne DA, Lomholt JJ. The Back2School modular cognitive behavioral intervention for youths with problematic school absenteeism: study protocol for a randomized controlled trial. Trials. 2019 Jan 8;20(1):29. doi: 10.1186/s13063-018-3124-3.

    PMID: 30621787BACKGROUND
  • Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x.

  • Costello EJ, Angold A. Scales to assess child and adolescent depression: checklists, screens, and nets. J Am Acad Child Adolesc Psychiatry. 1988 Nov;27(6):726-37. doi: 10.1097/00004583-198811000-00011. No abstract available.

  • Spence SH. A measure of anxiety symptoms among children. Behav Res Ther. 1998 May;36(5):545-66. doi: 10.1016/s0005-7967(98)00034-5.

  • Heyne, D., King, N., Tonge, B., Rollings, S., Pritchard, M., Young, D., & Myerson, N. (1998). The self-efficacy questionnaire for school situations: Development and psychometric evaluation. Behaviour Change, 15(1), 31-40. https://doi.org/10.1017/S081348390000588X

    RESULT
  • Jeppesen P, Wolf RT, Nielsen SM, Christensen R, Plessen KJ, Bilenberg N, Thomsen PH, Thastum M, Neumer SP, Puggaard LB, Agner Pedersen MM, Pagsberg AK, Silverman WK, Correll CU. Effectiveness of Transdiagnostic Cognitive-Behavioral Psychotherapy Compared With Management as Usual for Youth With Common Mental Health Problems: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Mar 1;78(3):250-260. doi: 10.1001/jamapsychiatry.2020.4045.

MeSH Terms

Conditions

Phobia, SchoolDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Phobic DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Frode Adolfsen, PHD

    UiT

    STUDY CHAIR
  • Kristin G Askeland, PHD

    NORCE Norwegian Research Centre AS

    STUDY CHAIR
  • Simon P Neumer, PHD

    Regionssenter for barn og unge

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The evaluation of changes in school attendance (primary outcome) following the B2S program will be conducted using a multiple - baseline across subjects' design comparing the individuals' baseline levels of school absenteeism with the level of absenteeism following participation in the B2S program. The structure of the multiple baseline design with 14 subjects is comprised of two treatment conditions, a baseline (control) and an intervention condition with N equally spaced measurement occasions (Hedges, Pustejovsky, \& Shadish, 2013). Thus, each subject function as their own control. Changes in secondary outcome measures (psychological wellbeing, school related self-efficacy) are assessed through repeated measurement at pre- (T1), and post intervention (T2).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 30, 2022

First Posted

December 12, 2022

Study Start

September 20, 2022

Primary Completion

August 15, 2023

Study Completion

August 30, 2023

Last Updated

June 25, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations