NCT05435937

Brief Summary

This project implements an innovative and intersectional collaborative intervention model that addresses challenges that exist for children with special educational needs, who risk school failure, exclusion and poor health. The aim is to evaluate how the intervention model Partnering for Change (P4C) can be used to provide school-based services for creating an inclusive learning environment, and its effects on students 'conditions for learning, such as students' engagement and participation in school activities. The study has a non-randomized controlled intervention study design with pre-, post- and follow-up measurements.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

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

February 10, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 28, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2024

Completed
Last Updated

June 28, 2022

Status Verified

June 1, 2022

Enrollment Period

1.9 years

First QC Date

June 22, 2022

Last Update Submit

June 22, 2022

Conditions

Keywords

Disabled ChildrenSpecial educational needsPartnering for changeUniversal design for learningParticipationTiered intervention modelInclusive learning environment

Outcome Measures

Primary Outcomes (1)

  • Change in the Engagement Versus Disaffection With Learning: Teacher Report (EEL)

    Engagement Versus Disaffection with Learning: Teacher Report (EEL) is a measure of school engagement from the perspective of a child's teacher. The EEL consists of four subscales across 25 items, and the teacher is instructed to rate on a four-point Likert-type scale, from 1 (Happens almost never) to 4 (Happens very often) how close each item describes the pupil.

    Baseline, four months, eleven months

Secondary Outcomes (7)

  • Change in the Swedish Child Health Utility 9D (CHU9D)

    Baseline, four months, eleven months

  • Change in How I Feel About My School (HIFAMS)

    Baseline, four months, eleven months

  • Change in occupational performance in school-based occupations

    During the four months intervention period

  • Change in attainment of school-based occupational performance goals

    During the four months intervention period

  • Change in School attendance

    Baseline to eleven months

  • +2 more secondary outcomes

Study Arms (2)

P4C-Swe intervention

EXPERIMENTAL

Pupils in participating classes will receive the Partnering for change (P4C) intervention

Behavioral: Partnering for change (P4C-Swe)

Treatment as usual

ACTIVE COMPARATOR

Treatment as usual is provided by the Student health services that consists of a school doctor, school nurse, psychologist and counselor, and staff with special educational competence

Behavioral: Treatment as usual

Interventions

P4C focuses on the collaboration and a intersectional partnership between teachers and occupational therapists/special educators to create physical, social and learning environments that facilitate successful participation for all pupils. The intervention tiered model provides interventions in a school context in levels; class, group, and individual level to students with participation restrictions. Dynamic Performance Analysis (DPA), which focuses on pupils' occupational performance, is used in P4C model to identify and analyze were and why pupils' occupational performance is breaking down in school-based occupations in the natural context, followed by collaboration and coaching between the occupational therapist and teacher in setting up goals, planning, implementing and monitoring intervention at the different intervention levels, to support participation.

P4C-Swe intervention

Treatment as usual is provided by the Student health services that consists of a school doctor, school nurse, psychologist and counselor, and staff with special educational competence

Treatment as usual

Eligibility Criteria

Age5 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • that the school's pupils health service has access to an occupational therapist and/or special education teacher,
  • preschool class or primary school class years 1-6,
  • that school staff feel that there are pupils in class in special educational needs and/or in need of a more accessible learning environment
  • that the school principal and class teacher agree to participate in the study. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Falu kommun

Falun, 791 83, Sweden

RECRUITING

Karlskrona kommun

Karlskrona, 371 83, Sweden

RECRUITING

Kinda kommun

Kisa, 590 40, Sweden

RECRUITING

Related Publications (1)

  • Baric VB, Yngve M, Holmefur M, Feldman I, Wilder J, Johansen K, Klang N, Lidstrom H, Borgestig M. Partnering for change (P4C) in Sweden- a study protocol of a collaborative school-based service delivery model to create inclusive learning environments. BMC Public Health. 2023 Nov 10;23(1):2219. doi: 10.1186/s12889-023-17053-0.

MeSH Terms

Interventions

Therapeutics

Study Officials

  • Helene Lidström, PhD

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Borgestig, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Non randomized control
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior lecturer

Study Record Dates

First Submitted

June 22, 2022

First Posted

June 28, 2022

Study Start

February 10, 2022

Primary Completion

January 10, 2024

Study Completion

June 10, 2024

Last Updated

June 28, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations