- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05435937
Partnering for Change in Sweden - Intervention to Increase Pupils' Engagement and Participation
Partnering for Change (P4C) in Sweden - an Intersectional Collaborative Intervention to Create an Inclusive Learning Environment and Increased Conditions for Learning for Pupils at Risk of Unhealth, Exclusion and Low Academic Achievements
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maria Borgestig, PhD
- Phone Number: +46733987457
- Email: maria.borgestig@neuro.uu.se
Study Locations
-
-
-
Falun, Sweden, 791 83
- Recruiting
- Falu kommun
-
Karlskrona, Sweden, 371 83
- Recruiting
- Karlskrona kommun
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Kisa, Sweden, 590 40
- Recruiting
- Kinda kommun
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria for group of pupils are:
- 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. -
Exclusion Criteria: None
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: P4C-Swe intervention
Pupils in participating classes will receive the Partnering for change (P4C) intervention
|
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. |
|
Active Comparator: Treatment as usual
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 is provided by the Student health services that consists of a school doctor, school nurse, psychologist and counselor, and staff with special educational competence
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the Engagement Versus Disaffection With Learning: Teacher Report (EEL)
Time Frame: Baseline, four months, eleven months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the Swedish Child Health Utility 9D (CHU9D)
Time Frame: Baseline, four months, eleven months
|
The CHU9D measures HRQoL by nine-dimensions: worried, sad, pain, tiredness, annoyed, school work/homework, sleep, daily routines, and ability to join in activities.
Recall time is today, and each dimension has five severity levels e.g.
I do not feel worried today, I feel very little worried today, I feel a little worried today, I feel pretty worried today or I feel very worried today.
|
Baseline, four months, eleven months
|
|
Change in How I Feel About My School (HIFAMS)
Time Frame: Baseline, four months, eleven months
|
The HIFAMS addresses seven questions of perceived well-being in the educational setting, including satisfaction with teachers, peers, classrooms, playgrounds, the transition to school, work and school in general.
The HIFAMS uses a three-point Likert scale, where emotions are used to convey the responses Glad= a smiling face, Neutral=a neutral face, or Sad= a Sad face.
The questionnaire is suitable for children aged 4 to 12 years.
|
Baseline, four months, eleven months
|
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Change in occupational performance in school-based occupations
Time Frame: During the four months intervention period
|
Change in occupational performance, measured during observations of school-based occasion in natural context.
Measured with a rating scale (1-10) 1=no performance 10= excellent performance.
Measured once before and after implemented interventions for each identified performance break-down
|
During the four months intervention period
|
|
Change in attainment of school-based occupational performance goals
Time Frame: During the four months intervention period
|
Rated as attained, partly attained or not attained.
Measured once before and after implemented interventions for each identified performance break-down
|
During the four months intervention period
|
|
Change in School attendance
Time Frame: Baseline to eleven months
|
Statistics registration of pupils attendance in percent per week during the data collection period (eleven months).
|
Baseline to eleven months
|
|
Change in School setting interview (SSI)
Time Frame: During the four months intervention period
|
The School Setting Interview (SSI) is used only at individual level to examine the student-environment fit in a school setting.
The SSI includes 16 items concerning everyday school activities and the pupils perceived need of adjustments is documented in each item.
Each item is scored using a four-step rating scale; 4=Perfect fit, 3=Good fit, 2=<partly fit, and 1= Unfit.
Measured once before and after implemented interventions for each identified performance break-down
|
During the four months intervention period
|
|
Change in the Protocol of number of pupils with special educational needs
Time Frame: Baseline, four months, eleven months
|
A study protocol has been developed to collect data of number of pupils who have access to adjustments and or support and number of pupils in need of adjustments and or support in each class.
|
Baseline, four months, eleven months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Helene Lidström, PhD, Linkoeping University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HMV-2022-00021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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