Child HealthNCT05435937
Partnering for Change in Sweden - Intervention to Increase Pupils' Engagement and Participation
A study testing Partnering for change (P4C-Swe) and Treatment as usual in people with Child Health, run by Linkoeping University at 3 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 13 years
- Conditions the study is for
- Child Health
- What is being tested?
- Partnering for change (P4C-Swe) and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 3 sitesSweden
- Study dates
- 10 Feb 2022to 10 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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. -
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites, 3 recruiting
- Recruiting
Falu kommun
Falun, 791 83
- Recruiting
Karlskrona kommun
Karlskrona, 371 83
- Recruiting
Kinda kommun
Kisa, 590 40
About this study
Official title: 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.
Read the detailed description
This project implements an innovative and intersectional intervention school-based service delivery model that addresses challenges that exist for children with special educational needs who risk school failure, exclusion and poor health because of a) the lack of accommodations and support that meet their needs in school, b) the lack of knowledge and systematic work methods to create inclusive learning environments, and c) the lack of evidence-based school interventions. Despite investments in support for children with special needs, there is a large proportion of children who do not achieve educational goals due to low engagement, attendance at school, disability or mental ill-health or poor socio-economic environments. Poor educational results may lead to inequality in society, such as exclusion from higher education and/or labour market later in life. To meet these challenges, the following study project focuses on creating inclusive learning environments by implementing the Canadian evidence and school-based service delivery model Partnering for Change (P4C) in Swedish schools. The aim of the study is to investigate the P4C´s effect on children's prerequisites for learning and children's experiences of inclusive learning environment. P4C is based on universal design for learning and facilitate earlier identification of pupils who need support, and through early intervention, with a tiered model at class, group, and individual level, increase the conditions of learning. By implementing P4C, children with or without diagnosis, will have access to accommodations that match their needs. The results of a feasibility study, with preliminary results, shows good feasibility and acceptance for P4C in Swedish schools. Participants in current study are 20 classes (400 pupils, ages 6-12 years) (intervention and control classes), class teachers, occupational therapists and special educator teachers in student health services. A non-randomized controlled intervention study design with before, after and follow up measurements will answer how effective P4C is for children.
- Conditions
- Child Health
- Being tested
- Partnering for change (P4C-Swe), Treatment as usual
- Keywords
- Disabled Children, Special educational needs, Partnering for change, Universal design for learning, Participation, Tiered intervention model, Inclusive learning environment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partnering for change (P4C-Swe)Behavioural
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.
Treatment as usualBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| P4C-Swe intervention | Experimental | Pupils in participating classes will receive the Partnering for change (P4C) intervention Receives: 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 Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, four months, eleven months
Secondary outcomes (7)
Change in the Swedish Child Health Utility 9D (CHU9D)
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.
Measured: Baseline, four months, eleven months
Change in How I Feel About My School (HIFAMS)
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.
Measured: Baseline, four months, eleven months
Change in occupational performance in school-based occupations
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
Measured: During the four months intervention period
Change in attainment of school-based occupational performance goals
Rated as attained, partly attained or not attained. Measured once before and after implemented interventions for each identified performance break-down
Measured: During the four months intervention period
Change in School attendance
Statistics registration of pupils attendance in percent per week during the data collection period (eleven months).
Measured: Baseline to eleven months
Change in School setting interview (SSI)
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
Measured: During the four months intervention period
Change in the Protocol of number of pupils with special educational needs
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.
Measured: Baseline, four months, eleven months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start10 Feb 2022
- Primary completion10 Jan 2024 (estimated)
- Study completion10 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child HealthStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non randomized control
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Uppsala University, Örebro University, Sweden, Stockholm University
- Responsible party
- Principal investigator, Helene Lidstrom, Linkoeping University
- Investigators
- Helene Lidström, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435937
- Sponsor's protocol ID
- HMV-2022-00021
- Status last verified
- Jun 2022
- First submitted
- 22 Jun 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37950243
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05435937
- Acronym / sponsor ID
- HMV-2022-00021
- Conditions
- Child Health
- Keywords
- Disabled Children, Special educational needs, Partnering for change, Universal design for learning, Participation, Tiered intervention model, Inclusive learning environment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Uppsala University, Örebro University, Sweden, Stockholm University
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 10 Jan 2024 (estimated)
- Study completion
- 10 Jun 2024 (estimated)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This project implements an innovative and intersectional intervention school-based service delivery model that addresses challenges that exist for children with special educational needs who risk school failure, exclusion and poor health because of a) the lack of accommodations and support that meet their needs in school, b) the lack of knowledge and systematic work methods to create inclusive learning environments, and c) the lack of evidence-based school interventions. Despite investments in support for children with special needs, there is a large proportion of children who do not achieve educational goals due to low engagement, attendance at school, disability or mental ill-health or poor socio-economic environments. Poor educational results may lead to inequality in society, such as exclusion from higher education and/or labour market later in life. To meet these challenges, the following study project focuses on creating inclusive learning environments by implementing the Canadian evidence and school-based service delivery model Partnering for Change (P4C) in Swedish schools. The aim of the study is to investigate the P4C´s effect on children's prerequisites for learning and children's experiences of inclusive learning environment. P4C is based on universal design for learning and facilitate earlier identification of pupils who need support, and through early intervention, with a tiered model at class, group, and individual level, increase the conditions of learning. By implementing P4C, children with or without diagnosis, will have access to accommodations that match their needs. The results of a feasibility study, with preliminary results, shows good feasibility and acceptance for P4C in Swedish schools. Participants in current study are 20 classes (400 pupils, ages 6-12 years) (intervention and control classes), class teachers, occupational therapists and special educator teachers in student health services. A non-randomized controlled intervention study design with before, after and follow up measurements will answer how effective P4C is for children.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non randomized control
| Arm | Type | Receives |
|---|---|---|
| P4C-Swe intervention | Experimental | Behavioral: Partnering for change (P4C-Swe)Pupils in participating classes will receive the Partnering for change (P4C) intervention |
| Treatment as usual | Active comparator | Behavioral: Treatment as usualTreatment 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 |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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. -
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partnering for change (P4C-Swe)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. | Behavioural | P4C-Swe intervention |
| Treatment as usualTreatment 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 | Behavioural | Treatment as usual |
Primary outcome
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.
7 secondary outcomes
Change in the Swedish Child Health Utility 9D (CHU9D)
Time frame: Baseline, four months, eleven months
Change in How I Feel About My School (HIFAMS)
Time frame: Baseline, four months, eleven months
Change in occupational performance in school-based occupations
Time frame: During the four months intervention period
Change in attainment of school-based occupational performance goals
Time frame: During the four months intervention period
Change in School attendance
Time frame: Baseline to eleven months
Change in School setting interview (SSI)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Derived from this study: PubMed 37950243Baric 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helene Lidström, PhD principal investigator
Linkoeping University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partnering for change (P4C-Swe) and Treatment as usual in people with Child Health, run by Linkoeping University at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Borgestig, PhD (+46733987457, maria.borgestig@neuro.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Engagement Versus Disaffection With Learning: Teacher Report (EEL) (time frame: Baseline, four months, eleven months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05435937, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.