Is Cognitive Orientation to daily Occupational Performance (CO-OP) more effective to achieve personal goals than conventional habilitation services for children with cerebral palsy or spina bifida?
| ISRCTN | ISRCTN12888658 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12888658 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsors | Queen Silvia Children's Hospital (Sweden), Habilitering och Hälsa VG-region, Habiliteringen Halland, Habilitering & Hälsa |
| Funders | Vastra Gotaland regional research fund, Norrbacka-Eugeniastiftelsen, Sahlgrenska University Hospital ALF, The Foundation Sunnerdahl Handikapp Fund, Josef och Linnea Carlssons Foundation, Regional research fund Habitation & Health, Vastra Gotalandsregionen, Folke Bernadotte Foundation, RBU Research Foundation |
- Submission date
- 04/02/2020
- Registration date
- 12/02/2020
- Last edited
- 10/06/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Research shows that people with Cerebral Palsy (CP) and Spina Bifida (SP) have difficulties governing their own lives due to executive dysfunctions (problem-solving, planning, initiation). Cognitive Orientation in Daily Occupational Performance (CO-OP) has been shown to enhance self-efficacy and executive functions in young adults with CP or SB through the enablement of self-chosen goals by learning of strategy-use and metacognitive thinking. This study aims to investigate the efficacy of CO-OP for children and adolescents with CP or SB compared to conventional habilitation services.
Who can participate?
Children and adolescents 9 to 16 year olds with cerebral palsy (with fairly good ability to use their hands) or spina bifida (with and without hydrocephalus) who:
1. Have experienced problems performing or organizing activities due to difficulties with initiative, planning, problem-solving and decision-making process
2. Go to school in compulsory school in the mainstream curriculum and communicate in Swedish
3. Are capable of formulating their own goals
What does the study involve?
The children and adolescents are randomly allocated to either a 10-week intervention with CO-OP or a waitlist group with ordinary habilitation services (control group). After 10 weeks the groups switch so the children and adolescents in the waitlist group start a COOP intervention. Four goals are identified by each child both in the intervention group and the control group (one remains untrained to study generalization and transfer to other environments or new situations). Investigations are done before and directly after the intervention and 3 months after.
What are the possible benefits and risks of participation?
The goal of this project is partly to be able to achieve the goals participants set themselves to cope with everyday activities by learning/improving their problem-solving ability and learning to use strategies. If any of these treatment effects are achieved, it is likely to mean increased independence in various activities, less dependence on relatives and assistants, and increased participation in everyday life as well as increased self-efficacy. The risks of participating in the project are very small. There is a small risk that those who participate may experience a feeling of failure, but the method is based on finding ways to achieve their goals, so the responsible occupational therapist will try to prevent this.
Where is the study run from?
This study is a multicenter study in four different regions in Sweden:
1. Regional Rehabilitation Centre for Children and Adolescents, Queen Silvia Children's Hospital
2. Habilitering & Hälsa, Region Stockholm
3. Habilitering & Hälsa Västra Götalandsregion
4. Habiliteringen Halland
5. Region Gävleborg, Barn- och ungdomshabilitering
When is the study starting and how long is it expected to run for?
April 2015 to June 2020
Who is funding the study?
1. Vastra Gotaland regional research fund
2. Norrbacka-Eugenia Foundation
3. Sahlgrenska University Hospital ALF
4. The Foundation Sunnerdahl Handikapp Fund
5. Josef och Linnea Carlssons Foundation
6. Regional research fund Habitation & Health, Vastra Gotalandsregionen
7. Folke Bernadotte Foundation
8. RBU Research Foundation
Who is the main contact?
Dr Marie Peny-Dahlstrand
marie.peny-dahlstrand@neuro.gu.se
Contact information
Scientific
Queen Silva Children's hospital, Regional Rehabilitation Centre
Box 210 62
Göteborg
SE 41804
Sweden
 ORCID ID |
0000-0002-6026-1136 |
|---|---|
| Phone | +46 (0)314347602 |
| marie.peny-dahlstrand@neuro.gu.se |
Scientific
Karolinska Institutet, Departement for neurobiology, care sciences, and society
Division of Occupational Therapy
Fack 23200
Huddinge
SE-14183
Sweden
| ORCID ID |
0000-0002-3746-1295 |
|---|---|
| Phone | +46 (0)852483830 |
| ann-marie.ohrvall@ki.se |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional multicentre randomized cross over trial |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | Is Cognitive Orientation to daily Occupational Performance (CO-OP) more effective to achieve personal goals than conventional habilitation services for children with cerebral palsy or spina bifida: a randomised control trial |
| Study acronym | CO-OP in children with CP or Spina Bifida |
| Study objectives | The project is based on four hypotheses: 1. CO-OP is more effective than conventional habilitation services in order to reach self-identified activity goals 2. CO-OP intervention to a higher extent leads to the achievement of an untrained goal than conventional habilitation services (transfer effect) 3. With CO-OP intervention self-rated participation in society (estimated by the person himself) increases more than with conventional habilitation 4. CO-OP intervention increases executive ability to a greater extent than conventional habilitation |
| Ethics approval(s) | Approved 19/05/2016, Regional Ethics Review Board in Gothenburg (Regionala etikprövningsnämnden i Göteborg, Box 401 405 30, Göteborg, Sweden; Tel: +46 (0)3178621), Dnr: 393-16, Ref. No. 393-16 |
| Health condition(s) or problem(s) studied | Cerebral palsy or spina bifida |
| Intervention | The children and adolescents will be allocated to either a 10-weeks intervention with CO-OP or waitlist group with ordinary habilitation services (control group). After 10 weeks the groups will switch so the children and adolescents in the waitlist group will start a COOP intervention. Four goals were identified by each child both in the intervention group and the control group (one remains untrained to study generalization and transfer to other environments or new situations). Investigations will be done before and directly after the intervention and 3 months after. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Self-rated goal attainment measured with Canadian Occupational Performance Measure (COPM) in both groups (both treatment and waitlist-control) at goalsetting before the treatment/control period, and directly after the period. COPM also used as follow up at 3 months after the treatment period for the treatment group |
| Key secondary outcome measure(s) |
1. Self-rated competence and value of everyday-activities are rated with The Child Occupational Self- Assessment-Swedish version (COSA-S) by the participants (in both groups) before, directly after and for treatment group 3 months post-intervention |
| Completion date | 13/06/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 9 Years |
| Upper age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 46 |
| Key inclusion criteria | Children and adolescents with cerebral palsy (MACS I-III GMFCS I-IV) or spina bifida (with or without hydrocephalus), aged 9-16 years (in the year of enrolment) who have: 1. Experienced problems (self-perceived or experienced by parents) to perform or organize activities due to difficulties with initiative, planning, problem-solving and decision-making process 2. Goes to school in compulsory school in the mainstream curriculum and communicates in Swedish 3. Capability to formulate own goals |
| Key exclusion criteria | 1. Children who communicate with Augmentative and Alternative Communication (ACC) or are unable to communicate in Swedish 2. Going to compulsory school in special education for intellectual disability curriculum in time of enrolment |
| Date of first enrolment | 01/06/2017 |
| Date of final enrolment | 30/08/2019 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Göteborg
418 04
Sweden
Stockholm
104 31
Sweden
Göteborg
411 18
Sweden
Halmstad
30185
Sweden
Gävle
806 33
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Marie Peny-Dahlstrand (marie.peny-dahlstrand@vgregion.se). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 04/03/2022 | 10/06/2022 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/06/2022: The following changes have been made:
1. Publication reference added.
2. The scientific contact's details have been updated.
30/12/2021: The intention to publish date has been changed from 31/12/2021 to 30/06/2022.
07/07/2021: The intention to publish date has been changed from 01/07/2021 to 31/12/2021.
28/06/2021: The intention to publish date was changed from 31/12/2020 to 01/07/2021.
17/07/2020: The following changes were made to the trial record:
1. The overall end date was changed from 01/06/2020 to 13/06/2020.
2. The intention to publish date was changed from 31/10/2020 to 31/12/2020.
3. The total final enrolment was added.
12/02/2020: Trial's existence confirmed by Regional Ethics Review Board in Gothenburg.
