Improving everyday doing of children with mild disabilities: a feasibility study of an occupational therapy intervention
| ISRCTN | ISRCTN55222180 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55222180 |
| Secondary identifying numbers | SNF-DORE PROJEKT 113DPD6_127161/1 |
- Submission date
- 22/03/2011
- Registration date
- 05/05/2011
- Last edited
- 11/12/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Julie Page
Scientific
Scientific
Institute of Occupational Therapy
Health Departement
ZHAW Zurich University of Applied Sciences
Technikumstrasse 71
Winterthur
8401
Switzerland
| Phone | +41 (0)58 934 6345 |
|---|---|
| julie.page@zhaw.ch |
Study information
| Study design | Feasibility study of a multi-centre single-blind randomised controlled trial (with balanced randomisation [1:1]) with a cross-over design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Feasibility of a single-blind randomised controlled trial of an occupational therapy intervention with children |
| Study acronym | Childrens ADL |
| Study objectives | Current hypothesis as of 11/12/2013: How feasible is an RCT for evaluating the effectiveness of a client-centered, activity-based occupational therapy intervention with children with mild disabilities in Switzerland? Previous hypothesis: Does a client-centred, activity-based intervention result in enhanced objective and subjective quality of task performance in children with mild disabilities? On 11/12/2013 the following changes were made to the trial record: 1. The public title was changed from 'Improving everyday doing of children with mild disabilities: an occupational therapy intervention study' to 'Improving everyday doing of children with mild disabilities: a feasibility study of an occupational therapy intervention ' 2. The scientific title was changed from 'Effectiveness of client centered, activity based occupational therapy intervention on daily life task performance of children with mild disabilities' to 'Feasibility of a single-blind randomised controlled trial of an occupational therapy intervention with children' 3. The study design was changed from 'Randomised single-blind cross-over study' to 'Feasibility study of a multi-centre single-blind randomised controlled trial (with balanced randomisation [1:1]) with a cross-over design' 4. The anticipated end date was changed from 30/06/2012 to 28/02/2013 5. The target number of participants was changed from 100 to 20 |
| Ethics approval(s) | Ethics Committee of Canton St.Gallen, Switzerland, 17/11/2010, EKSG 10/008 |
| Health condition(s) or problem(s) studied | Children with mild disabilities |
| Intervention | 1. The occupational therapy intervention is according to the Occupational Therapy Intervention Process Modell (OTIPM, Fisher, 2009) i.e. a client-centred and occupation-based 2. Participating occupational therapists have received special three day training in this approach as well as monthly supervision and support by the research team 3. There will be weekly sessions of occupational therapy, during 15 weeks 4. Control-group: no treatment during a 15 weeks control phase |
| Intervention type | Other |
| Primary outcome measure | The Assessment of Motor and Process Skills (AMPS) (Fisher, 2010) is used as the objective outcome measure ["outsider" view of observed activities of daily living (ADL) performance] at baseline, three and six month. |
| Secondary outcome measures | As a second, subjective measure (insider view of perceived performance) the Canadian Occupational Performance Measure (COPM, Law, 2009) is used with the children and their parents, at baseline, three and six month. |
| Overall study start date | 01/03/2011 |
| Completion date | 28/02/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 9 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | 1. Children aged 5 to 9 years, either sex 2. Who have been newly diagnosed with attention deficit hyperactivity disorder (ADHD), developmental coordination disorder (DCD) and/or learning disability, according to of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria 3. Average or above average intellectual capacity 4. Occupational therapy is prescribed |
| Key exclusion criteria | 1. Other neurological disorders, such as traumatic brain injury or cerebral palsy 2. Any other pervasive developmental disorder, including autism 3. Mental health problems, such as childhood depression 4. Mental retardation/intellectual disabilities |
| Date of first enrolment | 01/03/2011 |
| Date of final enrolment | 28/02/2013 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Institute of Occupational Therapy
Winterthur
8401
Switzerland
8401
Switzerland
Sponsor information
Swiss National Science Foundation SNSF (Switzerland)
Research organisation
Research organisation
Wildhainweg 3
PO Box 8232
Bern
3001
Switzerland
| Website | http://www.snf.ch/D/Seiten/default.aspx |
|---|---|
"ROR" |
https://ror.org/00yjd3n13 |
Funders
Funder type
Research organisation
Swiss National Science Foundation (Switzerland) (ref: SNF-DORE PROJEKT 113DPD6_127161/1)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Schweizerischer Nationalfonds, Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerische Nationalfonds, SNF, SNSF, FNS
- Location
- Switzerland
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
