Condition category
Mental and Behavioural Disorders
Date applied
22/03/2011
Date assigned
05/05/2011
Last edited
11/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://forsdata.unil.ch/fw_query_fors/re-result-2-det.fwx?htm.sel0=9927

Contact information

Type

Scientific

Primary contact

Dr Julie Page

ORCID ID

Contact details

Institute of Occupational Therapy
Health Departement
ZHAW Zurich University of Applied Sciences
Technikumstrasse 71
Winterthur
8401
Switzerland
+41 (0)58 934 6345
julie.page@zhaw.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SNF-DORE PROJEKT 113DPD6_127161/1

Study information

Scientific title

Feasibility of a single-blind randomised controlled trial of an occupational therapy intervention with children

Acronym

Children’s ADL

Study hypothesis

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

Ethics Committee of Canton St.Gallen, Switzerland, 17/11/2010, EKSG 10/008

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

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/03/2011

Overall trial end date

28/02/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

20

Participant 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

Recruitment start date

01/03/2011

Recruitment end date

28/02/2013

Locations

Countries of recruitment

Switzerland

Trial participating centre

Institute of Occupational Therapy
Winterthur
8401
Switzerland

Sponsor information

Organisation

Swiss National Science Foundation SNSF (Switzerland)

Sponsor details

Wildhainweg 3
PO Box 8232
Bern
3001
Switzerland

Sponsor type

Research organisation

Website

http://www.snf.ch/D/Seiten/default.aspx

Funders

Funder type

Research organisation

Funder name

Swiss National Science Foundation (Switzerland) (ref: SNF-DORE PROJEKT 113DPD6_127161/1)

Alternative name(s)

Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Switzerland

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes