Can support in time help pre-school children in developing time-processing ability?
| ISRCTN | ISRCTN85136134 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85136134 |
| Secondary identifying numbers | epn 2015/451 |
- Submission date
- 22/12/2015
- Registration date
- 13/01/2016
- Last edited
- 07/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Many children who suffer from learning disabilities such as intellectual disability (ID), autism or ADHD, are reported to have problems with managing their time effectively (time-processing ability, TPA). The difference in the TPA of special needs children and that of typically developing children is thought to become more pronounced as they get older. Despite this, there is currently no real way to help improve TPA in pre-school age children. Support in Time is a programme which has been developed to help improve TPA in young children. It involves the “My Time” method, which uses techniques such as the QuaterHourWatch principle, which marks the time distance to an activity/event in dots (each representing 15 minutes). This calculates the “distance” to a certain time without the user having to work it out themselves. The aim of this study is to find out whether the Support in Time programme can help children with special needs to improve their TPA.
Who can participate?
Children aged between 5 and 6 with learning disability or developmental delay who attend a participating pre-school. Typically Developing children who attend a participating pre-school were included from 02/09/2019.
What does the study involve?
Participating pre-schools are randomly allocated to one of two groups. Children attending the pre-schools in the first group (intervention group) begin the “Support in Time” programme, which lasts for 8 weeks. This involves teaching children the “My Time” method using time aids, such as a quarter hour watch (measuring time intervals with dots), time log, memo day planner and picture schedule of the week. Children attending the pre-schools in the second group (control group) continue as normal for the first 8 weeks of the study. At the start of the study, and then again after the intervention group have completed the 8 week programme, children in both groups complete interviews and questionnaires in order to assess their time-processing ability. Following this, the control group completes the 8 week programme. These children are then assessed in order to compare their time-processing ability now to their previous result.
What are the possible benefits and risks of participating?
Children are likely to enjoy the tasks in this study and may benefit from having more control over their time. Risks of participating are minimal; however it is possible that the study may make children more aware of their own limitations which could harm their self-esteem.
Where is the study run from?
A number of pre-schools in the Falun municipality (Sweden)
When is the study starting and how long is it expected to run for?
September 2015 to May 2020
Who is funding the study?
1. Norrbacka-Eugenia Foundation (Sweden)
2. Foundation Sunnerdahls Disability Fund (Sweden)
3. Promobilia Foundation (Sweden)
4. Center for Clinical Research in Dalarna (Sweden)
Who is the main contact?
1. Dr Gunnel Janeslätt (scientific)
gunnel.janeslatt@regiondalarna.se
2. Mrs Sara Wallin Ahlström (public)
sara.wallin@regiondalarna.se
3. Dr Lena Almqvist
lena.almqvist@mdh.se
4. Dr Catharina Gustavsson (scientific)
catharina.gustavsson@regiondalarna.se
5 Dr Maria Harder (scientific)
maria.harder@mdh.se
Contact information
Scientific
Centre for Clinical research Dalarna
Nissers väg 3
Falun
SE-79182
Sweden
 ORCID ID |
0000-0002-4948-5331 |
|---|---|
| Phone | +46 18 6118804 |
| gunnel.janeslatt@regiondalarna.se |
Public
Centre for Clinical research in Dalarna
Nissers väg 3
Falun
SE-791 82
Sweden
| Phone | +46 73 3643235 |
|---|---|
| sara.wallin@regiondalarna.se |
Scientific
Mälardalens University
Mälardalens högskola
Västerås
SE-721 23
Sweden
| ORCID ID |
0000-0001-5904-1390 |
|---|
Scientific
Center for Clinical Research Dalarna
Uppsala University
Nissers vag 3
SE-79182 Falun
Uppsala
SE-79182
Sweden
| ORCID ID |
0000-0002-8709-4446 |
|---|---|
| Phone | +46 (0)730-818201 |
| catharina.gustavsson@regiondalarna.se |
Scientific
School of Health Care and Social Welfare
Mälardalens Högskola
Gurksaltargatan 9
72218 Västerås
Västerås
SE-72218
Sweden
| ORCID ID |
0000-0003-1740-8072 |
|---|---|
| Phone | +4621-1011612 |
| maria.harder@mdh.se |
Study information
| Study design | Randomized controlled trial using a waiting list design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | School |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet (only available in Swedish) |
| Scientific title | Evaluation of a model for early intervention using remediation and time aids for pre-school children with disabilities |
| Study acronym | SiT |
| Study hypothesis | Intervention including remediation with My Time and time aids can facilitate time-processing ability in children with disabilities. |
| Ethics approval(s) | Current ethics approval as of 25/05/2020: 1. Approved 09/12/2015, Regional vetting board of Uppsala (Sweden), ref: 2015/451 2. Inclusion of the additional cohort of typically developing children approved 19/08/2019, Regional vetting board of Uppsala (Sweden), ref: 2019-04301 Previous ethics approval: Regional vetting board of Uppsala (Sweden), 09/12/2015, ref: 2015/451 |
| Condition | Childhood disability and developmental delay |
| Intervention | Each school is initially assigned as being in the control group or intervention group. After baseline assessments have been made (first two weeks of study), the children in the intervention group undergo the "My Time" intervention for 8 weeks and the children in the control group carry on as normal. After this 8 week period, full data collection will be done from both groups. The control group children now receive the intervention (as no more data collection will be made in the intervention group it is not a full randomised cross over design). The last two weeks of the study involves taking more post interventional assessments from only the children in the first control group. For the second data collection, external trained occupational therapists will be engaged to do the assessment, to obtain blinding as far as possible.(sentence added 17/05/2016) The intervention involves the "Support in Time" model, which incorporates the "My Time" method and time aids (The Quarter-hour watch, time log, Memo day Planner and Picture schedule of the week). "My Time" is a method developed by the National Agency for Special Needs Education and Schools (Swedish SPSM), for systematic training of Time-Processing Ability (TPA) in children based on current knowledge in time-processing ability and on "the quarter-hour principle". The aim of My Time is to provide multiple options to collect experiences of duration of daily- life activities all labelled in the unity of quarter-hour dots. The method My Time includes to visualise time (using the quarter-hour watch, timelog and Memo day planner), document time (using referens shred and a timebook), process and discuss (using the activities documented in the time book as a reference, Memo day planner, picture schedule). The base to understand time starts with building a sense of duration of time in daily activities. When this is done at the child's level of abstraction it's possible to fill the reference memory with experiences of time duration in daily activities. |
| Intervention type | Mixed |
| Primary outcome measure | Time-processing ability (TPA) is measured using the Kit for Assessment of Time-processing ability (KaTid) at baseline, after the 8 week intervention period and then a third data collection for the control group after their completion of the 8 week intervention. |
| Secondary outcome measures | Everyday functioning is measured using the Time-Parent scale, Autonomy scale and ABAS-II questionnaires at baseline, after the 8 week intervention period and then a third data collection for the control group after their completion of the 8 week intervention. |
| Overall study start date | 21/09/2015 |
| Overall study end date | 30/05/2020 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 6 Years |
| Sex | Both |
| Target number of participants | Target enrolment of children with disabilities, n=75; Target enrolment of typically developing children, n= 76 |
| Total final enrolment | 151 |
| Participant inclusion criteria | Current participant inclusion criteria as of 25/05/2020: 1. Either 1.1. Children with disabilities like CP, MMC, AST, ADHD, ID and developmental delays, or 1.2. Typically Developing children (included as of 02/09/2019) 2. Aged 5 or 6 years during the year of the intervention Previous participant inclusion criteria: 1. Children with disabilities like CP, MMC, AST, ADHD, ID and developmental delays 2. Aged 5 or 6 years during the year of the intervention |
| Participant exclusion criteria | 1. Multiple disabilities 2. Severe communication problems |
| Recruitment start date | 15/01/2016 |
| Recruitment end date | 30/12/2019 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Egnellska huset
Myntgatan 45
Falun
791 83
Sweden
Sponsor information
University/education
Nissers väg 3
Falun
SE-791 82
Sweden
| Phone | +46 23 18307 |
|---|---|
| bjorn.ang@ltdalarna.se | |
| Website | http//ltdalarna.se/ckf |
"ROR" |
https://ror.org/03qp8ma69 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Norrbacka-Eugenia Foundation
- Location
- Sweden
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- Sweden
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Promobilia Foundation, Foundation Promobilia
- Location
- Sweden
Government organisation / Local government
- Alternative name(s)
- Center for Clinical Research Dalarna, CKF
- Location
- Sweden
Results and Publications
| Intention to publish date | 01/02/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Current publication and dissemination plan as of 25/05/2020: Planned publication of several manuscripts in peer-reviewed journals, in addition to planned presentation of results at national and international conferences. Data from Typically developing children will be presented in one separate publication. Previous publication and dissemination plan: Planned publication of several manuscripts in peer-reviewed journals, in addition to planned presentation of results at national and international conferences. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available as the ethical approval does not include sharing data with external researchers. The information was not included in the informed consent signed by the participants. |
Editorial Notes
07/12/2022: The study design was changed from 'Multi-centre cluster randomised trial' to 'Randomized controlled trial using a waiting list design'.
26/07/2022: The intention to publish date was changed from 31/12/2023 to 01/02/2023.
14/07/2021: The overall trial end date has been changed from 30/06/2020 to 30/05/2020 and the plain English summary has been updated accordingly.
09/07/2020: The following changes were made to the trial record:
1. The target number of participants was changed from 'Target enrolment of children with disabilities, n=74; Target enrolment of typically developing children, n=93' to 'Target enrolment of children with disabilities, n=75; Target enrolment of typically developing children, n= 76'.
2. The total final enrolment number was changed from 61 to 151.
3. The recruitment end date was changed from 30/06/2020 to 30/12/2019.
4. The overall trial end date was changed from 30/12/2021 to 30/06/2020.
27/05/2020: The following changes have been made:
1. The target number of participants has been changed from "Children with disabilities developmental delays, a Power analysis says at least 64 children need to be included (n=32 in each group)." to "Target enrolment of children with disabilities, n=74; Target enrolment of typically developing children, n=93".
2. The total target enrolment has been changed from "64" to "167".
25/05/2020: The following changes have been made:
1. The total final enrolment number has been added.
2. The ethics approval has been updated.
3. The secondary study design has been changed from "Cluster randomised trial" to "Randomised controlled trial".
4. The participant inclusion criteria have been updated.
5. The publication and dissemination plan has been updated.
6. The plain English summary has been updated to reflect the changes above and a trial contact was added to this field.
11/09/2019: The IPD sharing statement was added.
10/09/2019: Contact details updated.
28/08/2018: Dr Catharina Gustavsson and Dr Maria Harder have been added as scientific contacts.
08/08/2018: The following changes have been made:
1. The recruitment end date has been changed from 30/05/2018 to 30/06/2020.
2. The overall trial end date has been changed from 30/12/2019 to 30/12/2021.
3. The intention to publish date has been changed from 31/12/2018 to 31/12/2023.
4. Dalarna Clinical Research Center has been added as a funder.
5. The plain English summary has been updated to include the additional funder.
17/05/2016: Sentence added to interventions (date stamped)
22/01/2016: Internal review
