Condition category
Mental and Behavioural Disorders
Date applied
22/12/2015
Date assigned
13/01/2016
Last edited
17/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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.

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 December 2019

Who is funding the study?
1. Norrbacka-Eugenia Foundation (Sweden)
2. Foundation Sunnerdahls Disability Fund (Sweden)
3. Promobilia Foundation (Sweden)

Who is the main contact?
1. Dr Gunnel Janeslätt (scientific)
gunnel.janeslatt@ltdalarna.se
2. Mrs Sara Wallin Ahlström (public)
sara.wallin@ltdalarna.se
3. Professor Elinor Brunnberg (scientific)
4. Dr Lena Almqvist (scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gunnel Janeslätt

ORCID ID

http://orcid.org/0000-0002-4948-5331

Contact details

Centre for Clinical research Dalarna
Nissers väg 3
Falun
SE-79182
Sweden
+46 18 6118804
gunnel.janeslatt@ltdalarna.se

Type

Public

Additional contact

Mrs Sara Wallin Ahlström

ORCID ID

Contact details

Centre for Clinical research in Dalarna
Nissers väg 3
Falun
SE-791 82
Sweden
+46 73 3643235
sara.wallin@ltdalarna.se

Type

Scientific

Additional contact

Prof Elinor Brunnberg

ORCID ID

Contact details

Department of Health Care and Social Welfare
Mälardalen University
Mälardalens högskola
Eskilstuna
SE-631 05
Sweden

Type

Scientific

Additional contact

Dr Lena Almqvist

ORCID ID

http://orcid.org/0000-0001-5904-1390

Contact details

Mälardalens University
Mälardalens högskola
Västerås
SE-721 23
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

epn 2015/451

Study information

Scientific title

Evaluation of a model for early intervention using remediation and time aids for pre-school children with disabilities

Acronym

SiT

Study hypothesis

Intervention including remediation with My Time and time aids can facilitate time-processing ability in children with disabilities.

Ethics approval

Regional vetting board of Uppsala (Sweden), 09/12/2015, ref: 2015/451

Study design

Multi-centre cluster randomised trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

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

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

Phase

Drug names

Primary outcome measures

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 trial start date

21/09/2015

Overall trial end date

30/12/2019

Reason abandoned

Eligibility

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 type

Other

Age group

Child

Gender

Both

Target number of participants

Children with disabilities developmental delays, a Power analysis says at least 64 children need to be included (n=32 in each group).

Participant exclusion criteria

1. Multiple disabilities
2. Severe communication problems

Recruitment start date

15/01/2016

Recruitment end date

30/05/2018

Locations

Countries of recruitment

Sweden

Trial participating centre

Falu kommun
Barn och ungdomsförvaltningen Egnellska huset Myntgatan 45
Falun
791 83
Sweden

Sponsor information

Organisation

Centre for Clinical Research Dalarna

Sponsor details

Nissers väg 3
Falun
SE-791 82
Sweden
+46 23 18307
bjorn.ang@ltdalarna.se

Sponsor type

University/education

Website

http//ltdalarna.se/ckf

Funders

Funder type

Charity

Funder name

Norrbacka-Eugenia Foundation (Norrbacka-Eugeniastiftelsen)

Alternative name(s)

Norrbacka-Eugenia Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Sweden

Funder name

Foundation Sunnerdahls Disability Fund (Stiftelsen Sunnerdahls Handikappfond)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Promobilia Foundation (Stiftelsen Promobilia)

Alternative name(s)

Promobilia Foundation, Foundation Promobilia

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Sweden

Results and Publications

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.

Intention to publish date

31/12/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

17/05/2016: Sentence added to interventions (date stamped) 22/01/2016: Internal review