Condition category
Mental and Behavioural Disorders
Date applied
06/01/2020
Date assigned
29/01/2020
Last edited
05/02/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Physical activity can have tremendous benefits to a child’s overall wellbeing. However, children’s physical activity engagement and participation is quite low. Parents can play a key role in improving their child’s level of physical activity. Research suggests that parental behaviors (e.g., encouragement, providing transportation, facilitating enrolment) are strong correlates of child physical activity. These findings are especially true among parents of children with intellectual disabilities. Messages targeting parents have been proposed as a strategy to increase parent support. Although persuasive messaging has been shown to positively influence parent support for physical activity among children without disabilities, there is limited research to guide the development of messages targeting parents of children with intellectual disabilities. Therefore, this study is seeking to explore the effects of an online messaging intervention on physical activity support behaviors for parents of children with intellectual disabilities. The researchers have also added measures in order to assess the feasibility of the project design.

Who can participate?
Canadian parents of children with an intellectual disability (such as Down syndrome, autism or Fragile X syndrome) will be eligible to participate. Additionally, their child must be between 5-17 years of age and English must be the parent’s first language.

What does the study involve?
Participants will be randomly assigned to receive a newsletter containing varying combinations of risk information (demonstrating that children with intellectual disabilities are more likely to experience certain health issues) and gain- or loss-framed messages. Gain-framed messages highlight the benefits of engaging in physical activity whereas loss-framed messages highlight the risks of not participating. Online surveys will be completed to examine changes in parents’ physical activity support behaviors following message exposure.

What are the possible benefits and risks of participating?
No direct benefits to participants are anticipated. The researchers anticipate that findings from this study have the potential to benefit the population of parents of children with intellectual disabilities more wholly. That is, information gained in this study will advance understanding of how to optimize messages to increase physical activity engagement among children with intellectual disabilities. Further, to minimize the psychological and emotional distress experienced by participants due to the potentially stressful nature of the research questions, various provisions have been put in place. Participants may opt-out of the study at any time, researchers will monitor responses, and necessary supports will be available should research questions lead to distress. Additionally, an information sheet of physical activity and support resources will be accessible to participants.

Where is the study run from?
This study will be run from York University (Canada). Participants will be recruited through partnerships with Special Olympics and the Canadian Disability Participation Project. Due to the nature of the intervention, participants will not be limited by their geographical location as questionnaires will be completed online with SurveyMonkey.

When is the study starting and how long is it expected to run for?
July 2019 to December 2021

Who is funding the study?
York University (Canada)

Who is the main contact?
Rebecca Bassett-Gunter, rgunter@yorku.ca

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rebecca Bassett-Gunter

ORCID ID

https://orcid.org/0000-0002-3279-6707

Contact details

York University
4700 Keele St.
310 Stong College
Toronto
M3J 1P3
Canada
+1 416 736 2100 ext. 22072
rgunter@yorku.ca

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Effects of an online messaging intervention on physical activity support behaviours for parents of children with intellectual disabilities

Acronym

Study hypothesis

We have not developed a priori hypothesis because of conflicting predictions. According to the Extended Parallel Process Model, we would hypothesize that the risk information + gain-framed messages would be most effective for increasing parent support behaviours. However, the congruency effect would suggest that risk information + loss-framed messages would be most effective. Previous research has resulted in mixed findings. Accordingly, we have not made an a priori hypothesis.

Ethics approval

Pending as of 06/01/2020, York University Office of Research Ethics (Office of Research Ethics, 309 York Lanes, York University, 4700 Keele Street, North York, Ontario, M3J 1P3; ore@yorku.ca; +1 416 736 5914)

Study design

The study will use a 5 (messaging condition) x 4 (time) experimental design

Primary study design

Interventional

Secondary study design

5 x 4 experimental design

Trial setting

Internet

Trial type

Quality of life

Patient information sheet

Condition

Parents of children with intellectual disability

Intervention

Using a random numbers table, participants will be randomly assigned to one of five conditions: 1) no risk information + loss-framed messages, 2) no risk information + gain-framed messages, 3) risk information + loss-framed messages, 4) risk information + gain-framed messages, 5) control. Parents will receive information and PA messages unique to their condition.
Following randomization, participants will complete a series of questionnaires to assess a variety of theoretical predictors of parent physical activity support behaviour and child physical activity participation.
Each participant will receive then receive an e-newsletter specific to their condition.
Immediately after receiving the e-newsletter, participants will be asked to complete a follow-up questionnaire (FQ1)
Two weeks following the completion of FQ1, participants will receive a link to complete a second follow up questionnaire (FQ2)
Two months following the completion of the baseline questionnaire, participants will receive a link to complete the final follow up questionnaire (FQ3)

All questionnaires and messaging material will be administered online.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Parental physical activity support behaviours assessed by parental responses to online questionnaires at baseline, immediately post-intervention, 2 weeks and 2 months


Secondary outcome measures

1. Feasibility of the experimental design through whether it is possible to randomize parents to particular conditions and to assess the potential effects of message exposure throughout the study and after data collection
2. Acceptability of the intervention assessed by parental responses to online questionnaires at baseline, immediately post-intervention, 2 weeks and 2 months
3. Participant retention measured by withdrawal from the study at 2 months

Overall trial start date

01/07/2019

Overall trial end date

01/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Primary guardian of a child(ren) with an intellectual disability (disabilities including but not limited to; Down syndrome, autism, and Fragile X syndrome)
2. Primary guardian of a child(ren) between 5 and 17 years
3. English as first or primary language

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

None

Recruitment start date

01/02/2020

Recruitment end date

01/06/2021

Locations

Countries of recruitment

Canada

Trial participating centre

York University
4700 Keele St.
Toronto
M3J1P3
Canada

Sponsor information

Organisation

York University Office of Research Ethics

Sponsor details

309 York Lanes
York University
4700 Keele St.
North York
Toronto
M3J 1P3
Canada
+1 416 736 5914
ore@yorku.ca

Sponsor type

University/education

Website

https://research.info.yorku.ca/research-ethics/

Funders

Funder type

University/education

Funder name

York University (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in an open-access, peer-reviewed, journal.
This project will also result in conference presentations in 2020/2021.

IP sharing statement:
The data-sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

01/01/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/02/2020: The participant information sheet was uploaded as an additional file. 29/01/2020: Trial’s existence confirmed by Canadian Disability Participation Project.