Health and physical activity among children with intellectual disabilities
| ISRCTN | ISRCTN83755370 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83755370 |
- Submission date
- 06/01/2020
- Registration date
- 29/01/2020
- Last edited
- 13/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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 aimed to explore the effects of an online messaging intervention on physical activity support behaviours for parents of children with intellectual disabilities.
Who can participate?
Parents, legal guardians, or primary caregivers of a child, youth, or young adult with an intellectual disability (e.g., Down syndrome, fetal alcohol spectrum disorder, or cerebral palsy) or autism were eligible to participate. Additionally, participants must have been fluent in English and resided in Canada.
What does the study involve?
Participants were 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 were completed to examine changes in parents’ physical activity support behaviours following message exposure.
What are the possible benefits and risks of participating?
No direct benefits were anticipated for the participants. 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 were put in place. Participants were able to opt-out of the study at any time, researchers monitored responses, and necessary supports were available should research questions lead to distress. Additionally, an information sheet of physical activity and support resources was accessible to participants.
Where is the study run from?
This study ran from York University (Canada). Participants were recruited through partnerships with community-based organizations (e.g., Special Olympics), social media advertisements, emails to participants from previous studies, and word of mouth. Due to the nature of the intervention, participants were not limited by their geographical location as questionnaires were 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
Contact information
Scientific
York University
4700 Keele St.
310 Stong College
Toronto
M3J 1P3
Canada
 ORCID ID |
0000-0002-3279-6707 |
|---|---|
| Phone | +1 416 736 2100 ext. 22072 |
| rgunter@yorku.ca |
Study information
| Study design | Current study design as of 18/08/2023: A four (time) x three (risk) x three (frame) repeated measures experimental design was employed _____ Previous study design: The study will use a 5 (messaging condition) x 4 (time) experimental design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual, Telephone |
| Study type | Quality of life |
| Participant information sheet | ISRCTN83755370_PIS_V1.0_28Jan2020.pdf |
| Scientific title | Physical activity support behaviours among parents of children with intellectual disabilities: Evaluating an online messaging intervention |
| Study objectives | Current study hypothesis as of 18/08/2023: Due to conflicting findings in the existing literature and the novel implementation of this messaging approach among parents of children and youth with intellectual disabilities, a priori hypotheses were not generated regarding effects of the messaging intervention on message perceptions, extended parallel process model constructs, and parental support for physical activity. _____ Previous 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(s) |
Approved 04/02/2020, York University Office of Research Ethics (Office of Research Ethics, 309 York Lanes, York University, 4700 Keele Street, North York, Ontario, M3J 1P3, Canada; +1 416 736 5914; ore@yorku.ca), ref: e2020-028 |
| Health condition(s) or problem(s) studied | Current condition as of 18/08/2023: Parents of children and youth with intellectual disabilities ______ Previous condition: Parents of children with intellectual disability |
| Intervention | Current interventions as of 18/08/2023: In the screening stage, participants completed an eligibility assessment and a demographics questionnaire. Participants self-identified their children’s primary disability in the eligibility assessment. Follow-up phone calls were performed to confirm eligibility. Eligible participants were assigned to one of five conditions: 1) risk information + gain-framed messages, 2) risk information + loss-framed messages, 3) no risk information + gain-framed messages, 4) no risk information + loss-framed messages, or 5) control. Assignment of participants to each condition was performed randomly and in a single-blind manner. Next, participants completed a series of questionnaires to assess a variety of theoretical predictors of parent physical activity support behaviour and child physical activity participation. Participants completed a child characteristics questionnaire, followed by a baseline questionnaire measuring extended parallel process model constructs and parental support for physical activity. Participants then read an online newsletter that corresponded with their assigned condition. Immediately after reading the newsletter, participants completed follow-up questionnaire one. This questionnaire was similar to the baseline, with the addition of manipulation checks and measures pertaining to message perceptions. Two weeks following the baseline questionnaire, participants completed follow-up questionnaire two, which contained measures of extended parallel process model constructs and parental support for physical activity. Lastly, two months post-baseline, participants completed follow-up questionnaire three, which was identical to follow-up questionnaire two. _____ Previous interventions: 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 |
| Primary outcome measure | Current primary outcome measure as of 18/08/2023: Parental support behaviours assessed by parental responses to online questionnaires at baseline, immediately post-intervention, two weeks and two months _____ Previous 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 | Current secondary outcome measures as of 18/08/2023: 1. Messaging manipulations measured immediately post-intervention 2. Message perceptions measured immediately post-intervention 3. Extended parallel process model constructs measured at baseline, immediately post-intervention, two weeks and two months _____ Previous 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 study start date | 01/07/2019 |
| Completion date | 01/12/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 80 |
| Key inclusion criteria | Current inclusion criteria as of 18/08/2023: 1. Parents, legal guardians, or primary caregivers of a child, youth, or young adult with an intellectual disability (e.g., Down syndrome, fetal alcohol spectrum disorder, or cerebral palsy) or autism 2. Fluency in English 3. Residence in Canada _____ Previous 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 |
| Key exclusion criteria | None |
| Date of first enrolment | 01/05/2020 |
| Date of final enrolment | 01/12/2021 |
Locations
Countries of recruitment
- Canada
Study participating centre
Toronto
M3J 1P3
Canada
Sponsor information
University/education
309 York Lanes
York University
4700 Keele St.
North York
Toronto
M3J 1P3
Canada
| Phone | +1 416 736 5914 |
|---|---|
| ore@yorku.ca | |
| Website | https://research.info.yorku.ca/research-ethics/ |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in an open-access, peer-reviewed, journal. Conference presentation in October 2022. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Rebecca Bassett-Gunter (rgunter@yorku.ca) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V1.0 | 28/01/2020 | 05/02/2020 | No | Yes |
| Participant information sheet | version 2.0 | 18/08/2023 | No | Yes |
Additional files
- ISRCTN83755370_PIS_V1.0_28Jan2020.pdf
- uploaded 05/02/2020
- ISRCTN83755370_PIS_V2.0.pdf
Editorial Notes
13/12/2023: The intention to publish date was changed from 01/12/2023 to 01/06/2024.
18/08/2023: The following changes were made to the trial record:
1. The participant information sheet v2.0 was uploaded as an additional file.
2. The scientific title was changed from "Effects of an online messaging intervention on physical activity support behaviours for parents of children with intellectual disabilities" to "Physical activity support behaviours among parents of children with intellectual disabilities: Evaluating an online messaging intervention".
3. The study hypothesis was changed.
4. The ethics approval was added.
5. The study design was changed.
6. The secondary study design was changed from 5 x 4 experimental design to Randomised controlled trial.
7. The study setting 'Telephone' was added.
8. The condition was changed.
9. The interventions were changed.
10. The primary outcome measure was changed.
11. The secondary outcome measures were changed.
12. The inclusion criteria were changed.
13. The total final enrolment was added.
14. The recruitment start date was changed from 01/02/2020 to 01/05/2020.
15. The recruitment end date was changed from 01/06/2021 to 01/12/2021.
16. The plain English summary was updated to reflect these changes.
17. The intention to publish date was changed from 01/01/2021 to 01/12/2023.
18. The participant level data sharing statement was added.
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.
