Clinical Research Directory

Implementation Study With Embedded RCT of a Digital System of Parenting Support Within Government Services in South Africa

ParentText, a WhatsApp-based parenting support programme, is designed as a universal intervention to improve parent-child relationships (module 1) and promote child safety (module 2). The SWIFT study is an explanatory sequential time series design with an embedded randomised controlled trial. The time-series design aims to assess whether a digital parenting support programme, ParentText, can be embedded effectively into the regular services offered by the Department of Health and Wellness in the Western Cape, South Africa, and to explore factors affecting parent engagement. The embedded randomised controlled trial tests whether the second module affects sexual violence reduction against children. Participants include caregivers 18 years and older, living in South Africa, and caring for at least one child aged 2 to 17 years. The primary outcome measures of the study are both implementation 1): Assessing which of four approaches to advertising the ParentText programme leads to the highest rates of programme uptake, engagement, and completion; and programmatic: Testing the effectiveness of the additional Child Safety Module in 2) - reducing child sexual violence vulnerability, 3) - increasing child sexual violence risk planning and 4) - reducing child sexual violence exposure. The secondary outcomes assess changes in programme users' self-reported parenting behaviour in terms of 1) positive involvement, 2) positive parenting, 3) parent mental health, 4) parent support of education, 5) caregiver child/ adolescent communication, 6) online safety, 7) harsh parenting, 8) child or adolescent behavioural problems; and assessing users' experience of the 9) accessibility of the chatbot, 10) acceptability of the chatbot; and 11) adolescents' report of their sexual violence risk and safety planning communication.. In the first period of the time series design, participants will be recruited via posters, which provide a WhatsApp number for the programme, at their local clinic. Once they join, they will be provided with information on the study and be invited to consent to participate. If they consent, they will complete a baseline survey and then be able to move on to the first 5-day module. On consent to the study, participants will be placed randomly into either the group that receives the second module (intervention group) or a control group that will receive the module only after the study is completed. Both the intervention group and the control group receive the one-month and three-month surveys. In the second, third, and fourth time periods, everything remains the same except the encouragement method. In the first time period, only posters were used for recruitment. Within the second period, one month later, recruitment will be via both posters and additional encouragement from clinic staff. Clinic staff will encourage either verbally or by providing the caregiver with a flyer during their clinic visit. Throughout both these recruitment periods (1) and (2), caregivers who have completed the programme can share it on social media by posting predesigned tiles that include the joining information for the chatbot. Should our ideal sample size (4,000 participants) not be reached through these mechanisms, there will be an additional time period (3-4 weeks; time period three) during which the study team will advertise directly on Facebook. Finally, should our sample size not be reached in this third period, there will be a fourth time period of advertising that offers ZAR50 (approximately USD3) in airtime to those who sign up. This ZAR50 will be provided in sums of: ZAR15 for completing each of the baseline and one-month questionnaires, and ZAR20 for completing the three-month questionnaire. Once the three-month questionnaires are completed, participants will also be invited to a focus group discussion or telephonic interviews. Participants will be purposively selected from the group of participants who consent to the qualitative data collection phase. The focus groups will be conducted with participants residing in the Western Cape province, who completed one or both modules, and will discuss topics such as their experience of the ParentText programme, and the encouragement. For the telephonic interviews, participants will be purposely selected for interviews, looking at a) caregivers' experience of the child safety module, b) reasons for engaging/not engaging with the programme, and c) which referral services they accessed. Further, adolescents (over the age of 12 years) will be recruited via their caregivers - upon completion of the 3-month survey, parents or legal guardians will be asked to provide consent for the team to contact their adolescent to undertake a telephonic survey and, in some cases, a qualitative interview with them. Teens will complete informed assent.

CaknaStrok Education Package for Stroke Caregivers

This study evaluated the feasibility and potential effectiveness of the CaknaStrok Education Package (CEP), a culturally tailored education package developed to support informal caregivers of stroke survivors. The package consists of a mobile health application and a Malay-language caregiving guidebook covering stroke knowledge, caregiving strategies, rehabilitation, nutrition, secondary prevention and caregiver self-care. The study compared caregivers receiving the CaknaStrok Education Package in addition to usual care with those receiving usual care alone. The study assessed outcomes related to caregiving burden, quality of life and psychological well-being, as well as the feasibility of implementing the intervention within routine stroke care.

ACT Group for Family Caregivers of Stroke Survivors

The goal of this study is to evaluate the efficacy of group-based ACT intervention in improving the levels of psychological distress in caregivers of stroke survivors. The main questions it aims to answer are: 1. Does group-based ACT intervention improve the levels of psychological distress and QoL in family caregivers of stroke survivors? 2. Do the levels of psychological flexibility and experiential avoidance in family caregivers of stroke survivors mediate the outcome of the ACT Group? The researcher will compare the experimental group (i.e., participants who received group-based ACT intervention) with the control group (i.e., participants who did not receive group-based ACT intervention) to assess whether the group-based ACT intervention is effective in mitigating caregiver stress and improving caregivers' QoL. Participants in the experimental group will: 1. Receive a 5-weekly, 1.5-hour group intervention based on the ACT Model; 2. Complete study measures at pre-treatment, immediate post-treatment, and 2-month follow-up. Participants in the control group will not receive the group intervention but will complete the same study measures.

Survey for Caregivers Aged 50 and Over

There are more and more informal caregivers (PPA) in Quebec. Their increase between 2012 and 2018, according to data from the "General Social Survey - Care Given and Received," was significant, around 32%. The available data paint a typical portrait of a Quebec caregiver: (a) she is a woman, (b) aged between 50-55 years, (c) who devotes at least 3 hours of her time per week, on a regular basis, (d) to caring for an elderly parent. To this date, there is no reliable data on the health status-whether mental, physical, or social-of caregivers in Quebec. Yet this information is crucial because it affects the ability of caregivers to fulfill their role and, consequently, the stable health of the individuals they care for, allowing them to continue living at home. This situation exposes caregivers to a decline in their own health, and by extension, the health of those they care for. The fact that the typical Quebec caregiver is 50 years old or older increases the risk of health deterioration within the caregiver-care receiver pair. Indeed, age 50 is when the effects of physiological and pathological aging begin to impact the physical capacities of the elderly. Developing new practices that focus on the health characteristics of both caregivers and care receivers, in order to prevent health deterioration, is therefore a crucial step in supporting caregivers in their role and ensuring that care receivers can stay at home in good conditions for as long as possible. The issue of caregivers' health is still under-addressed in Quebec, both in the scientific literature and in population surveys. It seems that caregivers need a comprehensive evaluation of their health status (physical, mental, and social), given the significant impact caregiving has on their health. Research conducted within the Living Lab, led by Dr. Beauchet's team, has helped develop tools and questionnaires that effectively assess the frailty of individuals aged 50 and over and produce reports that raise awareness about their health status, enabling them to implement future care solutions that meet their needs. The overall objective is to assess the health status (mental, physical, social) of caregivers aged 50 and over, living in Quebec-through self-assessment to make them aware of their actual health condition and engage them in a process of self-care.