Is a mobile health intervention (mHealth) intervention package effective in improving the parenting self-efficacy in mothers of 3-5 year old children in the Regional Director of Health Services (RDHS) Area, Colombo?

(a) Study design – Cluster Randomized Controlled Trial with two parallel arms.

(b) Study setting – Study setting will be the RDHS Area, Colombo.

(C) Study period – March 2024 to October 2024. Post intervention evaluation will be done six months after the initiation of the Intervention.

(D) Study population – All the mothers of 3 years - 5 years old children in RDHS area, Colombo.

(E) Sampling technique – It will be conducted as a cluster randomized controlled trial. A PHM area will be taken as a cluster. All the PHM areas in the Colombo RDHS area will be list down and an eligibility screening for the clusters (PHM areas) will be done.

Eligibility criteria for the clusters: The PHM areas where the population is between 3000-5000 will be taken as the inclusion criteria as the nationally recommended population per each PHM area is considered 3000 population. The PHM areas where the population exceed 5000 or where the population is below 3000 was excluded after the eligibility screening of the clusters to keep the uniformity of the clusters and to keep the cluster size a constant.

After eligibility screening of clusters, randomization will be done. Randomization: 23 clusters per arm (Intervention and control arm) - generating a random allocation sequence using a random number table. Each arm will have 23 clusters. If an adjacent two PHM areas (if the two PHM areas were within a 5Km radius) were divided into control and intervention arms during the selection, those will be excluded and another PHM area will be selected randomly from the random number table to prevent contamination of the intervention.

First the clusters will be selected for the intervention and control arms as mentioned above. Then the participants within the intervention and control arms will be selected as follows, As the cluster size is 10, Study subjects will be selected according to the inclusion and exclusion criteria from the Birth and Immunization (BI) register of each PHM area. Systematic sampling method will be used to select study subjects from the BI register. The first mother will be chosen randomly from the BI register. Sampling interval will be taken as 3. After selecting the first mother randomly from the list in the BI register, other participants will be selected with an sampling interval of 3 until the desired sample size of 10 is achieved.

(F) Study Instrument – TOPSE Parenting Evaluation tool (Tool to measure parenting self-efficacy) which has been culturally adapted and validated to Sri Lanka in the first part of this study will be used to assess the primary outcome, which is the level of Parental Self Efficacy. Primary outcome will be assessed after a period of six months.

(G) Intervention Package - The current study will use a ‘Mobile health (mHealth) Intervention Package’ to the participants of the intervention arm for a period of 6 months. Intervention package consists of a Mobile application, short messages- SMS and interactive sessions for the mothers via online platform (Zoom/ Microsoft teams).

1. Mobile Application - Consist of a gaming component and an information component on parenting self-efficacy. Participants are expected to use the mobile application including the gaming component and the information component (at least 15 minutes per day is preferable) during the intervention period of 6 months.

2. Short messages (SMS) - Participants in the intervention arm will receive a short message (SMS) daily during the intervention period of 6 months. These short messages were developed aiming the domains of parenting self-efficacy.

3. Interactive sessions for the mothers via online platform (Zoom/ Microsoft teams) - There will be Interactive Sessions for the mothers via online platform (Zoom/ Microsoft teams). The first session will be held during the first week of starting the intervention and thereafter the sessions will be held two monthly during the intervention period of 6 months. This interactive session will be done for each cluster as a group intervention (there will be 10 participants in each cluster). These interactive sessions will address all the domains of parenting self-efficacy and target on improving the domains of parenting self-efficacy (PSE). During these sessions, participants can discuss and get answers for the issues/ problems they have related to parenting self-efficacy and they can experience peer support also which is an important component in improving PSE. These interactive sessions will be conducted by the principal investigator and Public Health Midwife (PHM) of the area, a psychological counselor/ psychologist and a professional bilingual translator fluent in both Tamil and Sinhala language will also be recruited to act as facilitators for these sessions.

Control - control group will receive only the standard routine care given by the Medical Officer of Health (MOH) team.

Data analysts and outcome assessors will be blinded

• All the mothers of 3- 5 year old children in RDHS area, Colombo. • Mother’s of 3 years - 5 years old children who owns a smart phone or If the husband/partner/ family member owns a smart phone which the mother can burrow for at least 15 minutes/ day within the 6 months of intervention.

• Mothers of 3 years - 5 years old children in RDHS area, Colombo who can’t read and write. • Mothers of 3 years - 5 years old children whose children were diagnosed with a major congenital abnormalities or chronic illness. • Mother’s of 3 years - 5 years old children who do not own a smart phone is considered as an exclusion criteria but if the husband/partner/a family member owns a smart phone which the mother can burrow for at least 15 minutes/ day within the 6 months of intervention, those mother’s will not be excluded. (as the intervention is mainly based on mHealth interventions mother’s participants who does not have access to a smart phone will not be able to participate in the intervention study).