Clinical trial NCT05003518: ParentText User Engagement and Effectiveness Study
Official title: ParentText User Engagement and Effectiveness Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Engagement
Positive Parenting
Child Maltreatment
Intimate Partner Violence
Keywords: Engagement
Chatbot
Digital Behaviour Change Intervention
Parenting Intervention
Optimisation
Positive Parenting
Child Maltreatment
Intimate Partner Violence
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: IDEMS International
name: UNICEF South Africa
name: UNICEF Malaysia
name: UNICEF Sri Lanka
name: UNICEF Jamaica
name: UNICEF Philippines
name: Health Promotion Bureau, Sri Lanka
name: Universiti Putra Malaysia
name: Ateneo de Manila University
name: University of Cape Town
name: The LEGO Foundation
First posted: 2021-08-12
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A factorial design will be used testing the four components, with a total of 16 conditions. The purpose of this factorial experiment is to estimate the main effects of the four intervention components and interactions between the components, not to compare the 16 experimental conditions to each other.
Primary purpose: PREVENTION

Brief summary: The study has two main aims. The first aim is to optimise user engagement in ParentText. The goal is to identify the optimal delivery of ParentText for parents/caregivers from low- and middle-income countries, using a randomised between-subjects factorial experimental design.

The second aim is to examine the preliminary effectiveness of the chatbot adaption of the Parenting for Lifelong Health programme, ParentText, on the primary outcome of child maltreatment and secondary outcomes of positive parenting, parental self-efficacy, parental communication about sexual abuse, financial stress, parental stress, child behaviour problems, and intimate partner violence.

This study is part of a multi-phase research project. The full research project has been registered to the Open Science Framework platform.

To address the first aim, the investigators will be conducting a factorial experiment which will examine the impact of four components, Personalisation (High/Low), Gamification (On/Off), Gender Targeting (On/Off), Frequency of message (1 per day/ 3 per day) on participant engagement. The factorial experiment will be conducted in two countries, Malaysia and South Africa. Within each country, the investigators have local partners who will be involved in deploying the intervention and recruiting participants. Parents/caregivers will be primarily recruited through country-specific UNICEF U-Report platforms and government partners. RapidPro, the programme on which the chatbot is deployed, will randomly allocate participants to the 16 experimental conditions. The purpose of the factorial experiment is to estimate the main and interaction effects of the four components. Based on the results the investigators will optimise the delivery of ParentText by selecting components or components levels that promote the highest level of engagement based on effect size.

The second aim will be addressed by conducting latent growth curve models or multi-level models, to examine the changes in outcome variables over time. The experiment will be conducted across five countries, Malaysia, South Africa, the Philippines, Jamaica and Sri Lanka. Within each country, the investigators have local partners who will be involved in deploying the intervention and recruiting participants.

Detailed description: Research has shown that the modification of parenting programmes from being held in-person to being delivered digitally has been successful. Meta-analytic and systematic reviews carried out in HMICs have illustrated that digital parenting interventions have similar effect sizes to in-person interventions. Although these results are promising, there are few gaps within the literature that have not been addressed. First, the majority of research is being conducted in High-Income Countries (HICs). Therefore, results cannot be generalised to LMICs, where differences in context and culture could have an impact on the effectiveness of digital parenting interventions. Second, parenting interventions are deployed on a variety of different technological platforms, however, a limited amount of research has focused on examining emerging platforms, with the focus primarily being on app or internet-based interventions. Therefore little is known in regards to the effectiveness of more novel intervention platforms, such as chatbots.

Whilst the digitalisation of parenting programmes allows for the widespread dissemination and utilisation of the intervention, engagement rates for digital interventions remain low. Engagement with digital behaviour change interventions can be described as the extent (e.g. amount, frequency, duration, depth) of usage, and as a subjective experience characterised by attention, interest and affect. Low engagement compromises the effectiveness of parenting programmes, as the user is required to enrol and engage with the intervention for the programme to have an influence on behaviour. Intervention developers have begun employing technological platforms, such as chatbots, that are designed with the intention to overcome low user engagement rates.

Parenting research investigating digital intervention components which facilitate engagement remains scarce. Broadening the scope beyond the field of parenting, reviews of quantitative and qualitative research examining digital behaviour change interventions, identified an assortment of behaviour change techniques and persuasive system design principles which have been found to facilitate and impede engagement and effectiveness. However, few consistent patterns emerged regarding what techniques and principles consistently facilitate engagement and effectiveness, and for whom. There is a requirement for the isolated techniques and principles utilised within digital parenting interventions to be tested, to identify which intervention components influence engagement and intervention effectiveness and apply this research to optimise parenting interventions.

The first aim of this study is to optimise user engagement in ParentText and to identify the optimal delivery of ParentText for parents/caregivers from low- and middle-income countries. The investigators will be addressing three research questions:

1. How do different component levels impact ParentText user engagement and retention in terms of a) message personalisation (high/low), b) gendered targeted messages (on/off), c) gamification of module completions (on/off) and d) frequency of messages (high/low)?
2. Are there any interaction effects between different component levels of ParentText on user engagement and retention?
3. How does the effectiveness of each component or component level on user engagement vary by different population characteristics (i.e., parent/child age and gender, parent/caregiver marital status, parent/caregiver relationship to the child, and experience of COVID-19)?

The factorial experiment will be conducted across two countries, Malaysia and South Africa. Within each country, the investigators have local partners who will be involved in deploying the intervention and recruiting participants who take care of a child aged between 0 and 17 years old. Parents/caregivers will be primarily recruited through country-specific UNICEF U-Report platforms and government partners.

The following components have been selected, based on research that concluded that these components have been efficient in increasing engagement with digital interventions.

Component A: Personalisation (High/Low): Half of the participants will receive high levels of personalisation, receiving messages that utilise their (nick)name and the child's (nick)name. Half of the participants will not receive this type of personalisation.

Component B: Gendered Targeted Messages (On/Off): Half of the participants will receive messages that are tailored towards either being a female or male caregiver. The other half will not.

Component C: Gamification of Module Completion (On/Off): Half of the participants will receive a gamified progress update on what modules that they have completed. This will be represented as the House of Support. As the parent completes parenting skills, the layers of the house will fill in, representing their progress. The other half of the participants will not be receiving gamified progress updates.

Component D: Frequency of Messages (High/Low). Half of the participants will receive 3 interactions a day (high intensity), the other half will receive 1 interaction a day (low intensity).

The current factorial experimental trial will randomise participants into the 16 experimental conditions. Although this experiment has 16 experimental conditions, it is not a 16-arm RCT. The purpose of this factorial experiment is to estimate the main and intervention effects between the components and not to compare them to one another.

The study will examine the following hypotheses:

Hypotheses

* Participants who receive high levels of personalisation will show higher levels of engagement in ParentText, than compared to users receiving low levels of personalisation.
* Participants who receive gender-targeted messages will show higher levels of engagement in ParentText, than compared to users receiving no gender-targeted messages.
* Participants who receive gamified progress updates will show higher levels of engagement in ParentText, than compared to users receiving non-gamified progress updates.

Exploratory Hypotheses

* The investigators will explore how the frequency of messages will impact engagement.
* The investigators will explore how the effectiveness of components on engagement will vary dependent on demographic characteristics.
* The investigators will explore interaction effects between experimental components.

The second aim of the study is to examine the preliminary effectiveness of the chatbot adaption of the Parenting for Lifelong Health programme, ParentText on the primary outcome of child maltreatment and the secondary outcomes of positive parenting, parental self-efficacy, parental communication about sexual abuse, financial stress, parental stress, child behaviour problems, IPV, attitudes toward gender roles and IPV, and gender-equitable behaviours. The investigators will be investigating five research questions:

1. How does overall child maltreatment (primary outcome) change over time for parents/caregivers engaged in the ParentText intervention?
2. How do the following secondary outcomes change over time for parents/caregivers engaged in the ParentText intervention: physical abuse, emotional abuse, positive parenting, parental self-efficacy, parental communication about sexual abuse, financial stress, parental stress, child behaviour problems, intimate partner violence (IPV) victimisation and perpetration, attitudes toward intimate partner violence (IPV) and gender roles, and gender-equitable behaviours?
3. How do changes in secondary outcomes mediate change in overall child maltreatment?
4. How do changes in primary and secondary outcomes vary based on different population characteristics (i.e., parent/child age and gender, parent/caregiver marital status, parent/caregiver relationship to the child, and experience of COVID-19)?
5. What is the association between user engagement and change over time in primary outcomes and secondary outcomes?

Exploratory Hypotheses

* ParentText will have a significant impact on our primary outcome, decreasing child maltreatment.
* ParentText will have a significant impact on our secondary outcomes, increasing positive parenting, parental self-efficacy, parental communication about sexual abuse, gender-equitable behaviours and improving attitudes toward gender roles and IPV, as well as reducing financial stress, parental stress, child behaviour problems, intimate partner violence (IPV) victimisation and perpetration.
* The investigators will explore how the impact of ParentText will vary depending on user engagement and demographic characteristics.
* The investigators will also explore interaction effects between experimental components.

The experiment will be conducted in five countries, Malaysia, South Africa, Jamaica, the Philippines and Sri Lanka. Country specific recruitment is outlined below:

South Africa: Investigators will collaborate with Clowns Without Borders South Africa and the Department of Social Development to deploy and recruit participants in the Northern Cape. Participants will be recruited by radio announcements. The investigators are also collaborating with UNICEF South Africa who will assist in recruiting participants over the age of 20 via their U-Report Platform (N = 79,800). UNICEF South Africa will send U-reporters an unsolicited recruitment message that is accompanied by a link that takes users to the landing site of ParentText.

Malaysia: 20-35 participants will be recruited by our implementing partner, Generasi Gemilang from their family programmes. Participants will also be recruited either by UNICEF via their U-Report Platform (N = 25,200) or through the National Population and Family Development Board (LPPKN), which will blast messages to individuals who have previously participated in the LPPNK parenting workshops (N = 20,000).

Jamaica: Participants will be recruited in collaboration with UNICEF Jamaica and Parenting Partners Caribbean as part of the Spotlight Initiative, a community-wide intervention aimed at reducing violence against women and girls. Participants will be recruited in four parishes (N = 1,000). Parents and caregivers from the Spotlight initiative will be recruited by community youth activists, leaflets, radio announcements, posters, and other community-wide activities.

The Philippines: Participants will be recruited in collaboration with the Philippine Department of Social Welfare and Development. 30 families will be targeted who are enrolled in a conditional cash transfer programme (4Ps) who live in the Valenzuela municipality of Metro Manila.

Sri Lanka: Participants will be recruited in collaboration with the Health Promotion Bureau. Over 492,640 people follow this channel. The population includes media personal, health care service providers, community leaders, employers at all levels of industry and their organisations: hotels, supermarkets, banks, Ceylon Employer's Federation and the general public who uses Viber social media in Sri Lanka. The Health Promotion Bureau will select randomly individuals who are over 18 to receive a recruitment message to ParentText.

Eligibility criteria: Inclusion criteria for the participating parents/caregivers: over 18 years old, currently caring for a child between the ages of 0 to 17 years, access to a phone which can either receive SMS or has access to internet, and has provided consent to participate in the study.

Primary outcomes:
measure: Overall response to ParentText messages
timeFrame: Through study completion, an average of 16 weeks
measure: Overall completion rate of ParentText Content
timeFrame: Through study completion, an average of 16 weeks
measure: Change over time in Child Maltreatment
timeFrame: Through study completion, an average of 16 weeks
Secondary outcomes:
measure: Rate of response to tip offers
timeFrame: Through study completion, an average of 16 weeks
measure: Rate of response to calm messages
timeFrame: Through study completion, an average of 16 weeks
measure: Rate of response to praise messages
timeFrame: Through study completion, an average of 16 weeks
measure: Rate of response to supportive messages
timeFrame: Through study completion, an average of 16 weeks
measure: Rate of response to check in messages
timeFrame: Through study completion, an average of 16 weeks
measure: The number of messages the participant sent to the chatbot within a parenting skill.
timeFrame: Through study completion, an average of 16 weeks
measure: The completion rate of parenting tips
timeFrame: Through study completion, an average of 16 weeks
measure: The completion rate of self-led content
timeFrame: Through study completion, an average of 16 weeks
measure: The completion rate of survey assessments
timeFrame: Through study completion, an average of 16 weeks
measure: The completion rate of home practice
timeFrame: Through study completion, an average of 16 weeks
measure: Experience with the skill
timeFrame: Through study completion, an average of 16 weeks
measure: Consent to survey
timeFrame: Through study completion, an average of 16 weeks
measure: Response to survey questions
timeFrame: Through study completion, an average of 16 weeks
measure: Participant Active Dropout
timeFrame: Through study completion, an average of 16 weeks
measure: Participant Passive Dropout
timeFrame: Through study completion, an average of 16 weeks
measure: Change over time in Physical Abuse
timeFrame: Through study completion, an average of 16 weeks
measure: Change over time in Emotional Abuse
timeFrame: Through study completion, an average of 16 weeks
measure: Change over time in Positive Parenting
timeFrame: Through study completion, an average of 16 weeks
measure: Change over time in Parenting Stress
timeFrame: Through study completion, an average of 16 weeks
measure: Change over time in Financial Stress
timeFrame: Through study completion, an average of 16 weeks
measure: Change over time in Parental Self-efficacy
timeFrame: Through study completion, an average of 16 weeks
measure: Change over time in Parental Communication about Sexual Abuse Prevention
timeFrame: Through study completion, an average of 16 weeks
measure: Change over time in Child Behaviour Problems
timeFrame: Through study completion, an average of 16 weeks
measure: Change over time in Female IPV Victimisation
timeFrame: Through study completion, an average of 16 weeks and 1 and 3 months follow up
measure: Change over time in Male IPV Perpetration
timeFrame: Through study completion, an average of 16 weeks and 1 and 3 months follow up
measure: Change over time in Attitudes towards gender roles and IPV
timeFrame: Through study completion, an average of 16 weeks and 1 and 3 months follow up
measure: Gender equitable behaviours
timeFrame: Through study completion, an average of 16 weeks and 1 and 3 months follow up
Other outcomes:
measure: Demographics
timeFrame: Through study completion, an average of 16 weeks
measure: Impact of COVID-19
timeFrame: Through study completion, an average of 16 weeks
measure: Helpfulness of tips
timeFrame: Through study completion, an average of 16 weeks
measure: Acceptability of the Programme
timeFrame: Through study completion, an average of 16 weeks
Locations:
city: Putrajaya
country: Malaysia
facility: Family and Child Ecology at the Department of Human Development and Family Studies
state: Putraja
Study officials:
affiliation: Universiti Putra Malaysia
name: Rumaya Binti Juhari, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Ateneo de Manila University
name: Liane Peña Alampay, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Ateneo de Manila University
name: Rosanne Jocson, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cape Town
name: Hlengiwe Sacolo, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oxford
name: Frances Gardner, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanzania National Institute of Medical Research)
name: Joyce Wamoyi, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: UNICEF Jamaica
name: Ytske Van Winden
role: PRINCIPAL_INVESTIGATOR
affiliation: IDEMS International
name: David Stern, Dr
role: PRINCIPAL_INVESTIGATOR
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