ParentText User Engagement and Effectiveness Study

Intimate Partner Violence Clinical Trial

Official title:

ParentText User Engagement and Effectiveness Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05003518
• Other study ID #: ParentTextOpti
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: April 2024
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1400
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child Maltreatment
• Intimate Partner Violence
• Positive Parenting

Intervention

Behavioral:
• ParentText
ParentText delivers content, aligning with children's developmental stages (0-23 months, 2-9 years, 10-17 years). ParentText content is delivered through text messages, images, audio and video for parents/ caregivers and their children. Parents receive parenting content surrounding three themes: 1) relationship building by spending time together, 2) positive reinforcement, 3) stress reduction for parents and caregivers. Further supportive content is available for parents of children living with disabilities, child development, online child safety, talking about COVID-19 with children, family budgeting, family harmony, helping with schoolwork and sexual violence prevention.

Locations

Country	Name	City	State
Malaysia	Family and Child Ecology at the Department of Human Development and Family Studies	Putrajaya	Putraja

Sponsors (12)

Lead Sponsor	Collaborator
University of Oxford	Ateneo de Manila University, Health Promotion Bureau, Sri Lanka, IDEMS International, The LEGO Foundation, UNICEF Jamaica, UNICEF Malaysia, UNICEF Philippines, UNICEF South Africa, UNICEF Sri Lanka, Universiti Putra Malaysia, University of Cape Town

Country where clinical trial is conducted

Malaysia, 

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* Note: There are 69 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographics	The parent/caregiver will be asked for their name, gender, and relationship status, country, state, as well as their relationship to the child, the child's name, gender, and age-group and age. They will also be asked if they are a parent/caregiver of a child living with disabilities.	Through study completion, an average of 16 weeks
Other	Impact of COVID-19	Participants will be asked, how has COVID-19 affected their family? The participant will be asked to indicate one of the 6 options (someone in my family has had COVID-19 symptoms, someone in my family has died of COVID-19, my family has been experiencing financial stress due to COVID-19, family has been experiencing emotional stress due to COVID-19, my family has not been negatively affected by COVID-19, my family has not been affected by COVID-19). Participants will also be asked whether their children currently go to school/day-care?	Through study completion, an average of 16 weeks
Other	Helpfulness of tips	Participants will be asked, whether the advice was helpful? (Not helpful; A little helpful; helpful; very helpful; extremely helpful; prefer not to say). Participants will be asked whether the programme was helpful in improving their relationship with their child. Participants will also be asked which parenting tip they found the most useful.	Through study completion, an average of 16 weeks
Other	Acceptability of the Programme	Participants will be asked questions in regards to their experience with the programme. First participants will be asked to "tell us about the length of the ParentText programme (total number of days you received messages). ParentText was.. . 1)Too short, 2) Just right, 3) Too long. The second question asks participants "tell us about the number of messages that you received each day. They were... 1) Too few, 2) Just right, 3) Too many. Lastly, participants will also be asked an open-ended question, "Is there anything we can do to improve the ParentText chatbot for other families?".	Through study completion, an average of 16 weeks
Primary	Overall response to ParentText messages	Number of many messages the participants responded to or timed out from the intervention (no engagement for 2 hours or more). This is a measure of engagement with the chatbot.	Through study completion, an average of 16 weeks
Primary	Overall completion rate of ParentText Content	Number of the overall content the participant completed. This is a measure of completion of the programme.	Through study completion, an average of 16 weeks
Primary	Change over time in Child Maltreatment	Child maltreatment will be a composite measure utilising two items adapted from the reduced version of the ISPCAN Child Abuse Screening Tool-Trial Parent Version (ICAST-TP) (Meinck et al., 2018), which is adapted from the survey instrument ICAST-Parent Version (ICAST-P) (Runyan et al., 2009). The ICAST-P was developed to be deployed multi-nationally and multi-culturally and has been successfully utilised in LMICs (Nøkleby et al., 2019). The ICAST-TP measures parental reports of incidences of abuse perpetrated against their child over the past week and asks parents/caregivers to answer a frequency score on a scale of 0 to 7 times. One item will assess physical abuse, "How many days in the past week did you physically discipline your children by hitting, spanking, or slapping with your hand or an object like a stick or a belt?". The other item will assess emotional abuse, "How many days in the past week did you shout, scream, or yell at your children?".	Through study completion, an average of 16 weeks
Secondary	Rate of response to tip offers	This is a measure of engagement with the chatbot parenting content messages.	Through study completion, an average of 16 weeks
Secondary	Rate of response to calm messages	This is a measure of engagement with the chatbot stress-reduction messages.	Through study completion, an average of 16 weeks
Secondary	Rate of response to praise messages	This is a measure of engagement with the chatbot positive reinforcement messages.	Through study completion, an average of 16 weeks
Secondary	Rate of response to supportive messages	This is a measure of engagement with the chatbot supportive messages.	Through study completion, an average of 16 weeks
Secondary	Rate of response to check in messages	This is a measure of engagement with the chatbot check-in messages.	Through study completion, an average of 16 weeks
Secondary	The number of messages the participant sent to the chatbot within a parenting skill.	This is a measure of engagement with the programme.	Through study completion, an average of 16 weeks
Secondary	The completion rate of parenting tips	This is a measure of completion of the parenting modules during the programme.	Through study completion, an average of 16 weeks
Secondary	The completion rate of self-led content	This is a measure of completion of on-demand content during the programme.	Through study completion, an average of 16 weeks
Secondary	The completion rate of survey assessments	This is a measure of completion of assessment tools.	Through study completion, an average of 16 weeks
Secondary	The completion rate of home practice	This is a measure of engagement with applying parenting skills learned through the chatbot.	Through study completion, an average of 16 weeks
Secondary	Experience with the skill	This is a measure of the participants experience with engaging with the skill.	Through study completion, an average of 16 weeks
Secondary	Consent to survey	Participants can respond yes, no, or timeout to giving consent to the survey. This is a measure of engagement with the survey.	Through study completion, an average of 16 weeks
Secondary	Response to survey questions	Participants can respond, skip, or timeout to survey questions. This is a measure of engagement with the survey.	Through study completion, an average of 16 weeks
Secondary	Participant Active Dropout	Participants that actively exit the intervention.	Through study completion, an average of 16 weeks
Secondary	Participant Passive Dropout	Participants who timeout of the intervention and do not reengage with the intervention after one week.	Through study completion, an average of 16 weeks
Secondary	Change over time in Physical Abuse	Physical abuse will be assessed using one item adapted from the reduced version of the ISPCAN Child Abuse Screening Tool-Trial Parent Version (ICAST-TP) (Meinck et al., 2018). The item will assess physical abuse by asking, "How many days in the past week did you physically discipline your children by hitting, spanking, or slapping with your hand or an object like a stick or a belt?"	Through study completion, an average of 16 weeks
Secondary	Change over time in Emotional Abuse	Emotional abuse will be assessed using an item adapted from the reduced version of the ISPCAN Child Abuse Screening Tool-Trial Parent Version (ICAST-TP) (Meinck et al., 2018). The item will assess emotional abuse by asking parents/caregivers, "How many days in the past week did you shout, scream, or yell at your children?"	Through study completion, an average of 16 weeks
Secondary	Change over time in Positive Parenting	Positive parenting will be assessed two items from the Alabama Parenting Questionnaire (APQ) (Frick, 1991). The items included are "How many days in the past week did you and your child do something fun together?" and "How many days in the past week did you praise your child for doing well?" The parent/caregiver will be asked to give a frequency score, on a scale of 0 to 7 times.	Through study completion, an average of 16 weeks
Secondary	Change over time in Parenting Stress	Parenting stress will be assessed using one item adapted from the Parenting Stress Scale (PSS) (Berry & Jones, 1995). The item asks, "How many days in the past week did you feel very stressed as a parent/caregiver?" The items will be rated on a frequency scale of 0 to 7 times.	Through study completion, an average of 16 weeks
Secondary	Change over time in Financial Stress	Financial stress will be assessed using two items adapted from the Financial Self-Efficacy Scale (FSES) (Lown, 2011). The first items asks, "How many days in the past week have you felt very worried or anxious about money?" The parent/caregiver will be asked to give a frequency score, on a scale of 0 to 7 times. The second item asks, "How many days in the past month (30 days) did you run out of money to pay for food?" The parent/caregiver will be asked to indicate the number of days by typing a number between 0 and 30.	Through study completion, an average of 16 weeks
Secondary	Change over time in Parental Self-efficacy	Parental self-efficacy will be assessed using one item was adapted from the Parenting Sense of Competence Scale (Ohan et al., 2000). The item asks, "How confident do you feel about your ability as a parent/caregiver to have a positive relationship with your children? Parents/caregivers will respond based on an 8-point Likert scale of ranging from 0 (not confident) to 7 (extremely confident).	Through study completion, an average of 16 weeks
Secondary	Change over time in Parental Communication about Sexual Abuse Prevention	Parental Communication about Sexual Abuse Prevention will be assessed using two items adapted from the Parent Teen Sexual Risk Communication Scale III (PTSRC-III) (Hutchinson, 2007). One item asks, "In the past month, have you talked with your teen about keeping them safe from sexual violence in the community or online?" Parents/caregivers can respond yes or no. If they respond yes, they will be asked, "How many days have you had a talk like this?". The parent/caregiver will be asked to indicate the number of days by typing a number between 0 and 30.	Through study completion, an average of 16 weeks
Secondary	Change over time in Child Behaviour Problems	Child behaviour problems will be assessed using an adapted version of the Parent Daily Report (PDR) (Chamberlain & Reid, 1987). Parents/Caregivers are presented with a list of ten typical behaviours that can be challenging for parents that are relevant to their child's age groups. Parents/caregivers are asked to select the behaviour which describes the most challenging behaviours. Parents/caregivers are asked to indicate how challenging the chosen behaviour is on a scale of 0 to 7 (0 = not a problem, 7= terrible).	Through study completion, an average of 16 weeks
Secondary	Change over time in Female IPV Victimisation	Female IPV victimisation will be measured using items on physical violence (1 item), psychological abuse (1 item), sexual abuse (1 item), coercion (1 item), and economic abuse (1 item). Female IPV perpetration will be assessed using two items adapted from the VAWI (García-Moreno et al., 2005), which ask: "During any potential times that you were hit in the past month, did you ever fight back physically to defend yourself?" and "In the past month, have you ever hit or physically mistreated your partner when they were not hitting or physically mistreating you?". The female IPV assessment at baseline will also include one item that asks participants about any experiences of IPV victimisation they may have had in the past 12 months. Parents/caregivers are asked to give a frequency score on a scale of 0 to +8 times.	Through study completion, an average of 16 weeks and 1 and 3 months follow up
Secondary	Change over time in Male IPV Perpetration	Male IPV perpetration will be measured using items on physical violence (1 item), psychological abuse (1 item), sexual abuse (1 item), coercion (1 item), and economic abuse (1 item). Male IPV victimisation will be assessed using two items adapted from the VAWI: "In the past month, during any potential times that you may have used violence against your partner, did they ever fight back physically to defend themselves?" and "In the past month, have you ever been hit or physically mistreated by your partner when you were not hitting or physically mistreating them?". The male IPV assessment at baseline will also include one item that asks participants about any their experiences of IPV perpetration in the past 12 months. Parents/caregivers are asked to give a frequency score on a scale of 0 to +8 times.	Through study completion, an average of 16 weeks and 1 and 3 months follow up
Secondary	Change over time in Attitudes towards gender roles and IPV	Attitudes towards gender roles and IPV will be measured by self-report using six items included in the 'Attitudes toward gender roles' section of the WHO Multi-Country Study on Domestic Violence (García-Moreno et al., 2005). These items include statements such as "A woman should obey her husband's wishes even if she disagrees". . Parents/caregivers are asked to indicate whether they agree or disagree with the statements provided based on a Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree).	Through study completion, an average of 16 weeks and 1 and 3 months follow up
Secondary	Gender equitable behaviours	Gender equitable behaviours will be measured using four items adapted from a questionnaire developed by researchers at the London School of Hygiene and Tropical Medicine which was used in an RCT of a violence prevention intervention in Tanzania (Kapiga et al., 2019). These items include questions on couple communication, joint decision-making, shared housework and caregiving, and partner conflict resolution, with questions such as: 'In the past week, how many times did you and your partner talk about your worries and feelings?" and "In the past week, how many times did you and your partner make a decision together?". Parents/caregivers are asked to report on whether in the past week the specific behaviour occurred on a scale of 0 (never) to 3 (many times).	Through study completion, an average of 16 weeks and 1 and 3 months follow up