EngagementNCT05003518
ParentText User Engagement and Effectiveness Study
A study testing ParentText in people with Engagement and Positive Parenting, run by University of Oxford at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Engagement, Positive Parenting, Child Maltreatment
- What is being tested?
- ParentText
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jun 2022to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Family and Child Ecology at the Department of Human Development and Family Studies
Putrajaya, Putraja
About this study
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.
Read more
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.
Read the 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:
- 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)?
- Are there any interaction effects between different component levels of ParentText on user engagement and retention?
- 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:
- How does overall child maltreatment (primary outcome) change over time for parents/caregivers engaged in the ParentText intervention?
- 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?
- How do changes in secondary outcomes mediate change in overall child maltreatment?
- 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)?
- 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.
- Being tested
- ParentText
- Keywords
- Engagement, Chatbot, Digital Behaviour Change Intervention, Parenting Intervention, Optimisation, Positive Parenting, Child Maltreatment, Intimate Partner Violence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParentTextBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Condition 1: Low Personalisation+Low Frequency | Experimental | The intervention will have low levels of personalisation and one message a day will be sent to participants. Receives: Behavioral: ParentText |
| Condition 2: High Personalisation+Low Frequency | Experimental | The intervention will have high levels of personalisation (utilise the user's nickname and their child's nickname) and one message a day will be sent to participants. Receives: Behavioral: ParentText |
| Condition 3: Low Personalisation+High Frequency | Experimental | The intervention will have low levels of personalisation and three messages a day will be sent to participants. Receives: Behavioral: ParentText |
| Condition 4: High Personalisation+High Frequency | Experimental | The intervention will have high levels of personalisation and three messages a day will be sent to participants. Receives: Behavioral: ParentText |
| Condition 5: High Personalisation+Low Frequency+Gamification | Experimental | The intervention will have high levels of personalisation (utilise the user's nickname and their child's nickname), contains gamified progress updates, and one message a day will be sent to participants. Receives: Behavioral: ParentText |
| Condition 6: Low Personalisation+High Frequency+Gamification | Experimental | The intervention will have low levels of personalisation, contains gamified progress updates, and three messages a day will be sent to participants. Receives: Behavioral: ParentText |
| Condition 7: High Personalisation+High Frequency+Gamification | Experimental | The intervention will have high levels of personalisation (utilise the user's nickname and their child's nickname), contains gamified progress updates, and three message a day will be sent to participants. Receives: Behavioral: ParentText |
| Condition 8: Low Personalisation+Low Frequency+Gender Targeting | Experimental | The intervention will have low levels of personalisation, contains gender targeted messages, and one message a day will be sent to participants. Receives: Behavioral: ParentText |
| Condition 9: High Personalisation+Low Frequency+Gender Targeting | Experimental | The intervention will have high levels of personalisation (utilise the user's nickname and their child's nickname), contains gender targeted messages, and one message a day will be sent to participants. Receives: Behavioral: ParentText |
| Condition 10: Low Personalisation + High Frequency + Gender Targeting | Experimental | The intervention will have low levels of personalisation, contains gender targeted messages, and three message a day will be sent to participants. Receives: Behavioral: ParentText |
| Condition 11: High Personalisation + High Frequency + Gender Targeting | Experimental | The intervention will have high levels of personalisation (utilise the user's nickname and their child's nickname), contains gender targeted messages, and three message a day will be sent to participants. Receives: Behavioral: ParentText |
| Condition 12: Low Personalisation + Low Frequency + Gamification + Gender Targeting | Experimental | The intervention will have low levels of personalisation, contains gender targeted messages and gamified progress updates. Participants will be sent one message a day. Receives: Behavioral: ParentText |
| Condition 13: High Personalisation + Low Frequency + Gamification + Gender Targeting | Experimental | The intervention will have high levels of personalisation (utilise the user's nickname and their child's nickname), contains gender targeted messages and gamified progress updates. Participants will be sent one message a day. Receives: Behavioral: ParentText |
| Condition 14: Low Personalisation + High Frequency + Gamification + Gender Targeting | Experimental | The intervention will have low levels of personalisation (utilise the user's nickname and their child's nickname), contains gender targeted messages and gamified progress updates. Participants will be sent three message a day. Receives: Behavioral: ParentText |
| Condition 15: High Personalisation + High Frequency + Gamification + Gender Targeting | Experimental | The intervention will have high levels of personalisation (utilise the user's nickname and their child's nickname), contains gender targeted messages and gamified progress updates. Participants will be sent three messages a day. Receives: Behavioral: ParentText |
| Condition 16: Low Personalisation+Low Frequency+Gamification | Experimental | The intervention will have low levels of personalisation (utilise the user's nickname and their child's nickname), contains gamified progress updates, and one message a day will be sent to participants. Receives: Behavioral: ParentText |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 16 weeks
Overall completion rate of ParentText Content
Number of the overall content the participant completed. This is a measure of completion of the programme.
Measured: Through study completion, an average of 16 weeks
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?".
Measured: Through study completion, an average of 16 weeks
Secondary outcomes (27)
Rate of response to tip offers
This is a measure of engagement with the chatbot parenting content messages.
Measured: Through study completion, an average of 16 weeks
Rate of response to calm messages
This is a measure of engagement with the chatbot stress-reduction messages.
Measured: Through study completion, an average of 16 weeks
Rate of response to praise messages
This is a measure of engagement with the chatbot positive reinforcement messages.
Measured: Through study completion, an average of 16 weeks
Rate of response to supportive messages
This is a measure of engagement with the chatbot supportive messages.
Measured: Through study completion, an average of 16 weeks
Rate of response to check in messages
This is a measure of engagement with the chatbot check-in messages.
Measured: Through study completion, an average of 16 weeks
The number of messages the participant sent to the chatbot within a parenting skill.
This is a measure of engagement with the programme.
Measured: Through study completion, an average of 16 weeks
The completion rate of parenting tips
This is a measure of completion of the parenting modules during the programme.
Measured: Through study completion, an average of 16 weeks
The completion rate of self-led content
This is a measure of completion of on-demand content during the programme.
Measured: Through study completion, an average of 16 weeks
The completion rate of survey assessments
This is a measure of completion of assessment tools.
Measured: Through study completion, an average of 16 weeks
The completion rate of home practice
This is a measure of engagement with applying parenting skills learned through the chatbot.
Measured: Through study completion, an average of 16 weeks
Experience with the skill
This is a measure of the participants experience with engaging with the skill.
Measured: Through study completion, an average of 16 weeks
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.
Measured: Through study completion, an average of 16 weeks
Response to survey questions
Participants can respond, skip, or timeout to survey questions. This is a measure of engagement with the survey.
Measured: Through study completion, an average of 16 weeks
Participant Active Dropout
Participants that actively exit the intervention.
Measured: Through study completion, an average of 16 weeks
Participant Passive Dropout
Participants who timeout of the intervention and do not reengage with the intervention after one week.
Measured: Through study completion, an average of 16 weeks
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?"
Measured: Through study completion, an average of 16 weeks
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?"
Measured: Through study completion, an average of 16 weeks
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.
Measured: Through study completion, an average of 16 weeks
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.
Measured: Through study completion, an average of 16 weeks
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.
Measured: Through study completion, an average of 16 weeks
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).
Measured: Through study completion, an average of 16 weeks
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.
Measured: Through study completion, an average of 16 weeks
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).
Measured: Through study completion, an average of 16 weeks
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.
Measured: Through study completion, an average of 16 weeks and 1 and 3 months follow up
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.
Measured: Through study completion, an average of 16 weeks and 1 and 3 months follow up
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).
Measured: Through study completion, an average of 16 weeks and 1 and 3 months follow up
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).
Measured: Through study completion, an average of 16 weeks and 1 and 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start1 Jun 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Why it stopped: Insufficient participants were recruited for the optimisation trial. Study procedures revised to conduct a pilot of intervention acceptability, feasibility, and preliminary change in psychosocial behavioural outcomes.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (69)Papers the sponsor has linked to this study.
- Other trials for EngagementStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- IDEMS International, UNICEF South Africa, UNICEF Malaysia, UNICEF Sri Lanka, UNICEF Jamaica, UNICEF Philippines, Health Promotion Bureau, Sri Lanka, Universiti Putra Malaysia, Ateneo de Manila University, University of Cape Town, LEGO Foundation
- Responsible party
- Principal investigator, DrJamieLachman, University of Oxford
- Investigators
- Rumaya Binti Juhari, Dr, Principal investigator, Universiti Putra MalaysiaLiane Peña Alampay, Dr, Principal investigator, Ateneo de Manila UniversityRosanne Jocson, Dr, Principal investigator, Ateneo de Manila UniversityHlengiwe Sacolo, Dr, Principal investigator, University of Cape TownFrances Gardner, Dr, Principal investigator, University of OxfordJoyce Wamoyi, Dr, Principal investigator, Tanzania National Institute of Medical Research)Ytske Van Winden, Principal investigator, UNICEF JamaicaDavid Stern, Dr, Principal investigator, IDEMS International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003518
- Sponsor's protocol ID
- ParentTextOpti
- Status last verified
- Apr 2024
- First submitted
- 28 Jul 2021
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data will be shared on Open Science Framework after the completion of the study and once the results have been published.
Publications
Ariely, D., Bracha, A., & Meier, S. (2009). Doing Good or Doing Well? Image Motivation and Monetary Incentives in Behaving Prosocially. American Economic Review, 99(1), 544-555.
Asbjornsen RA, Smedsrod ML, Solberg Nes L, Wentzel J, Varsi C, Hjelmesaeth J, van Gemert-Pijnen JE. Persuasive System Design Principles and Behavior Change Techniques to Stimulate Motivation and Adherence in Electronic Health Interventions to Support Weight Loss Maintenance: Scoping Review. J Med Internet Res. 2019 Jun 21;21(6):e14265. doi: 10.2196/14265.
PubMed 31228174Axford, N., Lehtonen, M., Kaoukji, D., Tobin, K., & Berry, V. (2012). Engaging parents in parenting programs: Lessons from research and practice. Children and Youth Services Review, 34(10), 2061-2071.
Baker CN, Arnold DH, Meagher S. Enrollment and attendance in a parent training prevention program for conduct problems. Prev Sci. 2011 Jun;12(2):126-38. doi: 10.1007/s11121-010-0187-0.
PubMed 21052834Baumel A, Pawar A, Kane JM, Correll CU. Digital Parent Training for Children with Disruptive Behaviors: Systematic Review and Meta-Analysis of Randomized Trials. J Child Adolesc Psychopharmacol. 2016 Oct;26(8):740-749. doi: 10.1089/cap.2016.0048. Epub 2016 Jun 10.
PubMed 27286325Beatty L, Binnion C. A Systematic Review of Predictors of, and Reasons for, Adherence to Online Psychological Interventions. Int J Behav Med. 2016 Dec;23(6):776-794. doi: 10.1007/s12529-016-9556-9.
PubMed 26957109Berry, J. O., & Jones, W. H. (1995). The Parental Stress Scale - Initial Psychometric Evidence. Journal of Social and Personal Relationships, 12(3), 463-472.
Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative research in psychology, 3(2), 77-101.
Burns, G. L., Lee, S., Servera, M., McBurnett, K., & Becker, S. P. (2015). Child and Adolescent Behavior Inventory - Version 1.
Cacioppo, J. T., & Petty, R. E. (1989). Effects of message repetition on argument processing, recall, and persuasion. Basic and Applied Social Psychology, 10(1), 3-12.
Chamberlain, P., & Reid, J. B. (1987). Parent observation and report of child symptoms. Behavioral Assessment.
Cheong MWL, Allotey P, Reidpath DD. Unequal Access to Vaccines Will Exacerbate Other Inequalities. Asia Pac J Public Health. 2020 Sep-Oct;32(6-7):379-380. doi: 10.1177/1010539520944726. Epub 2020 Jul 25. No abstract available.
PubMed 32715721Collins LM, Murphy SA, Strecher V. The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions. Am J Prev Med. 2007 May;32(5 Suppl):S112-8. doi: 10.1016/j.amepre.2007.01.022.
PubMed 17466815Dadds MR, Sicouri G, Piotrowska PJ, Collins DAJ, Hawes DJ, Moul C, Lenroot RK, Frick PJ, Anderson V, Kimonis ER, Tully LA. Keeping Parents Involved: Predicting Attrition in a Self-Directed, Online Program for Childhood Conduct Problems. J Clin Child Adolesc Psychol. 2019 Nov-Dec;48(6):881-893. doi: 10.1080/15374416.2018.1485109. Epub 2018 Aug 1.
PubMed 30067388Daley K, Hungerbuehler I, Cavanagh K, Claro HG, Swinton PA, Kapps M. Preliminary Evaluation of the Engagement and Effectiveness of a Mental Health Chatbot. Front Digit Health. 2020 Nov 30;2:576361. doi: 10.3389/fdgth.2020.576361. eCollection 2020.
PubMed 34713049
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ParentText User Engagement and Effectiveness Study
- ClinicalTrials.gov ID
- NCT05003518
- Acronym / sponsor ID
- ParentTextOpti
- Keywords
- Engagement, Chatbot, Digital Behaviour Change Intervention, Parenting Intervention, Optimisation, Positive Parenting, Child Maltreatment, Intimate Partner Violence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient participants were recruited for the optimisation trial. Study procedures revised to conduct a pilot of intervention acceptability, feasibility, and preliminary change in psychosocial behavioural outcomes.
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- IDEMS International, UNICEF South Africa, UNICEF Malaysia, UNICEF Sri Lanka, UNICEF Jamaica, UNICEF Philippines, Health Promotion Bureau, Sri Lanka, Universiti Putra Malaysia, Ateneo de Manila University, University of Cape Town, LEGO Foundation
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)?
- Are there any interaction effects between different component levels of ParentText on user engagement and retention?
- 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:
- How does overall child maltreatment (primary outcome) change over time for parents/caregivers engaged in the ParentText intervention?
- 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?
- How do changes in secondary outcomes mediate change in overall child maltreatment?
- 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)?
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 16
- 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.
| Arm | Type | Receives |
|---|---|---|
| Condition 1: Low Personalisation+Low Frequency | Experimental | Behavioral: ParentTextThe intervention will have low levels of personalisation and one message a day will be sent to participants. |
| Condition 2: High Personalisation+Low Frequency | Experimental | Behavioral: ParentTextThe intervention will have high levels of personalisation (utilise the user's nickname and their child's nickname) and one message a day will be sent to participants. |
| Condition 3: Low Personalisation+High Frequency | Experimental | Behavioral: ParentTextThe intervention will have low levels of personalisation and three messages a day will be sent to participants. |
| Condition 4: High Personalisation+High Frequency | Experimental | Behavioral: ParentTextThe intervention will have high levels of personalisation and three messages a day will be sent to participants. |
| Condition 5: High Personalisation+Low Frequency+Gamification | Experimental | Behavioral: ParentTextThe intervention will have high levels of personalisation (utilise the user's nickname and their child's nickname), contains gamified progress updates, and one message a day will be sent to participants. |
| Condition 6: Low Personalisation+High Frequency+Gamification | Experimental | Behavioral: ParentTextThe intervention will have low levels of personalisation, contains gamified progress updates, and three messages a day will be sent to participants. |
| Condition 7: High Personalisation+High Frequency+Gamification | Experimental | Behavioral: ParentTextThe intervention will have high levels of personalisation (utilise the user's nickname and their child's nickname), contains gamified progress updates, and three message a day will be sent to participants. |
| Condition 8: Low Personalisation+Low Frequency+Gender Targeting | Experimental | Behavioral: ParentTextThe intervention will have low levels of personalisation, contains gender targeted messages, and one message a day will be sent to participants. |
| Condition 9: High Personalisation+Low Frequency+Gender Targeting | Experimental | Behavioral: ParentTextThe intervention will have high levels of personalisation (utilise the user's nickname and their child's nickname), contains gender targeted messages, and one message a day will be sent to participants. |
| Condition 10: Low Personalisation + High Frequency + Gender Targeting | Experimental | Behavioral: ParentTextThe intervention will have low levels of personalisation, contains gender targeted messages, and three message a day will be sent to participants. |
| Condition 11: High Personalisation + High Frequency + Gender Targeting | Experimental | Behavioral: ParentTextThe intervention will have high levels of personalisation (utilise the user's nickname and their child's nickname), contains gender targeted messages, and three message a day will be sent to participants. |
| Condition 12: Low Personalisation + Low Frequency + Gamification + Gender Targeting | Experimental | Behavioral: ParentTextThe intervention will have low levels of personalisation, contains gender targeted messages and gamified progress updates. Participants will be sent one message a day. |
| Condition 13: High Personalisation + Low Frequency + Gamification + Gender Targeting | Experimental | Behavioral: ParentTextThe intervention will have high levels of personalisation (utilise the user's nickname and their child's nickname), contains gender targeted messages and gamified progress updates. Participants will be sent one message a day. |
| Condition 14: Low Personalisation + High Frequency + Gamification + Gender Targeting | Experimental | Behavioral: ParentTextThe intervention will have low levels of personalisation (utilise the user's nickname and their child's nickname), contains gender targeted messages and gamified progress updates. Participants will be sent three message a day. |
| Condition 15: High Personalisation + High Frequency + Gamification + Gender Targeting | Experimental | Behavioral: ParentTextThe intervention will have high levels of personalisation (utilise the user's nickname and their child's nickname), contains gender targeted messages and gamified progress updates. Participants will be sent three messages a day. |
| Condition 16: Low Personalisation+Low Frequency+Gamification | Experimental | Behavioral: ParentTextThe intervention will have low levels of personalisation (utilise the user's nickname and their child's nickname), contains gamified progress updates, and one message a day will be sent to participants. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParentTextParentText 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. | Behavioural | Condition 10: Low Personalisation + High Frequency + Gender Targeting, Condition 11: High Personalisation + High Frequency + Gender Targeting, Condition 12: Low Personalisation + Low Frequency + Gamification + Gender Targeting, Condition 13: High Personalisation + Low Frequency + Gamification + Gender Targeting, Condition 14: Low Personalisation + High Frequency + Gamification + Gender Targeting, Condition 15: High Personalisation + High Frequency + Gamification + Gender Targeting, Condition 16: Low Personalisation+Low Frequency+Gamification, Condition 1: Low Personalisation+Low Frequency, Condition 2: High Personalisation+Low Frequency, Condition 3: Low Personalisation+High Frequency, Condition 4: High Personalisation+High Frequency, Condition 5: High Personalisation+Low Frequency+Gamification, Condition 6: Low Personalisation+High Frequency+Gamification, Condition 7: High Personalisation+High Frequency+Gamification, Condition 8: Low Personalisation+Low Frequency+Gender Targeting, Condition 9: High Personalisation+Low Frequency+Gender Targeting |
Primary outcome
Overall response to ParentText messages
Time frame: Through study completion, an average of 16 weeks
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.
Overall completion rate of ParentText Content
Time frame: Through study completion, an average of 16 weeks
Number of the overall content the participant completed. This is a measure of completion of the programme.
Change over time in Child Maltreatment
Time frame: Through study completion, an average of 16 weeks
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?".
27 secondary outcomes
Rate of response to tip offers
Time frame: Through study completion, an average of 16 weeks
Rate of response to calm messages
Time frame: Through study completion, an average of 16 weeks
Rate of response to praise messages
Time frame: Through study completion, an average of 16 weeks
Rate of response to supportive messages
Time frame: Through study completion, an average of 16 weeks
Rate of response to check in messages
Time frame: Through study completion, an average of 16 weeks
The number of messages the participant sent to the chatbot within a parenting skill.
Time frame: Through study completion, an average of 16 weeks
The completion rate of parenting tips
Time frame: Through study completion, an average of 16 weeks
The completion rate of self-led content
Time frame: Through study completion, an average of 16 weeks
The completion rate of survey assessments
Time frame: Through study completion, an average of 16 weeks
The completion rate of home practice
Time frame: Through study completion, an average of 16 weeks
Experience with the skill
Time frame: Through study completion, an average of 16 weeks
Consent to survey
Time frame: Through study completion, an average of 16 weeks
Response to survey questions
Time frame: Through study completion, an average of 16 weeks
Participant Active Dropout
Time frame: Through study completion, an average of 16 weeks
Participant Passive Dropout
Time frame: Through study completion, an average of 16 weeks
Change over time in Physical Abuse
Time frame: Through study completion, an average of 16 weeks
Change over time in Emotional Abuse
Time frame: Through study completion, an average of 16 weeks
Change over time in Positive Parenting
Time frame: Through study completion, an average of 16 weeks
Change over time in Parenting Stress
Time frame: Through study completion, an average of 16 weeks
Change over time in Financial Stress
Time frame: Through study completion, an average of 16 weeks
Change over time in Parental Self-efficacy
Time frame: Through study completion, an average of 16 weeks
Change over time in Parental Communication about Sexual Abuse Prevention
Time frame: Through study completion, an average of 16 weeks
Change over time in Child Behaviour Problems
Time frame: Through study completion, an average of 16 weeks
Change over time in Female IPV Victimisation
Time frame: Through study completion, an average of 16 weeks and 1 and 3 months follow up
Change over time in Male IPV Perpetration
Time frame: Through study completion, an average of 16 weeks and 1 and 3 months follow up
Change over time in Attitudes towards gender roles and IPV
Time frame: Through study completion, an average of 16 weeks and 1 and 3 months follow up
Gender equitable behaviours
Time frame: Through study completion, an average of 16 weeks and 1 and 3 months follow up
Results and safety
The study was stopped early (reason given: Insufficient participants were recruited for the optimisation trial. Study procedures revised to conduct a pilot of intervention acceptability, feasibility, and preliminary change in psychosocial behavioural outcomes.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- BackgroundAriely, D., Bracha, A., & Meier, S. (2009). Doing Good or Doing Well? Image Motivation and Monetary Incentives in Behaving Prosocially. American Economic Review, 99(1), 544-555.
- Background: PubMed 31228174Asbjornsen RA, Smedsrod ML, Solberg Nes L, Wentzel J, Varsi C, Hjelmesaeth J, van Gemert-Pijnen JE. Persuasive System Design Principles and Behavior Change Techniques to Stimulate Motivation and Adherence in Electronic Health Interventions to Support Weight Loss Maintenance: Scoping Review. J Med Internet Res. 2019 Jun 21;21(6):e14265. doi: 10.2196/14265.
- BackgroundAxford, N., Lehtonen, M., Kaoukji, D., Tobin, K., & Berry, V. (2012). Engaging parents in parenting programs: Lessons from research and practice. Children and Youth Services Review, 34(10), 2061-2071.
- Background: PubMed 21052834Baker CN, Arnold DH, Meagher S. Enrollment and attendance in a parent training prevention program for conduct problems. Prev Sci. 2011 Jun;12(2):126-38. doi: 10.1007/s11121-010-0187-0.
- Background: PubMed 27286325Baumel A, Pawar A, Kane JM, Correll CU. Digital Parent Training for Children with Disruptive Behaviors: Systematic Review and Meta-Analysis of Randomized Trials. J Child Adolesc Psychopharmacol. 2016 Oct;26(8):740-749. doi: 10.1089/cap.2016.0048. Epub 2016 Jun 10.
- Background: PubMed 26957109Beatty L, Binnion C. A Systematic Review of Predictors of, and Reasons for, Adherence to Online Psychological Interventions. Int J Behav Med. 2016 Dec;23(6):776-794. doi: 10.1007/s12529-016-9556-9.
- BackgroundBerry, J. O., & Jones, W. H. (1995). The Parental Stress Scale - Initial Psychometric Evidence. Journal of Social and Personal Relationships, 12(3), 463-472.
- BackgroundBraun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative research in psychology, 3(2), 77-101.
- BackgroundBurns, G. L., Lee, S., Servera, M., McBurnett, K., & Becker, S. P. (2015). Child and Adolescent Behavior Inventory - Version 1.
- BackgroundCacioppo, J. T., & Petty, R. E. (1989). Effects of message repetition on argument processing, recall, and persuasion. Basic and Applied Social Psychology, 10(1), 3-12.
- BackgroundChamberlain, P., & Reid, J. B. (1987). Parent observation and report of child symptoms. Behavioral Assessment.
- Background: PubMed 32715721Cheong MWL, Allotey P, Reidpath DD. Unequal Access to Vaccines Will Exacerbate Other Inequalities. Asia Pac J Public Health. 2020 Sep-Oct;32(6-7):379-380. doi: 10.1177/1010539520944726. Epub 2020 Jul 25. No abstract available.
- Individual participant dataSharing planned: Yes. Anonymised data will be shared on Open Science Framework after the completion of the study and once the results have been published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rumaya Binti Juhari, Dr principal investigator
Universiti Putra Malaysia
Liane Peña Alampay, Dr principal investigator
Ateneo de Manila University
Rosanne Jocson, Dr principal investigator
Ateneo de Manila University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ParentText in people with Engagement and Positive Parenting, run by University of Oxford at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient participants were recruited for the optimisation trial. Study procedures revised to conduct a pilot of intervention acceptability, feasibility, and preliminary change in psychosocial behavioural outcomes.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response to ParentText messages (time frame: Through study completion, an average of 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05003518, which also lists 69 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.