Intimate Partner Violence Clinical Trial
Official title:
ParentText User Engagement and Effectiveness Study
Verified date | April 2024 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Malaysia | Family and Child Ecology at the Department of Human Development and Family Studies | Putrajaya | Putraja |
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 |
Malaysia,
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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 |
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