Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202210657553944 Date of Approval: 11/10/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Optimising engagement in a digital parenting intervention to prevent violence against adolescents in Tanzania: A cluster randomised factorial trial
Official scientific title A pragmatic cluster randomised full factorial trial to evaluate the effectiveness, cost-effectiveness, and feasibility of three intervention components designed to maximise engagement in an open-source parenting application deployed among socioeconomically vulnerable caregivers of adolescents in Tanzania
Brief summary describing the background and objectives of the trial This trial employs a cluster factorial experiment and a novel mixed-methods analytic approach to assess the effectiveness, cost-effectiveness, and feasibility of intervention components designed to optimise engagement in an open-source parenting app, ParentApp for Teens. The app is based on the evidence-based Parenting for Lifelong Health for Teens programme. The study will be conducted in low-income communities in Mwanza, Tanzania, targeting vulnerable caregivers of adolescents aged 10 to 17 years. We will randomise 16 neighbourhoods, i.e., clusters, to one of 8 experimental conditions which consist of any combination of three intervention components (support: self-guided/facilitated WhatsApp groups; app design: sequential workshops/non-sequential modules; digital literacy training: high/low). The objective of this study is to estimate the main effects of the three intervention components on engagement. Secondary objectives are to test the interactions between components, the effects of the intervention components on caregiver behavioural outcomes, and moderators and mediators of programme engagement and impacts. The study will also assess enablers and barriers to engagement qualitatively via interviews with low, medium and high engaging participants. At the end of the trial, we will combine quantitative and qualitative data to develop an optimised version of the delivery package. First, we will select component levels that have the highest level of effectiveness in terms of engagement. If a component level has a main effect, its cost-effectiveness will be examined. We will then draw on qualitative findings to examine the acceptability and feasibility of the retained component level in order to identify an intervention package for ParentApp for Teens which is optimally effective, cost-effective and feasible for low-income families in Tanzania. The optimised intervention will subsequently be evaluated in a 2-arm cluster RCT.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Violence Against Adolescents
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 18/10/2022
Actual trial start date 21/10/2022
Anticipated date of last follow up 31/03/2023
Actual Last follow-up date 23/03/2023
Anticipated target sample size (number of participants) 640
Actual target sample size (number of participants) 614
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Parenting for Lifelong Health ParentApp for Teens Support: Self-guided; App design: Non-sequential; Digital literacy training: On The non-sequential version of ParentApp for Teens is a 12-module intervention lasting approximately 12 weeks. The Digital literacy training occurs once at the onboarding session and will take under 1 hour to deliver. 1. Support – Self-guided: 12 modules of the ParentApp for Teens intervention delivered without any additional support from a trained facilitator. 2. App design – Non-sequential: ParentApp for Teens is a module-based design where content is broken down into smaller tasks and participants can access content in a non-sequential manner. 3. Digital literacy training – On: Participants receive a brief, structured digital literacy training at the group-based onboarding session after they have provided consent to participate in the study. The training will cover content on online safety, communication platforms, and accessibility and awareness, and will take a participatory learning-based approach. 80
Experimental Group Parenting for Lifelong Health ParentApp for Teens Support: self-guided; App design: Non-sequential; Digital literacy training: Off The non-sequential version of ParentApp for Teens is a 12-module intervention lasting approximately 12 weeks. 1. Support – Self-guided: 12 modules of the ParentApp for Teens intervention delivered without any additional support from a trained facilitator. 2. App design – Non-sequential: ParentApp for Teens is a module-based design where content is broken down into smaller tasks and participants can access content in a non-sequential manner. 3. Digital literacy training – Off: Participants do not receive a structured digital literacy training at the group-based onboarding session after they have provided consent to participate in the study. 80
Experimental Group Parenting for Lifelong Health ParentApp for Teens Support: Self-guided; App design: Sequential; Digital literacy training: On The sequential version of ParentApp for Teens is a 12-workshop intervention where a new workshop is released to participants once a week for a duration of 12 weeks. The Digital literacy training occurs once at the onboarding session and will take under 1 hour to deliver. 1. Support – Self-guided: 12 workshops of the ParentApp for Teens intervention delivered without any additional support from a trained facilitator. 2. App design – Sequential: ParentApp for Teens is a workshop-based design where participants access content in a sequential and time-bound manner. 3. Digital literacy training – On: Participants receive a brief structured digital literacy training at the group-based onboarding session after they have provided consent to participate in the study. The training will cover content on online safety, communication platforms, and accessibility and awareness, and will take a participatory learning-based approach. 80
Experimental Group Parenting for Lifelong Health ParentApp for Teens Support: Self-guided; App design: Sequential; Digital literacy training: Off The sequential version of ParentApp for Teens is a 12-workshop intervention where a new workshop is released to participants once a week for a duration of 12 weeks. 1. Support – Self-guided: 12 workshops of the ParentApp for Teens intervention delivered without any additional support from a trained facilitator. 2. App design – Sequential: ParentApp for Teens is a workshop-based design where participants access content in a sequential and time-bound manner. 3. Digital literacy training – Off: Participants do not receive a structured digital literacy training at the group-based onboarding session after they have provided consent to participate in the study. 80
Experimental Group Parenting for Lifelong Health ParentApp for Teens Support: WhatsApp group; App design: Non-sequential; Digital literacy training: On The non-sequential version of ParentApp for Teens is a 12-module intervention lasting approximately 12 weeks. In addition, participants receive weekly WhatsApp group support from a trained facilitator lasting approximately 2 hours per week. The Digital literacy training occurs once at the onboarding session, lasting less than 1 hour. 1. Support – WhatsApp group: 12 modules of the ParentApp for Teens intervention delivered alongside additional support via WhatsApp groups of approximately 30 to 40 participants per group, moderated by a local trained facilitator. 2. App design – ParentApp for Teens is a module-based design where content is broken down into smaller tasks and participants can access content in a non-sequential manner. 3. Digital literacy training – On: Participants receive a brief structured digital literacy training at the group-based onboarding session after they have provided consent to participate in the study. The training will cover content on online safety, communication platforms, and accessibility and awareness, and will take a participatory learning-based approach. 80
Experimental Group Parenting for Lifelong Health ParentApp for Teens Support: WhatsApp group; App design: Non-sequential; Digital literacy training: Off The non-sequential version of ParentApp for Teens is a 12-module intervention lasting approximately 12 weeks. In addition, participants receive weekly WhatsApp group support from a trained facilitator lasting approximately 2 hours per week. 1. Support – WhatsApp group: 12 modules of the ParentApp for Teens intervention delivered alongside additional support via WhatsApp groups of approximately 30 to 40 participants per group, moderated by a local trained facilitator. 2. App design – Non-sequential: ParentApp for Teens is a module-based design where content is broken down into smaller tasks and participants can access content in a non-sequential manner. 3. Digital literacy training – Off: Participants do not receive a structured digital literacy training at the group-based onboarding session after they have provided consent to participate in the study. 80
Experimental Group Parenting for Lifelong Health ParentApp for Teens Support: WhatsApp group; App design: Sequential; Digital literacy training: On The sequential version of ParentApp for Teens is a 12-workshop intervention where a new workshop is released to participants once a week for a duration of 12 weeks. In addition, participants receive weekly WhatsApp group support from a trained facilitator lasting approximately 2 hours per week. The Digital literacy training occurs once at the onboarding session, lasting less than 1 hour. 1. Support – WhatsApp group: 12 workshops of the ParentApp for Teens intervention delivered alongside additional support via WhatsApp groups of approximately 30 to 40 participants per group, moderated by a local trained facilitator. 2. App design – Sequential: ParentApp for Teens is a workshop-based design where participants access content in a sequential and time-bound manner. 3. Digital literacy training – On: Participants receive a brief structured digital literacy training at the group-based onboarding session after they have provided consent to participate in the study. The training will cover content on online safety, communication platforms, and accessibility and awareness, and will take a participatory learning-based approach. 80
Experimental Group Parenting for Lifelong Health ParentApp for Teens Support: WhatsApp group; App design: Sequential; Digital literacy training: Off The sequential version of ParentApp for Teens is a 12-workshop intervention where a new workshop is released to participants once a week for a duration of 12 weeks. In addition, participants receive weekly WhatsApp group support from a trained facilitator lasting approximately 2 hours per week. 1. Support – WhatsApp group: 12 workshops of the ParentApp for Teens intervention delivered alongside additional support via WhatsApp groups of approximately 30 to 40 participants per group, moderated by a local trained facilitator. 2. App design – Sequential: ParentApp for Teens is a workshop-based design where participants access content in a sequential and time-bound manner. 3. Digital literacy training – Off: Participants do not receive a structured digital literacy training at the group-based onboarding session after they have provided consent to participate in the study. 80
Control Group Not applicable for this study NA NA NA 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria for parents/caregivers: 1. Age 18 or older; 2. Primary caregiver of a teenager aged 10 to 17 years; 3. Live in the same household as the target teenager for at least four nights per week in the previous month; 4. Have regular access to an Android smartphone; 5. Provide written informed consent. Exclusion criteria for parents/caregivers: 1. Any adult who is unable to read or who has a severe learning disability that affects their ability to give informed consent. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/06/2022 The University of Oxfords Departmental Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Barnett House, 32 Wellington Square Oxford OX1 2ER United Kingdom
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/12/2021 National Institute for Medical Research Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive Dar es Salaam 9653 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Overall number of app-opens throughout the intervention Throughout the intervention period
Primary Outcome Number of workshops or modules completed (score ranging from 0 to 12) Throughout the intervention period
Primary Outcome Number of home practice activities started (score ranging from 0 to 10) Throughout the intervention period
Secondary Outcome Overall time spent on the app throughout the intervention Throughout the intervention period
Secondary Outcome Number of workshops or modules started scoring 0 - 12 Throughout the intervention period
Secondary Outcome Total number of ParentPoints (self-reported habit tracker) logged throughout the intervention Throughout the intervention period
Secondary Outcome Child maltreatment (exploratory outcome, moderator) Four items adapted from the reduced version of the ISPCAN Child Abuse Screening Tool-Trial Parent Version (Meinck et al., 2018) will be used to assess child maltreatment. The tool asks caregivers to report the frequency of emotional abuse (2 items, e.g., “shout, scream or yell” and “insult or call names or stupid”) and physical abuse (2 items, “hitting, spanking or slapping with a hand or with an object like a stick or belt” and “discipline with a push or grab”) over the past month using a scale of 0 to 8 or more times. Items sum to create a score for each subscale as well as a total child maltreatment score. Pre-intervention and post-intervention
Secondary Outcome Positive parenting (exploratory outcome, moderator) Five items from the Alabama Parenting Questionnaire (Essau et al., 2006) will be used to assess positive parenting. Caregivers will be asked to give a frequency score of their behaviours towards their adolescents in the past month on a scale of 0 to 8 or more times. The tool measures positive parenting (1 item, “how many times have you praised your teen?”), involved parenting (1 item, “get involved in activities that your teen likes”, and parental supervision (3 items, e.g., “stay out in the evening past the time they are supposed to be home”). Items sum to create a total positive parenting score as well as a score for the parental supervision subscale. Pre-intervention and post-intervention
Secondary Outcome Parental communication about sexual risk prevention (exploratory outcome, moderator) Three items adapted from the Parent Teen Sexual Risk Communication Scale III (Hutchinson, 2007) will be used to assess adolescent sexual risk behaviour and caregiver communication about sexual risk prevention. One item asks, “how many times in the past month has your teen walked home alone, taken a lift with someone they don’t know or hung out in a place that made you worried for their safety?”. Caregivers respond on a frequency scale ranging from 0 to 8 or more times. Risk scenarios were adapted based on high-risk scenarios in Tanzania, in discussion with local researchers and based on available evidence. The other item asks, “have you ever talked with your teen about ways to avoid being touched or made to do sexual things with people or online?”. Caregivers respond yes or no. If they respond yes, they will be asked “how many times in the past month have you had a talk like this?”. Caregivers are asked to respond on a frequency ranging from 0 to 8 or more times. Pre-intervention and post-intervention
Secondary Outcome Parental depression (moderator) Three items from the Centre for Epidemiologic Studies Depression Scale (CES-D 10) (Irwin et al., 1999) will be used to assess caregiver depression. The items ask caregivers to respond how they have felt in the previous week (3 items, e.g., “felt that everything you did was an effort”). Caregivers respond on a frequency scale ranging from 0 to 7 days. Items are summed with higher scores indicating greater parental depression. Pre-intervention and post-intervention
Secondary Outcome Parenting stress (moderator) One item adapted from the Parenting Stress Scale (Berry & Jones, 1995) will be used to assess caregiver stress. The item asks, “how many times in the past month did caring for your children make you feel very stressed” The items will be rated on a frequency scale of 0 to 8 or more times. Pre-intervention and post-intervention
Secondary Outcome Financial stress (moderator) Financial stress will also be assessed using two items adapted from the Financial Self-Efficacy Scale (Lown, 2011). One item asks, “how many times in the past month have you felt very worried or anxious about money?”. Caregivers respond on a frequency score, on a scale of 0 to 8 or more times. The second item assesses food insecurity “how many days (out of 30) did you run out of money to pay for food?”. Pre-intervention and post-intervention
Secondary Outcome Cost outcomes (cost analyses) Costs related to two of the three intervention components will be considered in this study. These include all costs associated with delivering the support component of the intervention, as well as the digital literacy training component. These costs will be collected by the relevant implementing staff using cost diaries. Costs will include money and time spent on programme delivery, i.e. materials and staff-time required for training, preparation, delivery, and coordination of activities. Costs associated with the development of the app are being excluded, since real-world deployments will effectively happen at zero-marginal cost, excluding the cost associated with content adaption. This is because the app has been developed to be completely self-contained, such that no additional supporting infrastructure is needed for routine rollout. In addition, costs incurred by participants (e.g., time spent using the app), and the evaluation of the intervention will be excluded from analyses, as the focus of this study is to understand scale-up cost, feasibility and effectiveness. Throughout the intervention period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Institute for Medical Research Tanzania P.O. BOX 1462 Mwanza United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
United Kingdom Research and Innovation Global Challenges Research Fund 58 Victoria Embarkment London United Kingdom
The LEGO Foundation 8 Hojmarksvej Billund Denmark
The Oak Foundation 58 Avenue Louis Casai Geneva Swaziland
The Wellspring Philanthropic Fund 10 Times Square 1441 Broadway New York United States of America
The European Research Council 1210 Sint-Joost-ten-Node Brussels Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Oxford Barnett House, 32 -37 Wellington Square Oxford United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
University of Oxford Barnett House, 32 -37 Wellington Square Oxford United Kingdom
University of Cape Town Robert Leslie Social Science Building 12 University Avenue South Cape Town South Africa
National Institute for Medical Research P.O. BOX 1462 Mwanza United Republic of Tanzania
Investing in Children and Strengthening their Societies P.O. Box 1195 Shinyanga United Republic of Tanzania
Clowns Without Borders South Africa 101 Alan Paton Ave Pietermaritzburg South Africa
Innovations in Development Education and the Mathematical Sciences International 15 Warwick Road Reading United Kingdom
Innovations in Development Education and the Mathematical Sciences Kenya Webuye Road Kakamega Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lucie Cluver lucie.cluver@spi.ox.ac.uk +441865280370 Barnett House, 32 -37 Wellington Square
City Postal code Country Position/Affiliation
Oxford United Kingdom Professor University of Oxford
Role Name Email Phone Street address
Principal Investigator Joyce Wamoyi j.wamoyi@gmail.com +255752145910 P.O. BOX 1462
City Postal code Country Position/Affiliation
Mwanza United Republic of Tanzania National Institute for Medical Research Tanzania
Role Name Email Phone Street address
Scientific Enquiries Roselinde Janowski roselinde.janowski@spi.ox.ac.uk +447762241955 Barnett House, 32 -37 Wellington Square
City Postal code Country Position/Affiliation
Oxford United Kingdom PhD candidate University of Oxford
Role Name Email Phone Street address
Public Enquiries Roselinde Janowski roselinde.janowski@spi.ox.ac.uk +447762241955 Barnett House, 32 -37 Wellington Square
City Postal code Country Position/Affiliation
Oxford United Kingdom PhD candidate University of Oxford
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Anonymised datasets will be made available via an open-access repository such as the Open Science Framework and a link to summary results will be made available within the trial registration record. Analytic Code,Clinical Study Report Additional documents including the summary of results and analytic code will be made available within 12 months of the study completion date. ParentApp for Teens is freely available and open source online. Anonymised datasets will be made available via an open-access repository such as the Open Science Framework.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 22/05/2023 Trial start date has now been updated 21 Oct 2022
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 22/05/2023 Trial completion date has been updated 23 Mar 2023
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 22/05/2023 Recruitment was slightly lower than the target number due to limited smartphone ownership in the targeted communities 614
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 22/05/2023 The trial has now been completed and data cleaning and analysis is underway Not yet recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 22/05/2023 This outcome was measured automatically assessed within the app at the start of the activity and was not self-reported. Last minute changes also included 10 not 11 overall activities. Primary Outcome, Self-reported number of home practice activities completed (score ranging from 0 to 11), Throughout the intervention period Primary Outcome, Number of home practice activities started (score ranging from 0 to 10), Throughout the intervention period
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 22/05/2023 Changes to the secondary engagement outcome were made in alignment with protocol revisions prior to the start of data analysis Secondary Outcome, Average percentage of content completed over each of the 12 workshops/modules, Throughout the intervention period Secondary Outcome, Number of workshops or modules started scoring 0 - 12 , Throughout the intervention period