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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607510907022 Date of Registration: 28/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title ParentText Optimization Trial: A Factorial Randomized Controlled Trial to Optimize User Engagement With a Chatbot-Led Parenting Intervention in South Africa
Official scientific title A Factorial Randomized Controlled Trial to Optimize User Engagement With a Chatbot-Led Parenting Intervention: Protocol for the ParentText Optimization Trial
Brief summary describing the background and objectives of the trial Violence against children (VAC) is a serious public health concern with long-lasting adverse effects. Evidence-based parenting programs are effective in preventing VAC; however, these interventions are not scalable in their typical in-person group format, particularly in low- and middle-income countries. Digital delivery via chatbots offers a scalable and cost-effective approach, yet user engagement remains a key challenge. The ParentText Optimization Trial aims to optimize user engagement with ParentText, an open-source chatbot-led parenting intervention delivered to parents and their adolescent girls aged 10 to 17 years in South Africa. Using a 2 × 2 factorial cluster-randomized experimental design derived from the Multiphase Optimization Strategy (MOST) framework, the study will test the effectiveness and cost-effectiveness of two externally delivered components: (1) in-person sessions (1 vs 4 sessions) and (2) facilitated WhatsApp support groups (yes vs no). The primary objective is to examine the effectiveness and cost-effectiveness of these component levels on engagement outcomes, including the total number of modules completed in ParentText.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ParentText Optimization Trial
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 21/08/2023
Actual trial start date 21/08/2023
Anticipated date of last follow up 08/09/2023
Actual Last follow-up date 10/11/2023
Anticipated target sample size (number of participants) 3280
Actual target sample size (number of participants) 1970
Recruitment status Completed
Publication URL https://doi.org/10.2196/52145
Secondary Ids Issuing authority/Trial register
WFXNE Open Science Framework - preregistration submitted on 17 August 2023, prior to enrolment.
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 Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group ParentText plus 1 In Person Session ParentText chatbot delivered continuously (“always on”) plus 1 in-person onboarding session with parents and adolescent girls. ParentText available throughout the intervention period (6 weeks) plus one in-person session at the start of the intervention. ParentText is an open-source chatbot-led parenting intervention delivering personalized and gamified scheduled and on-demand messages through text, audio, and visual media based on developmental stages for parents of adolescent girls aged 10 to 17 years. In this condition, participants receive ParentText combined with one in-person session focused on onboarding to the chatbot. The in-person session is delivered by a designated community-based facilitator and introduces parents and adolescents to the chatbot platform and its use. No facilitated WhatsApp support groups are provided in this condition. 960 Dose Comparison
Experimental Group ParentText plus 1 In Person Session plus Facilitated WhatsApp Group ParentText chatbot plus 1 in-person onboarding session and six moderated WhatsApp support group sessions for parents. ParentText available throughout the intervention period (6 weeks); one in-person onboarding session at initiation; six moderated WhatsApp group sessions delivered during the intervention period. Participants receive ParentText combined with one in-person onboarding session and facilitated WhatsApp support groups. The WhatsApp groups are moderated by an m2m facilitator and provide structured remote support to enhance user engagement with ParentText. 960
Experimental Group ParentText plus 4 In Person Session ParentText chatbot plus four in-person sessions (first session includes onboarding). ParentText available throughout the intervention period (6 weeks); four in-person sessions delivered during the intervention period. Participants receive ParentText combined with four in-person sessions delivered by a community-based facilitator. The first session focuses on onboarding to the chatbot, and the remaining sessions provide additional structured support to enhance engagement. No WhatsApp support groups are provided in this condition. 960
Experimental Group ParentText plus 4 In Person Session plus Facilitated WhatsApp Group ParentText chatbot plus four in-person sessions and six moderated WhatsApp support group sessions. ParentText available throughout the intervention period (6 weeks); four in-person sessions and six WhatsApp group sessions delivered during the intervention period. Participants receive ParentText combined with four in-person sessions and facilitated WhatsApp support groups. This represents the most intensive engagement package tested in the 2 × 2 factorial design. 960
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Parent or caregiver aged ≥ 18 years. Parent/caregiver is an English, isiZulu, or siSwati speaker. Parent/caregiver is currently caring for an adolescent girl aged 10–17 years. Parent/caregiver resides in the same household as the adolescent girl for at least 4 nights per month over the previous 3 months. Parent/caregiver has access to a mobile phone compatible with WhatsApp. Parent/caregiver is willing to enroll in the ParentText chatbot and receive messages via WhatsApp. Parent/caregiver provides written informed consent to participate in the study. Eligible adolescents: female teenagers aged 10–17 years who have a parent enrolled in the trial and who provide written informed assent. Eligible clusters: communities with at least 60 households with a resident adolescent girl aged 10–17 years and assigned to an m2m CHAMP implementer. Parent/caregiver younger than 18 years. Parent/caregiver not an English, isiZulu, or siSwati speaker. Parent/caregiver not currently caring for an adolescent girl aged 10–17 years. Parent/caregiver does not reside with the adolescent girl for ≥ 4 nights/month over the previous 3 months. Parent/caregiver does not have a mobile phone compatible with WhatsApp. Parent/caregiver unwilling to enroll in ParentText or to receive messages via WhatsApp. Parent/caregiver does not provide written informed consent. Adolescents who are not female, outside 10–17 years, or whose parent is not enrolled or who do not assent. Clusters that do not have ≥ 60 households with an eligible adolescent girl or are not assigned to an m2m CHAMP implementer. Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 99 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 16/08/2023 Social Science and Humanities Interdivisional Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Churchill Drive Oxford OX3 7GB 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 04/07/2023 CSSR Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
12 University Avenue Cape Town 7701 United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Overall number of modules completed within the ParentText chatbot 6 weeks post-baseline
Secondary Outcome Percentage of modules and goals completed 6 weeks post-baseline
Secondary Outcome Rate of self-reported completion of home practice activities 6 weeks post-baseline
Secondary Outcome Engagement Outcome - Number of days users interact with the chatbot 6 weeks post-baseline
Secondary Outcome Engagement Outcome - Number of triggered safeguarding messages 6 weeks post-baseline
Secondary Outcome Engagement Outcome - Number of active and passive dropout from the chatbot 6 weeks post-baseline
Secondary Outcome Engagement Outcome - Number of times users use the menu and option functions 6 weeks post-baseline
Secondary Outcome Engagement Outcome - Number of times users access learning through play activities and type of activity (ie, calm, active, quick, or group) 6 weeks post-baseline
Secondary Outcome Engagement Outcome - Type of media selected for engagement (ie, text, audio, or video) 6 weeks post-baseline
Secondary Outcome Engagement Outcome - Goal selected by users after completion of the first goal 6 weeks post-baseline
Secondary Outcome Behavioral and Mental Health Outcome - Child maltreatment (adult and adolescent report) will be assessed using a subset of items from the physical abuse (2 items) and emotional abuse (2 items) subscales of the International Society for the Prevention of Child Abuse and Neglect Child Abuse Screening Tool–Trial Version. Baseline and 6 weeks post-baseline
Secondary Outcome Behavioral and Mental Health Outcome - Positive parenting (adult and adolescent report) will be assessed using a subset of items from the positive involvement (3 items), positive parenting (3 items), and parental supervision (3 items) subscales of the Alabama Parenting Questionnaire. Baseline and 6 weeks post-baseline
Secondary Outcome Behavioral and Mental Health Outcome - Parent support of education (adult and adolescent report) will be measured using 4 items assessing how often the parent engages the adolescent in behaviors that support learning. Baseline and 6 weeks post-baseline
Secondary Outcome Behavioral and Mental Health Outcome - Mental health distress (adult and adolescent report) will be measured using the 4-item Patient Health Questionnaire, which screens for anxiety and depression symptoms. Baseline and 6 weeks post-baseline
Secondary Outcome Behavioral and Mental Health Outcome - Parenting stress (adult report only) will be measured using the parental stressors subscale (6 items) of the Parental Stress Scale. Baseline and 6 weeks post-baseline
Secondary Outcome Behavioral and Mental Health Outcome - Economic strengthening (adult report only) will be measured using 1 item from the Financial Self-Efficacy Scale. Baseline and 6 weeks post-baseline
Secondary Outcome Behavioral and Mental Health Outcome - Parent-child communication (adult report only) will be measured using items adapted from the Parent-Child Communication Scale used in the Fast Track intervention study. Baseline and 6 weeks post-baseline
Secondary Outcome Behavioral and Mental Health Outcome - Learning through play (adult report only) will be assessed using a subset of items from the Alabama Parenting Questionnaire, the Parent-Child Communication Scale, and the items on parent support of education. The selected scales will overarch the learning through play characteristics evidenced in the literature. Parents will report the frequency of parent-child engagement. Baseline and 6 weeks post-baseline
Secondary Outcome Behavioral and Mental Health Outcome - Intimate partner relationships (adult report only) will be investigated by assessing gender-equitable behavior. Gender-equitable behavior will be measured using items adapted from the core questionnaire in the World Health Organization multicountry study on domestic violence and from questionnaires used in previous violence prevention studies. Baseline and 6 weeks post-baseline
Secondary Outcome Behavioral and Mental Health Outcome - Risk avoidance (adolescent report only) will be assessed using 4 locally derived items on risk. Baseline and 6 weeks post-baseline
Secondary Outcome Behavioral and Mental Health Outcome - Adolescent involvement in decision-making (adolescent report only) will be assessed to investigate to what extent adolescents’ voices are heard within families regarding decisions affecting their lives. A total of 3 items adapted from questionnaires used in previous research on parent-child engagement in decision-making will be used to assess adolescent involvement in decisions related to their education, daily activities, and money expenditure in the household. Baseline and 6 weeks post-baseline
Secondary Outcome Behavioral and Mental Health Outcome - Attitude toward punishment (adult and adolescent report) will be assessed using a single item from the UNICEF Multiple Indicator Cluster Surveys 5 child discipline module. Baseline and 6 weeks post-baseline
Secondary Outcome Cultural Determinants of Engagement – Technology Acceptance Model constructs (perceived ease of use, perceived usefulness, hedonic motivation, habit, price value, and social influence) measured using the Technology Acceptance Model 1 scale (16 items) (parent report only). Immediately after in-person onboarding session
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
mothers2mothers CHAMP Programme Mpumalanga Provincial Office Office 102 1st Floor Bi Water Building 16 Nel Street Mbombela 1201 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
LEGO Foundation Hojmarksvej 8 Billund 7190 Denmark
Oak Foundation 58 Avenue Louis Casai Geneva 1216 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Oxford Department of Social Policy and Intervention 32 Wellington Square Oxford OX1 2ER United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
University of Cape Town Centre for Social Science Research 12 University Avenue Cape Town 7701 South Africa
Parenting for Lifelong Health 32 Wellington Square Oxford OX1 2ER United Kingdom
Clowns Without Borders South Africa 101 Alan Paton Avenue Pietermaritzburg 3209 South Africa
IDEMS International 15 Warwick Road Reading RG2 7AX United Kingdom
University of Fort Hare Public Health Department Faculty of Health Sciences 50 Church Street East London 5200 South Africa
University of Exeter Faculty of Health and Life Sciences 79 Heavitree Rd Exeter EX2 4TH United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jamie Lachman jamie.lachman@spi.ox.ac.uk +441865270325 32 Wellington Square
City Postal code Country Position/Affiliation
Oxford OX1 2ER United Kingdom Professor of Child and Family Global Health
Role Name Email Phone Street address
Public Enquiries Jamie Lachman jamie.lachman@spi.ox.ac.uk +441865270325 32 Wellington Square
City Postal code Country Position/Affiliation
Oxford OX1 2ER United Kingdom Professor of Child and Family Global Health
Role Name Email Phone Street address
Scientific Enquiries Inge Vallance inge.vallance@spi.ox.ac.uk +4401865280336 32 Wellington Square
City Postal code Country Position/Affiliation
Oxford OX1 2ER United Kingdom Head of Research
Role Name Email Phone Street address
Principal Investigator Hlengiwe Gwebu HGwebu@ufh.ac.za +27673076018 5 Oxford Building, Oxford Street
City Postal code Country Position/Affiliation
East London 5201 South Africa Senior Lecturer at the University of Fort Hare and coPI of this study
Role Name Email Phone Street address
Scientific Enquiries Zamakhanya Makhanya zamakhanya.makhanya@uct.ac.za +27828880370 Room 4.89, Robert Leslie Social Science Building, 12 University Avenue, University of Cape Town
City Postal code Country Position/Affiliation
Cape Town 7701 South Africa Research Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data underlying the results reported in publications will be made available 12 months following publication of the primary results via controlled access, following review and approval of a data access request. Analytic Code,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be available beginning 12 months following publication of the primary results. Requests for access will require submission of a brief description of the intended use. Requests will be reviewed by the study team. Access will be granted following approval of the request and completion of appropriate data access procedures.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
10.17605/OSF.IO/WFXNE Yes 15/07/2026
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 15/07/2026
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://www.researchprotocols.org/2024/1/e52145/
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 21/07/2026 We were asked to include a South African-based contact person since the study was conducted in South Africa. Principal Investigator, Hlengiwe, Gwebu, Dr., HGwebu@ufh.ac.za, , +27673076018, 5 Oxford Building, Oxford Street, East London, , South Africa, Senior Lecturer at the University of Fort Hare and coPI of this study
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 21/07/2026 We were asked to include a South African-based contact person since the study was conducted in South Africa. Principal Investigator, Hlengiwe, Gwebu, Dr., HGwebu@ufh.ac.za, , +27673076018, 5 Oxford Building, Oxford Street, East London, , South Africa, Senior Lecturer at the University of Fort Hare and coPI of this study Principal Investigator, Hlengiwe, Gwebu, Dr., HGwebu@ufh.ac.za, , +27673076018, 5 Oxford Building, Oxford Street, East London, 5201, South Africa, Senior Lecturer at the University of Fort Hare and coPI of this study
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 21/07/2026 We were asked to include a South African-based contact person since the study was conducted in South Africa. Scientific Enquiries, Zamakhanya, Makhanya, Miss, zamakhanya.makhanya@uct.ac.za, , +27828880370, Room 4.89, Robert Leslie Social Science Building, 12 University Avenue, University of Cape Town, Cape Town, 7701, South Africa, Research Manager