A hybrid digital parenting programme to prevent abuse of adolescents in Tanzania: statistical analysis plan for a pragmatic cluster randomised controlled trial.

Journal: Trials

Volume: 25

Issue: 1

Year of Publication: 2024

Affiliated Institutions:  Department of Social Policy and Intervention, University of Oxford, Oxford, UK. Jonathan.klapwijk@spi.ox.ac.uk. Faculty of Health and Life Sciences, University of Exeter, Exeter, UK. Centre for Social Science Research, University of Cape Town, Cape Town, South Africa. National Institute for Medical Research, Mwanza Research Centre, Mwanza, Tanzania. Department of Social Policy and Intervention, University of Oxford, Oxford, UK.

Abstract summary 

Globally, violence against children poses substantial health and economic challenges, with estimated costs nearing USD 7 trillion. This prompts the urgent call for effective evidence-based interventions in preventing and mitigating violence against children. ParentApp is a mobile, open-source application designed to offer a remote version of the Parenting for Lifelong Health (PLH) programme. ParentApp is the first digital parenting intervention for caregivers of adolescents aged 10-17 years to be tested in low- and middle-income settings.This study is a pragmatic, two-arm, cluster-randomised trial in Mwanza, Tanzania's urban and peri-urban areas. Assessments are set for baseline, 1 month post-intervention, and 12 months post-intervention. We randomised 80 clusters, each with about 30 caregiver-adolescent dyads, with a 1:1 ratio stratified by urban or peri-urban location. Both arms receive an entry-level smartphone preloaded with Kiswahili apps-ParentApp for intervention and WashApp control. The primary method of analysis will be generalised linear mixed-effects models with adjustment for person-level characteristics and multiple imputation. In three-level models, measurement waves are nested within a person, nested within a sub-ward. Regressions will constrain groups to be equal at baseline and include covariates for stratification, percentage of male caregivers, and individual-level characteristics.Preparations for the trial began in December 2022, including community mobilisation and sensitisation. Rolling recruitment, baseline data collection, and implementation onboarding took place between April and September 2023. One-month post-test data collection began in August 2023 and thus far achieved 97% and 94% retention rates for caregivers and adolescents respectively. Final post-test data collection will begin in September 2024, anticipated to run until April 2025. This SAP was submitted to the journal before the interim analysis to preserve scientific integrity under a superiority hypothesis testing framework.The trial was registered on the Open Science Framework on 14 March 2023: https://doi.org/10.17605/OSF.IO/T9FXZ . The trial protocol was published in Trials 25, 119 (2024): Baerecke, L., Ornellas, A., Wamoyi, J. et al. A hybrid digital parenting programme to prevent abuse of adolescents in Tanzania: study protocol for a pragmatic cluster-randomised controlled trial. Trials 25, 119 (2024). https://doi.org/10.1186/s13063-023-07893-x .

Authors & Co-authors:  Klapwijk Jonathan J Melendez-Torres G J GJ Ornellas Abigail A Wambura Mwita M Chetty Angelique N AN Baerecke Lauren L Wamoyi Joyce J Cluver Lucie D LD

Study Outcome 

Source Link: Visit source

Statistics
Citations :  Hillis S, Mercy J, Amobi A, Kress H. Global prevalence of past-year violence against children: a systematic review and minimum estimates. Pediatrics. 2016;137:e20154079. doi: 10.1542/peds.2015-4079.
Authors :  8
Identifiers
Doi : 446
SSN : 1745-6215
Study Population
Male
Mesh Terms
Humans
Other Terms
Adolescents;Child abuse;Digital;Low- and middle-income countries;Parenting;Violence against children
Study Design
Study Approach
Mixed Methods
Country of Study
Tanzania
Publication Country
England