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Protocol for a cluster randomised controlled trial evaluating a parenting with home visitation programme to prevent physical and emotional abuse of children in Indonesia: the Families First Programme
  1. Mónica Ruiz-Casares1,2,
  2. Sarah Lilley3,
  3. Brett D Thombs1,4,
  4. Robert William Platt5,6,
  5. Susan Scott5,
  6. Widjajanti Isdijoso7,
  7. Emmy Hermanus7,
  8. Michelle Andrina7,
  9. Nancy Mayo5,8
  1. 1 Department of Psychiatry, McGill University, Montreal, Quebec, Canada
  2. 2 CIUSSS du Centre-Ouest-de-l'île-de-Montréal, SHERPA University Institute, Montreal, Quebec, Canada
  3. 3 Child Protection, Save the Children, London, UK
  4. 4 Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada
  5. 5 Research Institute, McGill University Health Centre, Montreal, Quebec, Canada
  6. 6 Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada
  7. 7 SMERU Research Institute, Jakarta, Indonesia
  8. 8 Department of Medicine, Faculty of Medicine, School of Physical and Occupational Therapy, McGill University, Montreal, Quebec, Canada
  1. Correspondence to Dr Mónica Ruiz-Casares; monica.ruizcasares{at}


Introduction Every year, up to 1 billion children are victims of violence worldwide. Most child abuse takes place in the context of punishment. The Families First Programme, an adaptation of the Positive Discipline in Everyday Parenting Programme to the West Java context, is a parenting support programme anchored on children’s rights that gives parents guidance on child development, parenting and positive discipline practices. This trial will evaluate the effectiveness of the Families First Programme compared with a waitlist control group.

Methods and analysis This is a pragmatic, parallel-group, stratified, cluster-randomised controlled trial. Twenty rural and urban villages in the Cianjur District, Indonesia, involving 720 caregivers of children up to 7 years of age, will be randomised. Villages will receive either a parenting programme consisting of 10 group sessions and four home visits over 3 months and standard community health and social services or just the latter. After completion of the trial period, the programme will be offered to those in the delayed group. Outcome data will be collected before randomisation (baseline), immediately postintervention (3 months postrandomisation) and 6 months later (9 months postrandomisation). The primary outcome will be frequency of physical and emotional punishment as measured by a weighted sum from three self-report items. Primary outcome analysis will use Poisson regression with generalised estimating equations and assess the interaction between intervention and time over baseline and 3 and 9 months postrandomisation assessments. Concurrent process evaluation will be conducted to assess programme satisfaction and facilitators and barriers to the implementation of the programme generalisable to other settings.

Ethics and dissemination Ethics approval was obtained from McGill University and Universitas Katolik Indonesia Atma Jaya. Results will be published in peer-reviewed journals and presented at scientific conferences and events for decision-makers, including in the participating communities.

Trial registration number NCT03374761.

  • child protection
  • epidemiology
  • public health
  • qualitative research

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  • Contributors MRC and SL conceived the study and drafted the original grant proposal. MRC drafted an extensive study protocol and the manuscript for publication. NM provided overall guidance in RCT design, contributed to the development of the extensive study protocol, performed sample size calculations and registered the trial. BDT and RWP provided overall guidance in RCT design and statistical guidance in the development of the protocol. SS planned the statistical analyses. WI provided feedback on study design and liaised with advisory committee. EH and MA participated in the adaptation of the trial methods to the local context and have responsibilities for day-to-day running of the trial. SL contributed to the conceptualisation of the study and to securing funding. All authors read and approved the final version of the manuscript.

  • Funding This work is supported by Save the Children Fund (no assigned grant number) and the Children and Violence Evaluation Challenge Fund (grant number 058), a joint initiative funded by the Bernard van Leer Foundation, Oak Foundation, UBS Optimus Foundation and an anonymous donor and hosted by the Network of European Foundations (NEF).

  • Disclaimer The sole responsibility for the content lies with the authors and the content may not necessarily reflect the positions of NEF/Children and Violence Evaluation Challenge Fund or the sponsoring foundations. SL and the funding sponsors will have no role in the collection, analyses or interpretation of data; and in the writing and decision to publish the results.

  • Competing interests All coauthors report grants from Children and Violence Evaluation Challenge Fund–Network of European Foundations and from Save the Children Fund, during the conduct of the study. RWP reports personal fees from AbbVie, Amgen, Eli Lilly, Pfizer and Searchlight Pharma, outside the submitted work.

  • Patient consent Not required.

  • Ethics approval Study protocols were approved by the Faculty of Medicine Institutional Review Board, McGill University (A10-B53-16B), the Universitas Katolik Indonesia Atma Jaya Research Ethics Committee (/III/LPPM-PM.10.05/01/2017), the Indonesian Ministry of Home Affairs, and the provincial and district governments.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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