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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.

ABSTRACT: 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.

SUBMITTER: Ruiz-Casares M

PROVIDER: S-EPMC6340427 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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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.

Ruiz-Casares Mónica M Lilley Sarah S Thombs Brett D BD Platt Robert William RW Scott Susan S Isdijoso Widjajanti W Hermanus Emmy E Andrina Michelle M Mayo Nancy N

BMJ open 20190115 1

<h4>Introduction</h4>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 Fi ...[more]

PMID: 30782674

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Project description:Objective:To assess the impact of 'Parenting for Lifelong Health: Sinovuyo Teen', a parenting programme for adolescents in low-income and middle-income countries, on abuse and parenting practices. Design:Pragmatic cluster randomised controlled trial. Setting:40 villages/urban sites (clusters) in the Eastern Cape province, South Africa. Participants:552 families reporting conflict with their adolescents (aged 10-18). Intervention:Intervention clusters (n=20) received a 14-session parent and adolescent programme delivered by trained community members. Control clusters (n=20) received a hygiene and hand-washing promotion programme. Main outcome measures:Primary outcomes: abuse and parenting practices at 1 and 5-9 months postintervention. Secondary outcomes: caregiver and adolescent mental health and substance use, adolescent behavioural problems, social support, exposure to community violence and family financial well-being at 5-9 months postintervention. Blinding was not possible. Results:At 5-9 months postintervention, the intervention was associated with lower abuse (caregiver report incidence rate ratio (IRR) 0.55 (95% CI 0.40 to 0.75, P<0.001); corporal punishment (caregiver report IRR=0.55 (95% CI 0.37 to 0.83, P=0.004)); improved positive parenting (caregiver report d=0.25 (95% CI 0.03 to 0.47, P=0.024)), involved parenting (caregiver report d=0.86 (95% CI 0.64 to 1.08, P<0.001); adolescent report d=0.28 (95% CI 0.08 to 0.48, P=0.006)) and less poor supervision (caregiver report d=-0.50 (95% CI -0.70 to -0.29, P<0.001); adolescent report d=-0.34 (95% CI -0.55 to -0.12, P=0.002)), but not decreased neglect (caregiver report IRR 0.31 (95% CI 0.09 to 1.08, P=0.066); adolescent report IRR 1.46 (95% CI 0.75 to 2.85, P=0.264)), inconsistent discipline (caregiver report d=-0.14 (95% CI -0.36 to 0.09, P=0.229); adolescent report d=0.03 (95% CI -0.20 to 0.26, P=0.804)), or adolescent report of abuse IRR=0.90 (95% CI 0.66 to 1.24, P=0.508) and corporal punishment IRR=1.05 (95% CI 0.70 to 1.57, P=0.819). Secondary outcomes showed reductions in caregiver corporal punishment endorsement, mental health problems, parenting stress, substance use and increased social support (all caregiver report). Intervention adolescents reported no differences in mental health, behaviour or community violence, but had lower substance use (all adolescent report). Intervention families had improved economic welfare, financial management and more violence avoidance planning (in caregiver and adolescent report). No adverse effects were detected. Conclusions:This parenting programme shows promise for reducing violence, improving parenting and family functioning in low-resource settings. Trial registration number:Pan-African Clinical Trials Registry PACTR201507001119966.

Project description:BackgroundMany countries now offer support to teenage mothers to help them to achieve long-term socioeconomic stability and to give a successful start to their children. The Family Nurse Partnership (FNP) is a licensed intensive home-visiting intervention developed in the USA and introduced into practice in England that involves up to 64 structured home visits from early pregnancy until the child's second birthday by specially recruited and trained family nurses. We aimed to assess the effectiveness of giving the programme to teenage first-time mothers on infant and maternal outcomes up to 24 months after birth.MethodsWe did a pragmatic, non-blinded, randomised controlled, parallel-group trial in community midwifery settings at 18 partnerships between local authorities and primary and secondary care organisations in England. Eligible participants were nulliparous and aged 19 years or younger, and were recruited at less than 25 weeks' gestation. Field-based researchers randomly allocated mothers (1:1) via remote randomisation (telephone and web) to FNP plus usual care (publicly funded health and social care) or to usual care alone. Allocation was stratified by site and minimised by gestation (<16 weeks vs ≥16 weeks), smoking status (yes vs no), and preferred language of data collection (English vs non-English). Mothers and assessors (local researchers at baseline and 24 months' follow-up) were not masked to group allocation, but telephone interviewers were blinded. Primary endpoints were biomarker-calibrated self-reported tobacco use by the mother at late pregnancy, birthweight of the baby, the proportion of women with a second pregnancy within 24 months post-partum, and emergency attendances and hospital admissions for the child within 24 months post-partum. Analyses were by intention to treat. This trial is registered with ISRCTN, number ISRCTN23019866.FindingsBetween June 16, 2009, and July 28, 2010, we screened 3251 women. After enrolment, 823 women were randomly assigned to receive FNP and 822 to usual care. All follow-up data were retrieved by April 25, 2014. 304 (56%) of 547 women assigned to FNP and 306 (56%) of 545 assigned to usual care smoked at late pregnancy (adjusted odds ratio [AOR] 0·90, 97·5% CI 0·64-1·28). Mean birthweight of 742 babies with mothers assigned to FNP was 3217·4 g (SD 618·0), whereas birthweight of 768 babies assigned to usual care was 3197·5 g (SD 581·5; adjusted mean difference 20·75 g, 97·5% CI -47·73 to 89·23. 587 (81%) of 725 assessed children with mothers assigned to FNP and 577 (77%) of 753 assessed children assigned to usual care attended an emergency department or were admitted to hospital at least once before their second birthday (AOR 1·32, 97·5% CI 0·99-1·76). 426 (66%) of 643 assessed women assigned to FNP and 427 (66%) 646 assigned to usual care had a second pregnancy within 2 years (AOR 1·01, 0·77-1·33). At least one serious adverse event (mainly clinical events associated with pregnancy and infancy period) was reported for 310 (38%) of 808 participants (mother-child) in the usual care group and 357 (44%) of 810 in the FNP group, none of which were considered related to the intervention.InterpretationAdding FNP to the usually provided health and social care provided no additional short-term benefit to our primary outcomes. Programme continuation is not justified on the basis of available evidence, but could be reconsidered should supportive longer-term evidence emerge.FundingDepartment of Health Policy Research Programme.

Project description:Implementation fidelity is a key issue in home-visiting programs as it determines a program's effectiveness in accomplishing its original goals. This paper seeks to evaluate fidelity in a 27-month program addressing maternal and child health which took place in France between 2006 and 2011.To evaluate implementation fidelity, home visit case notes were analyzed using thematic qualitative and computer-assisted linguistic analyses.During the prenatal period, home visitors focused on the social components of the program. Visitors discussed the physical changes in pregnancy, and psychological and social environment issues. Discussing immigration, unstable employment and financial related issues, family relationships and dynamics and maternity services, while not expected, were found in case notes. Conversely, health during pregnancy, early child development and postpartum mood changes were not identified as topics within the prenatal case notes. During the postnatal period, most components of the intervention were addressed: home visitors observed the mother's adaptation to the baby; routine themes such as psychological needs and medical-social networks were evaluated; information on the importance of social support and on adapting the home environment was given; home visitors counseled on parental authority, and addressed mothers' self-esteem issues; finally, they helped to find child care, when necessary. Some themes were not addressed or partially addressed: health education, child development, home environment, mother's education plans and personal routine, partner support and play with the child. Other themes were not expected, but found in the case notes: social issues, mother-family relationship, relation with services, couple issues, quality of maternal behavior and child's language development.In this program, home visitors experienced difficulties addressing some of the objectives because they gave precedence to the families' urgent needs. This research stresses the importance of training home visitors to adapt the intervention to the social, psychological and health needs of families.

Project description:BACKGROUND:Specialist parenting intervention could improve coexistent parenting and child mental health difficulties of parents affected by severe personality difficulties. OBJECTIVE:Conduct a feasibility trial of Helping Families Programme-Modified (HFP-M), a specialist parenting intervention. DESIGN:Pragmatic, mixed-methods trial, 1:1 random allocation, assessing feasibility, intervention acceptability and outcome estimates. SETTINGS:Two National Health Service health trusts and local authority children's social care. PARTICIPANTS:Parents: (i) primary caregiver, (ii) 18 to 65 years, (iii) severe personality difficulties, (iv) proficient English and (v) capacity for consent. Child: (i) 3 to 11 years, (ii) living with index parent and (iii) significant emotional/behavioural difficulties. INTERVENTION:HFP-M: 16-session home-based intervention using parenting and therapeutic engagement strategies. Usual care: standard care augmented by single psychoeducational parenting session. OUTCOMES:Primary feasibility outcome: participant retention rate. SECONDARY OUTCOMES:(i) rates of recruitment, eligibility and data completion, and (ii) rates of intervention acceptance, completion and alliance (Working Alliance Inventory-Short Revised). Primary clinical outcome: child behaviour (Eyberg Child Behaviour Inventory). SECONDARY OUTCOMES:child mental health (Concerns About My Child, Child Behaviour Checklist-Internalising Scale), parenting (Arnold-O'Leary Parenting Scale, Kansas Parental Satisfaction Scale) and parent mental health (Symptom-Checklist-27). Quantitative data were collected blind to allocation. RESULTS:Findings broadly supported non-diagnostic selection criterion. Of 48 participants recruited, 32 completed post-intervention measures at mean 42 weeks later. Participant retention exceeded a priori rate (HFP-M=18; Usual care=14; 66.7%, 95%?CI 51.6% to 79.6%). HFP-M was acceptable, with delivery longer than planned. Usual care had lower alliance rating. Child and parenting outcome effects detected across trial arms with potential HFP-M advantage (effect size range: 0.0 to 1.3). CONCLUSION:HFP-M is an acceptable and potentially effective specialist parenting intervention. A definitive trial is feasible, subject to consideration of recruitment and retention methods, intervention efficiency and comparator condition. Caution is required in interpretation of results due to reduced sample size. No serious adverse events reported. TRIAL REGISTRATION NUMBER:ISRCTN14573230.

Dataset Information

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.

Publications

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.

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