Cluster-Randomized Controlled Trial of a Father-Inclusive Parenting Intervention in Mwanza, Tanzania
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 792
- 试验地点
- 3
- 主要终点
- Parental stimulation score
研究概览
简要总结
This cluster-randomized controlled trial aims to evaluate the impact of a couples-based parenting program, "Familia Bora," on mothers' and fathers' parenting, couples' relationships, gender, and early child development in the Mwanza Region, Tanzania. Additionally, this study aims to assess the program's implementation and identify factors influencing its quality and effectiveness.
Trained community health workers will deliver the program by facilitating weekly peer group sessions in their villages. Twelve couples with a child under two years old will be enrolled in each village. The program will cover various topics, including responsive caregiving, positive discipline, stress management, healthy couples' communication, nutrition, and gender.
详细描述
An estimated 43% of children under five in low- and middle-income countries are at risk of not achieving their developmental potential, with the burden highest in sub-Saharan Africa. While there is robust evidence on the effectiveness of parenting interventions for improving nurturing care and early childhood development (ECD), the vast majority of existing programs have targeted mothers exclusively. Fathers are often excluded from parenting programs, even though evidence highlights their vital contributions to child and family wellbeing.
This cluster-randomized controlled trial will evaluate the impacts and implementation quality of a newly developed, culturally-responsive, gender-transformative, and father-inclusive parenting intervention ("Familia Bora"). The study will be implemented in 33 villages across Misungwi and Sengerema districts in Mwanza Region, Tanzania. Half of the villages will be randomly assigned to the intervention (17 villages) versus control group (16 villages) with stratification by district. The program will train community health workers (CHWs) to deliver the program to groups of 12 randomly selected couples per village.
Familia Bora primarily involves group sessions covering various topics, including responsive parenting, positive discipline, couples' communication, stress management, and gender roles in family caregiving. These group sessions will be held at a convenient community location on a weekly basis for approximately five months.
In total, the trial will enroll 396 couples with young children (i.e., 396 men and 396 female partners). Quantitative surveys will be conducted with fathers and mothers at baseline and endline to assess outcomes, including maternal and paternal parenting practices and attitudes, gender attitudes, relationship dynamics, and early childhood development. Quantitative data will be collected from CHWs at baseline and endline to assess program-related changes in their knowledge, attitudes, and skills. In addition to the quantitative evaluation, qualitative methods will be used to evaluate implementation processes and participant perspectives through midline and endline in-depth interviews with a subsample of caregivers and CHWs, community leaders, and other relevant stakeholders across the intervention villages. The primary endpoint for the trial will be the endline assessment, or 6 months post-baseline.
Following completion of the core Familia Bora program, intervention villages will be re-randomized (stratified by district) to receive either a 3-month booster extension or no additional intervention. The booster will consist of monthly group session and home visits focused particularly on reinforcing responsive caregiving and early learning. A secondary follow-up assessment will be conducted at 12 months post-baseline to evaluate the effects of the booster component and sustainability of intervention impacts on the short-term.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligibility criteria for couples:
- •Inclusion Criteria:
- •Each individual is an adult aged 18-65 years
- •Each individual is the primary female or male caregiver of a child younger than 2 years of age
- •The two individuals are currently in a marital or partnered relationship with each other
- •Both individuals have lived in the same household as each other and the child during the past month, and
- •Both individuals provide written informed consent to participate in the study.
排除标准
- •Need to satisfy the inclusion criteria
研究组 & 干预措施
Familia Bora
Participants will be offered a parenting group program available in their community, with weekly scheduled sessions for approximately 5 months.
干预措施: Familia Bora (Behavioral)
Control Group
Participants will not receive any intervention.
结局指标
主要结局
Parental stimulation score
时间窗: Baseline, 6 months
Maternal and paternal stimulation practices will be measured by the Family Care Indicators (FCI), which are reported in terms of the number of developmentally-enriching activities that the parent engaged with the young child in the past week (e.g., singing, telling stories). Activities adapted from the Family Care Indicators. The total score ranges from 0 to 7, with higher scores indicating greater parental engagement in stimulation activities.
Parental stimulation score
时间窗: Baseline, 6 months (primary endpoint), 12 months (secondary follow-up)
Maternal and paternal stimulation practices will be measured by the Family Care Indicators (FCI), which are reported in terms of the number of developmentally-enriching activities that the parent engaged with the young child in the past week (e.g., singing, telling stories). Activities adapted from the Family Care Indicators. The total score ranges from 0 to 7, with higher scores indicating greater parental engagement in stimulation activities.
次要结局
- Caregiver Reported Early Development Instrument (CREDI) long form(Baseline, 6 months, 12 months)
- Variety of early learning materials score(Baseline, 6 months, 12 months)
- Parental disciplinary practices score(Baseline, 6 months, 12 months)
- Level of father involvement in childcare and household chores(Baseline, 6 months, 12 months)
- Parenting attitudes score(Baseline, 6 months, 12 months)
- Gender attitudes score(Baseline, 6 months, 12 months)
- Decision-making score(Baseline, 6 months, 12 months)
- Parenting stress score(Baseline, 6 months, 12 months)
- Maternal intimate partner violence victimization(Baseline, 6 months, 12 months)
- Child dietary diversity(Baseline, 6 months, 12 months)
- Caregiver Reported Early Development Instrument (CREDI) long form(Baseline, 6 months)
- Variety of early learning materials score(Baseline, 6 months)
- Parental disciplinary practices score(Baseline, 6 months)
- Level of father involvement in childcare and household chores(Baseline, 6 months)
- Parenting attitudes score(Baseline, 6 months)
- Gender attitudes score(Baseline, 6 months)
- Decision-making score(Baseline, 6 months)
- Parenting stress score(Baseline, 6 months)
- Maternal intimate partner violence victimization(Baseline, 6 months)
- Child dietary diversity(Baseline, 6 months)
研究者
Joshua Jeong
Assistant Professor
Emory University
