このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Familia Imara: A Parenting Program to Reduce Family Violence in Tanzania

2026年6月3日 更新者:Saini Das

Cluster Randomized Controlled Trial to Assess the Effectiveness of Familia Imara in Preventing Violence Against Women and Children and Improving Child Nutrition and Development in Tanzania

This cluster-randomized controlled trial will evaluate the effectiveness, implementation, and scalability of Familia Imara, a group-based, couples-focused, community health worker (CHW)-delivered parenting program, on reducing intimate partner violence (IPV), harsh discipline, and improving child development and nutrition outcomes in the Mara and Geita regions of Tanzania. Villages will be randomly assigned to either an intervention or control arm. The study will be implemented in two sequential cohorts. In Cohort 1, a traditional randomized controlled trial will compare intervention villages receiving the program to control villages receiving no intervention (waitlist control), with delivery supported primarily by implementing partners in collaboration with government supervisors. In Cohort 2, the same villages will retain their original assignment. Intervention villages will receive the program under a government-led delivery model to assess scalability and integration into existing systems, while control villages will transition from waitlist to receive the intervention. Evidence generated will inform policy and practice for preventing family violence and promoting early childhood development at scale.

調査の概要

詳細な説明

IPV is a major global public health concern affecting millions of women worldwide, with caregivers of young children particularly vulnerable. IPV undermines women's health and wellbeing and disrupts caregiving environments, parenting practices, and early child development. While parenting interventions have demonstrated benefits for child outcome, few explicitly integrate violence prevention and gender-transformative components. This study is a cluster-randomized controlled trial designed to generate rigorous evidence on the effectiveness, implementation, and scalability of Familia Imara, a couples-focused, group-based parenting intervention that integrates nurturing care content with gender-transformative and violence prevention approaches and is delivered by CHWs.

The study will be conducted in the Mara and Geita regions of Tanzania using a multi-stage sampling strategy, including ward, village, and household selection. Villages will be randomly assigned to either the intervention or control arm. In each village, approximately 14 couples with a child under two years of age will be enrolled per cohort.

The trial will be implemented in two sequential cohorts to assess both effectiveness and pathways to scale. In Cohort 1, intervention villages will receive the Familia Imara program delivered by trained CHWs. Training, mentorship, and supervision of CHWs will be led primarily by implementing partners, in collaboration with government supervisors. Control villages will serve as a waitlist comparison group and will not receive the intervention during this phase. In Cohort 2, the same villages will retain their original study arm assignment. In intervention villages, the same CHWs will deliver the program to newly formed groups of eligible caregivers. During this phase, re-training, mentorship, and supervision will be led primarily by government supervisors, with reduced involvement from implementing partners, to assess the feasibility of scale-up and integration into existing government systems. In control villages, the waitlist control condition will end, and CHWs from these villages will be newly trained to deliver the intervention. Program delivery in these villages will follow a model similar to Cohort 1, with joint involvement of implementing partners and government supervisors.

The Familia Imara program consists of group sessions delivered twice monthly over approximately 10 months, including a mixture of joint couples' sessions and separate peer group sessions for mothers and fathers. Core content includes responsive caregiving, play and communication, nutrition and infant and young child feeding, positive discipline, gender norms, non-violent conflict resolution, and prevention of IPV.

Cohort 1 will enroll approximately 2,072 couples (4,144 individuals), consisting of 2,072 mothers and 2,072 fathers who are partnered with each other. In Cohort 2, an additional 1,036 new couples (2,072 individuals) will be enrolled in the intervention villages that previously received the program. Quantitative surveys will be administered at baseline and follow-up time points to assess changes in outcomes within and between study arms over time, as well as differences across delivery models.

研究の種類

介入

入学 (推定)

6216

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

      • Dar es Salaam、タンザニア
        • 募集
        • National Institute for Medical Research (NIMR)
        • コンタクト:
        • 主任研究者:
          • Joshua Jeong
        • 副調査官:
          • Gerry Mshana

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

Inclusion Criteria:

  • The household has a child aged 0-24 months at enrollment
  • The child has a primary female caregiver (i.e., mother) and a primary male caregiver (i.e., father) who are in a partnered relationship
  • Primary female caregiver, primary male caregiver, and child reside together in the same household
  • Both caregivers provide written informed consent for themselves and their child to participate in the study

Exclusion Criteria:

  • Need to satisfy the inclusion criteria
  • Expecting to relocate in the next year

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:単一グループの割り当て
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:Familia Imara
Participants will be offered a parenting program delivered within their community, consisting of two sessions per month over approximately 10 months.
Familia Imara is a couples-based, group parenting program delivered by trained community health workers (CHWs) in community settings. In each village, one male and one female CHW are assigned to facilitate the program. They co-facilitate joint couples' sessions and lead separate peer group sessions for mothers and fathers in a gender-matched format. Sessions are approximately 2 hours in duration and occur twice monthly over a 10-month period. Curriculum content includes: prevention of IPV and harsh discipline, play and early learning stimulation, nutrition and infant and young child feeding practices, couples' communication and conflict resolution, stress management, power, and gender norms and roles.
介入なし:Waitlist Control Group
Participants will not receive any intervention in Cohort 1 and will serve as a comparison group.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Maternal intimate partner violence victimization
時間枠:Baseline, 11 months, 22 months
Mothers will report on their experiences of intimate partner violence in the past six months using a standardized set of violent acts perpetrated by their partner (i.e., the child's father), adapted from the World Health Organization's multi-country study on women's health and domestic violence against women. The primary IPV indicator will be a proportion reflecting the percentage of mothers who report experiencing any form of IPV. In addition, we will calculate separate binary indicators for each type of IPV (physical, sexual, and emotional).
Baseline, 11 months, 22 months
Child dietary diversity
時間枠:Baseline, 11 months, 22 months
Child dietary diversity will be reported by mothers as the number of food groups (out of eight) consumed by the child in the previous 24 hours, following World Health Organization (WHO) guidelines. This measure is assessed in children aged six months and older, with higher scores indicating a greater likelihood of achieving a nutritionally adequate diet.
Baseline, 11 months, 22 months
Parental harsh disciplinary practices
時間枠:Baseline, 11 months, 22 months
Parental disciplinary practices will be self-reported by both mothers and fathers in terms of harsh disciplinary practices (e.g., shook the child, shouted at the child) used by the parent towards the child in the past month. Items were adapted from the Child Discipline Module of the Multiple Indicator Cluster Survey. The primary indicator will be a proportion for mothers and fathers who used any harsh disciplinary practices, with separate indicators by type (physical, verbal).
Baseline, 11 months, 22 months
Caregiver Reported Early Development Instrument (CREDI) long form
時間枠:Baseline, 11 months, 22 months
Early child development will be measured using the Caregiver Reported Early Development Instrument (CREDI) long form. It relies on parental reporting and assesses four domains of early developmental milestones: motor, language, cognitive, and socioemotional development. Higher scores reflect a greater number of age-appropriate developmental skills as reported by caregivers.
Baseline, 11 months, 22 months

二次結果の測定

結果測定
メジャーの説明
時間枠
IPV attitudes
時間枠:Baseline, 11 months, 22 months
Attitudes toward intimate partner violence will be reported by mothers and fathers using a tool adapted from the Demographic and Health Surveys (DHS). The instrument assesses whether respondents believe a man is justified in hitting or beating his wife in specific situations. Items are measured using a Likert-type response scale (e.g., strongly agree to strongly disagree). Responses will be coded and summed to create a composite score, with higher scores indicating less accepting attitudes toward intimate partner violence.
Baseline, 11 months, 22 months
Knowledge of child nutrition and development
時間枠:Baseline, 11 months, 22 months
Knowledge of child nutrition and development will be reported by mothers and fathers using a structured questionnaire developed by the study team. The instrument includes items on developmental milestones, early learning and responsive caregiving, child nutrition, and infant and young child feeding practices. Respondents will answer a series of true/false and short-answer questions. Two separate indicators will be derived: (1) knowledge of child nutrition, and (2) knowledge of child development. Each indicator will be analyzed separately, with higher scores indicating greater knowledge in the respective domain.
Baseline, 11 months, 22 months
Parenting attitudes
時間枠:Baseline, 11 months, 22 months
Attitudes toward parenting will be reported by mothers and fathers using a tool developed by Jeong et al. in Tanzania. The tool captures agreement with statements related to developmentally appropriate parenting, general parenting practices, and discipline approaches. Higher scores reflect more positive attitudes toward parenting.
Baseline, 11 months, 22 months
Parental stimulation
時間枠:Baseline, 11 months, 22 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. Higher scores indicating greater parental engagement in stimulation activities.
Baseline, 11 months, 22 months
Couples' communication
時間枠:Baseline, 11 months, 22 months
The frequency of communication between partners will be reported by mothers and fathers using a tool developed by the study team. Respondents will rate how often they communicated about a range of topics (e.g., nutrition, child discipline, household finances) with their partner over the past week. Higher scores indicate more frequent communication between partners.
Baseline, 11 months, 22 months
Gender attitudes score
時間枠:Baseline, 11 months, 22 months
Gender attitudes reported by mothers and fathers regarding gender norms around childcare and domestic responsibilities, household equity, and power dynamics within partner relationships. This measure was developed by Jeong et al. in this context. Higher scores indicate more gender-equitable attitudes.
Baseline, 11 months, 22 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年5月2日

一次修了 (推定)

2027年5月1日

研究の完了 (推定)

2028年4月1日

試験登録日

最初に提出

2026年5月1日

QC基準を満たした最初の提出物

2026年5月1日

最初の投稿 (実際)

2026年5月8日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月4日

QC基準を満たした最後の更新が送信されました

2026年6月3日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する