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临床试验/NCT07712822
NCT07712822招募中不适用

Integrating Evidence-based Approaches to Prevent Child Maltreatment in Kyrgyzstan

The University of Texas at Arlington1 个研究点 分布在 1 个国家目标入组 396 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
396
试验地点
1
主要终点
Strengths and Difficulties Questionnaire (SDQ) Parent Report

研究概览

简要总结

The goal of this clinical trial is to learn if a family-based prevention program works to prevent child maltreatment risk and other adverse childhood experiences (ACEs) among families in Kyrgyzstan. It will also learn about the safety, feasibility, and acceptability of the program. The main questions it aims to answer are: (1) Does the integrated family and economic empowerment program improve children's self-regulation, behavioral adjustment, and school adaptation? (2) Is the program feasible and acceptable for families and schools in Kyrgyzstan?

Researchers will compare the integrated prevention program to bolstered standard school services to see if the program improves child and family outcomes. Participants will: (a) Be randomly assigned to either the prevention program or bolstered standard school services; (b) Attend weekly group sessions for 16 weeks (if assigned to the prevention program); (c) Complete surveys at baseline, immediately after the 16-week program, and at the end of the school year; and (d) Provide information about child behavior, (co)parenting, family relationships, and financial well-being.

Results from this pilot study will inform a future larger trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
6 Years 至 74 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Two adult caregivers (≥18 years old) who identify as co-parents or primary caregivers of a target child
  • Target child aged 6-9 years enrolled in one of the participating schools in Bishkek, Kyrgyzstan
  • Both caregivers identify each other as family members responsible for the care of the child (e.g., parents, grandparents, or other adult caregivers)
  • Both caregivers report feeling safe participating together in a family-based program
  • Both caregivers are fluent in either Russian or Kyrgyz
  • Both caregivers are able and willing to provide informed consent
  • Child is able to provide assent and participate in age-appropriate assessments.
  • Family is willing to participate in study procedures, including random assignment and completion of assessments at baseline, post-intervention (16 weeks), and end-of-school-year follow-up.

排除标准

  • Report of severe physical or sexual intimate partner violence between caregivers within the past 12 months, as assessed during screening
  • Either caregiver is unable to provide informed consent
  • Either caregiver has a cognitive impairment or a severe mental health condition that would preclude participation in group sessions
  • Family plans to relocate outside the study area during the intervention period
  • Child has a severe developmental or medical condition that would prevent participation in assessments
  • Inability to communicate in Russian or Kyrgyz.

结局指标

主要结局

Strengths and Difficulties Questionnaire (SDQ) Parent Report

时间窗: Up to 1.5 years after baseline

Child behavioral and emotional adjustment will be assessed using the Strengths and Difficulties Questionnaire (SDQ) Parent Report, a 25-item caregiver-report measure assessing emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. Each item is scored on a 3-point scale (0-2). The Total Difficulties Score ranges from 0 to 40, with higher scores indicating greater behavioral and emotional difficulties (poorer adjustment). The Prosocial Behavior subscale ranges from 0 to 10, with higher scores indicating greater prosocial behavior.

Strengths and Difficulties Questionnaire (SDQ) Self-Report (Youth version)

时间窗: Baseline through 1.5 years after baseline

Child self-regulation will be assessed using the Strengths and Difficulties Questionnaire (SDQ) Self-Report (Youth Version), a 25-item self-report measure completed by children and adolescents that assesses emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. Each item is rated on a 3-point scale (0 = Not True, 1 = Somewhat True, 2 = Certainly True). The Total Difficulties Score ranges from 0 to 40, with higher scores indicating greater emotional and behavioral dysregulation (poorer self-regulation). The Prosocial Behavior subscale ranges from 0 to 10, with higher scores indicating greater prosocial behavior and social competence.

Strengths and Difficulties Questionnaire (SDQ) Teacher Report

时间窗: Up to 1.5 years after baseline

Child school adaptation will be assessed using the Strengths and Difficulties Questionnaire (SDQ) Teacher Report, a 25-item teacher-completed measure assessing emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. Items are rated on a 3-point scale (0 = Not True, 1 = Somewhat True, 2 = Certainly True). The Total Difficulties Score ranges from 0 to 40, with higher scores indicating greater emotional and behavioral difficulties (poorer functioning). The Prosocial Behavior subscale ranges from 0 to 10, with higher scores indicating greater prosocial behavior.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Saltanat

Associate Professor

The University of Texas at Arlington

研究点 (1)

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