- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07712822
Integrating Evidence-based Approaches to Prevent Child Maltreatment in Kyrgyzstan
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Associate Professor, PhD
- Telefonní číslo: 608-422-9771
- E-mail: saltanat.childress@uta.edu
Studijní místa
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Bishkek, Kyrgyzstán
- Nábor
- Republican Institute for Advanced Studies and Teacher Training under the Ministry of Education of the Kyrgyz Republic
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Kontakt:
- Curriculum Specialist
- Telefonní číslo: +996 (556) 600-324
- E-mail: teachertraining.kg@gmail.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Experimental
The integrated prevention program is designed for families with children ages 6-9 to strengthen parenting, improve co-parenting relationships, reduce family conflict, and address financial stress linked to child maltreatment risk. Program topics include family communication, stress management, respectful conflict resolution, positive parenting, child self-regulation, and financial literacy and asset building. The intervention is delivered in school settings through 16 weekly group sessions that include skill-building exercises, guided discussions, and role-plays. The economic component includes workshops on savings, future planning, and income-generating strategies. The program is delivered by trained school social workers who receive structured training and supervision to support fidelity. |
This intervention uniquely integrates three evidence-based approaches (strengthening families, coparenting and father involvement, and economic empowerment) into a single coordinated prevention model.
Unlike stand-alone parenting or couples programs, it simultaneously targets family processes (communication, co-parenting, stress regulation), child self-regulation and school adaptation, and structural economic stressors through asset-building and financial literacy components.
The program is culturally adapted for Kyrgyzstani families using stakeholder-guided methods and delivered within school settings by trained social pedagogues.
The integration of behavioral family intervention with economic strengthening distinguishes it from traditional parenting-only or school-only prevention programs.
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Žádný zásah: Bolstered Standard of Care
No Intervention (Bolstered Standard of Care) is designed to reflect usual school services available to families while providing minimal material support to promote retention and ethical balance. Schools in Kyrgyzstan do not routinely offer structured family-based behavioral interventions. Participants in this arm will receive standard educational services provided by their school, supplemented with school supplies (e.g., notebooks). Families in this arm will complete the same assessment schedule as the intervention group at baseline, immediately post-intervention (16 weeks), and end-of-school-year follow-up. No structured strengthening families, co-parenting, or economic empowerment sessions are provided in this condition. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Strengths and Difficulties Questionnaire (SDQ) Parent Report
Časové okno: Up to 1.5 years after baseline
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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.
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Up to 1.5 years after baseline
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Strengths and Difficulties Questionnaire (SDQ) Self-Report (Youth version)
Časové okno: Baseline through 1.5 years after baseline
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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.
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Baseline through 1.5 years after baseline
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Strengths and Difficulties Questionnaire (SDQ) Teacher Report
Časové okno: Up to 1.5 years after baseline
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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.
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Up to 1.5 years after baseline
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 2022-0605
- K01HD106070 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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