Building Community Health Volunteers' Capacity to Support Parents With Young Children With SafeCare Kenya

Официальное название

Implementing the Adapted Parenting Program, SafeCare Kenya, to Reduce Noncommunicable Disease Burden: Building Community Health Volunteers' Capacity to Support Parents With Young Children

Обзор

The goal of this clinical trial is to implement and examine the impact of SafeCare Kenya, an adapted parenting program, to improve parents' skills and knowledge related to the care of their children between the ages of 18 months and 5 years old. The main questions it aims to answer are: * Will SafeCare Kenya improve child and parent outcomes? * Is virtual delivery as effective as in-person delivery of SafeCare Kenya? * Is SafeCare Kenya feasible to deliver by community health volunteers? Mothers will: * Complete study assessments at three timepoints: baseline, 6 months and 18 months * Mothers in the SafeCare Kenya group will receive the program from their community health volunteer Researchers will compare SafeCare Kenya to care as usual by community health volunteers to see if SafeCare Kenya families show improvements in parent interaction skills, safety and health knowledge, potential for child abuse, child behavior problems, child injuries, parenting stress, and child and parent quality of life.

Подробное описание

After being informed about the study and potential risks, all community health volunteers consented to the study will be randomized to continue their usual services with families or be trained to deliver SafeCare Kenya to add to their usual services with families. All community health volunteers will inform their eligible families about the study and share with the research team mothers who express interest in the study. After being informed about the study and potential risks, all mothers giving informed consent will complete a baseline assessment, along with a 6 month and 18 month follow up assessment. Mothers whose community health volunteer is assigned to the SafeCare Kenya program will receive the program from their community health volunteers. All SafeCare Kenya mothers will be randomized to receive the program either in-person or virtually. Trainers and Stakeholders will provide information about their involvement in the project.

Вмешательства

• Поведенческое SafeCare Kenya
  Adapted from SafeCare, this is a strengths-based program for parents with children ages 18 months through age 5, teaching parents skills and knowledge in three areas: 1) parent-child interactions, 2) child health, and 3) home safety.
• Другое Care as Usual by Community Health Volunteers
  Community Health Volunteers support families with children up to age 5 around the physical health needs of family members, including delivering key health messages (e.g., importance of immunizations); treating minor injuries and illnesses; identifying/treating/referring common childhood illnesses (e.g., diarrhea, malaria); conducting home visits to evaluate the home environment and discuss improvements; and encouraging care at home and appropriate health seeking behaviors. These support services

Первичные конечные точки

• Change from Baseline in score on Child Planned Activities Training (cPAT) at 6 months [Срок оценки: Baseline and 6 months]
• Change from Baseline in score on Child Planned Activities Training (cPAT) at 18 months [Срок оценки: Baseline and 18 months]
• Change from Baseline in scores on Parenting Young Children (PARYC) at 6 months [Срок оценки: Baseline and 6 months]
• Change from Baseline in scores on Parenting Young Children (PARYC) at 18 months [Срок оценки: Baseline and 18 months]
• Change from Baseline in score on How to Keep your Child Safe and Healthy Quiz at 6 months [Срок оценки: Baseline and 6 months]
• Change from Baseline in score on How to Keep your Child Safe and Healthy Quiz at 18 months [Срок оценки: Baseline and 18 months]
• Change from Baseline in score on Brief Child Abuse Potential Inventory (BCAPI) at 6 months [Срок оценки: Baseline and 6 months]
• Change from Baseline in score on Brief Child Abuse Potential Inventory (BCAPI) at 18 months [Срок оценки: Baseline and 18 months]

Вторичные конечные точки (10)

• Change from Baseline in score on Child Behavior Checklist (CBCL) at 6 months [Срок оценки: Baseline and 6 months]
• Change from Baseline in score on Child Behavior Checklist (CBCL) at 18 months [Срок оценки: Baseline and 18 months]
• Change from Baseline in scores on Parenting Stress Index at 6 months [Срок оценки: Baseline and 6 months]
• Change from Baseline in scores on Parenting Stress Index at 18 months [Срок оценки: Baseline and 18 months]
• Change from Baseline in score on Childhood injuries at 6 months [Срок оценки: Baseline and 6 months]
• Change from Baseline in score on Childhood injuries at 18 months [Срок оценки: Baseline and 18 months]
• Change from Baseline in score on Child Quality of Life at 6 months [Срок оценки: Baseline and 6 months]
• Change from Baseline in score on Child Quality of Life at 18 months [Срок оценки: Baseline and 18 months]
• Change from Baseline in score on Parent Quality of Life at 6 months [Срок оценки: Baseline and 6 months]
• Change from Baseline in score on Parent Quality of Life at 18 months [Срок оценки: Baseline and 18 months]

Критерии участия

Parents Inclusion Criteria:

• being the female primary caregiver
• at least 18 years old of age
• at least one child between 18 months and age 5
• reside in Kibera
• have ability to participate virtually (i.e., owns a smart phone) in English or Swahili.

Parent Exclusion Criteria:

• younger than 18 years old
• unable to participate in English or Swahili
• does not own smart phone to participate in virtual sessions.

CHV Inclusion Criteria:

• 18 years or older
• able to participate in English or Swahili
• has ability to participate virtually (i.e., owns a smart phone)
• female community health volunteer who is affiliated with one of the project's agencies in Kibera

CHV Exclusion Criteria:

• younger than 18 years old
• not able to participate in English or Swahili
• does not have a smart phone
• is not female
• is not a community health volunteer affiliated with one of the project's agencies

Trainer Inclusion Criteria:

• 18 years or older
• able to participate in English and Swahili
• trained as a SafeCare trainer

Trainer Exclusion Criteria:

• younger than 18 years old
• not able to participate in English and Swahili
• not trained as a SafeCare Trainer

Stakeholder Inclusion Criteria:

• 18 years or older
• able to participate in English
• involved in the project as a stakeholder

Stakeholder Exclusion Criteria:

• younger than 18 years old
• not able to participate in English
• not a stakeholder for this project

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Kenya · 1 центр

• Africa Institute of Mental and Brain Health — Nairobi

Идентификаторы

NCT: NCT06363695 · 131-22 · 1R01HD112043-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗