跳至主要内容
临床试验/NCT05770414
NCT05770414招募中不适用

Can We Still Make the Connection? Evaluating an Online Parenting Intervention for Caregivers of Infants and Young Children

University of Ottawa2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年6月8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
200
试验地点
2
主要终点
Caregiver-child bond will be measured using the Maternal Postnatal Attachment Scale (MPAS)

研究概览

简要总结

The goal of this clinical trial is to evaluate the effectiveness of the online modality of the Make the Connection (MTC) program in caregivers of infants and young children. The main questions it aims to answer are:

  • Does the MTC online program result in changes in the child-caregiver relationship, caregiver self-competence, caregiver stress, caregiver depression, as well as caregiver and child emotion regulation, as compared to a waitlist control?
  • Are caregivers who experience psychosocial risks (e.g., elevated depression scores, social isolation) deriving similar benefits in the child-caregiver relationship, caregiver self-competence, caregiver stress, caregiver depression, as well as caregiver and child emotion regulation as caregivers who are not?
  • What are some of the barriers, facilitators, perceived benefits, and risks to participating in the MTC online program from the perspective of caregivers?

Participants will be randomly placed into either the intervention group or the waitlist control group. Both groups will be asked to complete a pre-intervention questionnaire, the intervention group will be invited to complete the 8-week MTC online program consisting of a weekly 15-minute module, and both groups will lastly be asked to complete a post-intervention questionnaire.

Researchers will compare the intervention group and the waitlist control group to see if the MTC online program results in improved caregiver-child bond, caregiver self-efficacy, caregiver stress, and caregiver depression.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • caregivers with children between the ages of 0-3 years old
  • caregivers are primarily responsible for the children
  • caregivers are over 18 years of age
  • caregivers are able to complete the questionnaires and understand the program content in English

排除标准

  • 未提供

结局指标

主要结局

Caregiver-child bond will be measured using the Maternal Postnatal Attachment Scale (MPAS)

时间窗: Change from pre-intervention scores at baseline and post-intervention scores at week 8

The MPAS is a 19-item questionnaire that assesses caregivers' relational attitudes towards their infant. There are three main subscales derived from the measure: Quality of Attachment, Pleasure in Interaction, and Absence of Hostility. The MPAS has shown strong psychometric properties for use in community samples and can be used with mothers and fathers. The minimum score is 19 while the maximum score is 95. Lower scores indicate more problematic responses and there is no cut off points for problematic or concerning relationships.

次要结局

  • Caregivers' stress will be measured using the Parenting Stress Scale (PSS)(Change from pre-intervention scores at baseline and post-intervention scores at week 8)
  • Infant emotion regulation will be assessed using two items from the Ages & stages questionnaire: Social-Emotional, Second Edition (ASQ-SE)(Change from pre-intervention scores at baseline and post-intervention scores at week 8)
  • Caregivers' depression will be measured using the Centre for Epidemiological Studies Depression Scale (CES-D)(Change from pre-intervention scores at baseline and post-intervention scores at week 8)
  • Caregivers' self-efficacy will be measured using the Parent Sense of Competence Questionnaire (PSOC)(Change from pre-intervention scores at baseline and post-intervention scores at week 8)
  • Caregivers' emotion regulation will be assessed using three items from the Difficulties in Emotion Regulation Scale (DERS)(Change from pre-intervention scores at baseline and post-intervention scores at week 8)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验