跳至主要内容
临床试验/NCT05542251
NCT05542251已完成不适用

Three for the Under Three

Emory University6 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2022年9月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
6
主要终点
Change in Child Development Understanding Score

研究概览

简要总结

The main objective of this project is to determine whether an educational intervention delivered via social media can improve parent understanding of child development and progression in child's developmental goals. A secondary objective is to determine whether this intervention can improve parent-related outcomes, such as well-being, parent-child bonding, attitudes toward parenting, satisfaction with the educational program.

详细描述

Gross motor delays in childhood are common, though they vary in severity and outcome. Early detection and intervention are critical to promote best neurodevelopmental outcomes for these children; equally important is support for parents and/or caregivers of children with identified motor delays. Parent education programs for caregivers of children with gross motor delays have been shown to improve parent knowledge of motor development and decrease parental stress when offered in conjunction with physical therapy treatment, however, there is a lack of peer-reviewed evidence demonstrating the efficacy of educational interventions provided over a social media platform for the population targeted in this study.

Caregivers of children with gross motor delays will be randomized to receive an educational intervention delivered via social media over a 9 week period, or to receive the intervention after a 9 week waiting period.

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

  • Parent or legal guardian of child under 3 years with an identified motor delay
  • Access to device with high-speed internet to access Facebook
  • English speaking
  • Resides in the continental United States

排除标准

  • Non-English-speaking

结局指标

主要结局

Change in Child Development Understanding Score

时间窗: Baseline, Week 9 (post-intervention)

Parent understanding of child development will be measured using a 24-item questionnaire with true/false and multiple choice questions. Total scores range from 0 to 24 and higher scores indicate better understanding of child development.

Change in Child Development Goals

时间窗: Baseline, Week 9 (post-intervention)

Progression in specific developmental goals will be measured qualitatively by asking parents what their motor goals are for their child at the baseline assessment and asking what improvement have been made for those goals following completion of the intervention. A score is not calculated for this assessment.

Change in Developmental Assessment of Young Children - Second Edition (DAYC-2) Gross Motor Subdomain Score

时间窗: Baseline, Week 9 (post-intervention)

Progression in child's developmental goals are measured with administration of the Gross Motor Subdomain of the DAYC-2 instrument. Children are assessed on age appropriate gross motor skills and items receive a score of 1 if the child exhibits the skill or a score of 0 if the skill is not exhibited or is exhibited inconsistently. The number of items varies based on the age of the child. Raw scores are standardized and the standardized scores correspond with a descriptive term, where scores less than 70 = Very Poor, scores of 70-79 = Poor, scores of 80-89 = Below Average, scores of 90-110 = Average, scores of 111-120 = above average, scores of 121-130 = superior, and scores greater than 130 are Very Superior.

次要结局

  • Change in Mother-to-Infant Bonding Scale (MIBS) Score(Baseline, Week 9 (post-intervention))
  • Change in Parenting Stress Index, Fourth Edition Short Form (PSI-4-SF) Score(Baseline, Week 9 (post-intervention))
  • Satisfaction with the Intervention(Week 9 (post-intervention))
  • Change in Perceived Maternal Parenting Self-Efficacy (PMP S-E) Score(Baseline, Week 9 (post-intervention))
  • Change in Satisfaction with Learning Content(Up to Week 9)

研究者

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

Nathalie Maitre

Professor

Emory University

研究点 (6)

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