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Clinical Trials/NCT05542251
NCT05542251
Completed
N/A

Three for the Under Three

Emory University3 sites in 1 country92 target enrollmentSeptember 28, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Gross Motor Development Delay
Sponsor
Emory University
Enrollment
92
Locations
3
Primary Endpoint
Change in Child Development Understanding Score
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 28, 2022
End Date
November 2, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nathalie Maitre

Professor

Emory University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Non-English-speaking

Outcomes

Primary Outcomes

Change in Child Development Understanding Score

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (3)

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