Education Program for Caregivers of Children With Gross Motor Delays

NCT05542251 | Completed

• 1 other identifier: STUDY00004252
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 3

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.

Conditions

Gross Motor Development Delay

Outcome Measures

Primary Outcomes (3)

• Change in Child Development Understanding Score

  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.

  Baseline, Week 9 (post-intervention)

• Change in Child Development Goals

  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.

  Baseline, Week 9 (post-intervention)

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

  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.

  Baseline, Week 9 (post-intervention)

Secondary Outcomes (5)

• Change in Parenting Stress Index, Fourth Edition Short Form (PSI-4-SF) Score

  Baseline, Week 9 (post-intervention)

• Change in Mother-to-Infant Bonding Scale (MIBS) Score

  Baseline, 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

• Satisfaction with the Intervention

  Week 9 (post-intervention)

Study Arms (2)

Parent Educational Program

EXPERIMENTAL

Caregivers of children with gross motor delays who are randomized to receive an educational intervention delivered through social media.

Behavioral: Parent Educational Program

Control Group

NO INTERVENTION

Caregivers of children with gross motor delays who are randomized to the waitlist control group who will receive an educational intervention delivered through social media after a 9 week waiting period.

Interventions

Parent Educational Program BEHAVIORAL

The intervention is a series of 9 educational modules delivered via social media that will teach participants: 1) principles of infant learning, 2) principles of infant motor learning, and 3) principles of positive parenting.

Parent Educational Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-English-speaking

Sponsors & Collaborators

• Emory University: lead

Study Sites (3)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Emory Healthcare System

Atlanta, Georgia, 30322, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• Maitre NL, Marra L, Kjeldsen W, Pinson LJH, Byrne R, He Z, Murphy MM. A social media-delivered intervention for motor delays: stage-Ib randomized clinical trial and implementation exploration. Pediatr Res. 2025 Jun 12. doi: 10.1038/s41390-025-04151-5. Online ahead of print.

  PMID: 40506582 DERIVED

Study Officials

• Nathalie Maitre, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 15, 2022
• Study Start: September 28, 2022
• Primary Completion: November 2, 2023
• Study Completion: November 2, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)