Clinical trial NCT05542251: Education Program for Caregivers of Children With Gross Motor Delays
Official title: Three for the Under Three
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gross Motor Development Delay
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Child Development Understanding Score
timeFrame: Baseline, Week 9 (post-intervention)
measure: Change in Child Development Goals
timeFrame: Baseline, Week 9 (post-intervention)
measure: Change in Developmental Assessment of Young Children - Second Edition (DAYC-2) Gross Motor Subdomain Score
timeFrame: Baseline, Week 9 (post-intervention)
Secondary outcomes:
measure: Change in Parenting Stress Index, Fourth Edition Short Form (PSI-4-SF) Score
timeFrame: Baseline, Week 9 (post-intervention)
measure: Change in Mother-to-Infant Bonding Scale (MIBS) Score
timeFrame: Baseline, Week 9 (post-intervention)
measure: Change in Perceived Maternal Parenting Self-Efficacy (PMP S-E) Score
timeFrame: Baseline, Week 9 (post-intervention)
measure: Change in Satisfaction with Learning Content
timeFrame: Up to Week 9
measure: Satisfaction with the Intervention
timeFrame: Week 9 (post-intervention)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Emory Healthcare System
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Nathalie Maitre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: