Gross Motor Development DelayNCT05542251
Education Program for Caregivers of Children With Gross Motor Delays
A study testing Parent Educational Program in people with Gross Motor Development Delay, run by Emory University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gross Motor Development Delay
- What is being tested?
- Parent Educational Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Sep 2022to 2 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non-English-speaking
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Emory Healthcare System
Atlanta, Georgia, 30322
Emory University
Atlanta, Georgia, 30322
About this study
Official title: Three for the Under Three
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.
Read the 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.
- Conditions
- Gross Motor Development Delay
- Being tested
- Parent Educational Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Educational ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Parent Educational Program | Experimental | Caregivers of children with gross motor delays who are randomized to receive an educational intervention delivered through social media. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 9 (post-intervention)
Secondary outcomes (5)
Change in Parenting Stress Index, Fourth Edition Short Form (PSI-4-SF) Score
To assess parental stress, the PSI-4-SF yields scores on the following subscales: 1) Parental Distress, 2) Parent-Child Dysfunctional Interaction, and 3) Difficult Child. The instrument has 36 items which are responded to on a 5-point scale ranging from Strongly Agree to Strongly Disagree. A Total Stress Score is obtained by combining the subscales. The software to score the PSI-4-SF provides a percentile score. Percentile scores between 16 and 84% are considered normal stress, while scores of 85-89% indicate high stress and scores of 90% or higher indicate stress levels that may be clinically significant.
Measured: Baseline, Week 9 (post-intervention)
Change in Mother-to-Infant Bonding Scale (MIBS) Score
The Mother-to-Infant Bonding Scale (MIBS) is an 8-item questionnaire in which the mother/caregiver self-reports her feelings towards her baby. Responses are given on a 4-point scale where 0 = not at all and 3 = very much. Total scores range from 0 to 24 and some items are reversed scored so that higher scores indicate worse bonding between mother and infant.
Measured: Baseline, Week 9 (post-intervention)
Change in Perceived Maternal Parenting Self-Efficacy (PMP S-E) Score
Attitude towards parenting is measured using the Perceived Maternal Parenting Self-Efficacy (PMP S-E) instrument. The PMP S-E is a 20-item Likert scale survey asking parents to rate personal importance/value of parenting and confidence in parenting choices. Responses are given on a 4-point scale where 1 = strongly disagree and 4 = strongly agree. Total scores range from 20 to 80 and higher scores indicate greater parenting self-efficacy.
Measured: Baseline, Week 9 (post-intervention)
Change in Satisfaction with Learning Content
Parent satisfaction with the program will be assessed with weekly surveys asking participants to respond to 15 statements to measure how well they liked the content and delivery method of the educational modules. Responses are given on a 5-point scale where 1 = strongly disagree and 5 = strongly agree. Total scores range from 15 to 75, where higher scores indicate greater satisfaction with the learning content.
Measured: Up to Week 9
Satisfaction with the Intervention
Parent satisfaction with the program will be assessed qualitatively through facilitated discussions at the conclusion of the intervention period. This assessment of satisfaction is not measured quantitatively and a score is not calculated.
Measured: Week 9 (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start28 Sep 2022
- Primary completion2 Nov 2023
- Study completion2 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gross Motor Development DelayStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathalie Maitre, Emory University
- Investigators
- Nathalie Maitre, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542251
- Sponsor's protocol ID
- STUDY00004252
- Status last verified
- Feb 2024
- First submitted
- 13 Sep 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 2026 Feb;99(2):693-702. doi: 10.1038/s41390-025-04151-5. Epub 2025 Jun 12.
PubMed 40506582
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three for the Under Three
- ClinicalTrials.gov ID
- NCT05542251
- Acronym / sponsor ID
- STUDY00004252
- Conditions
- Gross Motor Development Delay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent Educational Program | Experimental | Behavioral: Parent Educational ProgramCaregivers of children with gross motor delays who are randomized to receive an educational intervention delivered through social media. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Non-English-speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent Educational ProgramThe 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. | Behavioural | Parent Educational Program |
Primary outcome
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.
5 secondary outcomes
Change in Parenting Stress Index, Fourth Edition Short Form (PSI-4-SF) Score
Time frame: Baseline, Week 9 (post-intervention)
Change in Mother-to-Infant Bonding Scale (MIBS) Score
Time frame: Baseline, Week 9 (post-intervention)
Change in Perceived Maternal Parenting Self-Efficacy (PMP S-E) Score
Time frame: Baseline, Week 9 (post-intervention)
Change in Satisfaction with Learning Content
Time frame: Up to Week 9
Satisfaction with the Intervention
Time frame: Week 9 (post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 40506582Maitre 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. 2026 Feb;99(2):693-702. doi: 10.1038/s41390-025-04151-5. Epub 2025 Jun 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie Maitre, MD, PhD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Educational Program in people with Gross Motor Development Delay, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Child Development Understanding Score (time frame: Baseline, Week 9 (post-intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05542251, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.