Parent Informational Session for Child Development

Overseen By Lauren Woods, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Tennessee

Disqualifiers: Infant care by non-parent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to examine the impact of an educational intervention on infant motor skill development. The main question it aims to answer is: Question 1) Does exposure to an educational intervention on infant development positively impact infant motor skill development? Researchers will compare the intervention group to the treatment as usual group see if there are differences in infant motor skill development. The purpose of the proposed study is to determine if tummy time, play positions, screen time, and use of baby gear impacts early motor skill development in children. This is a Pilot study. A Pilot study is a small study that is carried out to collect information that will help in the planning of a larger study with the same topic.

Do I need to stop my current medications to participate?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Parent Informational Session, Parent Education, Infant Development Guidance?

Research shows that parent-focused education programs, like the COPE program, can significantly improve infant cognitive development and reduce parental stress, suggesting that similar educational interventions may benefit child development and parental coping. ^{1 2 3 4 5}

How does the Parent Informational Session treatment differ from other treatments for child development?

The Parent Informational Session treatment is unique because it focuses on educating parents about child development, enhancing their understanding and responsiveness to their child's needs, rather than directly treating the child. This approach empowers parents to actively engage in their child's development through knowledge transfer and practical activities, which is different from traditional medical or therapeutic interventions. ^{6 7 8 9 10}

Research Team

Anne H Zachry, PhD

Principal Investigator

University of Tennessee

Eligibility Criteria

This trial is for parents of newborns who speak and read English, have a baby 1 month old or younger born at least at 37 weeks with a birthweight over 5.5 pounds, without known health issues since birth. Parents must be over 18, live near the University of Tennessee Health Science Center, and have internet access plus video call capability.

Inclusion Criteria

My child has no health issues affecting their movement or development since birth.

Parent must own a cell phone with internet access and Zoom or Face Time capability

My baby is 1 month old or younger.

Exclusion Criteria

Infant is regularly cared for by an adult other than their parent for 20 hours or more per week

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Parents receive educational intervention on tummy time, play positions, screen time, and use of baby gear

6 months

1 informational session, optional Zoom consultation

Follow-up

Participants are monitored for changes in motor skill development using standardized questionnaires

6 months to 48 months

Treatment Details

Interventions

• Parent Informational Session

Trial Overview The study tests if teaching parents about infant development (like tummy time and limiting screen time) helps improve their baby's motor skills compared to usual care. It's a small pilot study meant to gather info for future research.

Participant Groups

Group I: Parent Informational Session Experimental Treatment 1 Intervention

Parental education session that includes information and a video on avoiding screen time in the first two years of life, the importance and benefits of infants being exposed to tummy time, varying play positions and limiting time in baby gear. Additional information will be provided on the importance of implementing tummy time during the first month of life as well as different ways to implement tummy time and how to increase infant tolerance to tummy time. Parents in the Parent Informational Session can request a Zoom consultation with the Principal Investigator if the parents have questions or need guidance with implementing tummy time.

Group II: Usual Care Group Receiving an Informational Tummy Time Brochure Active Control 1 Intervention

Usual care group will receive a brochure on the importance of tummy time and limiting baby gear.

Who Is Running the Clinical Trial?

University of Tennessee

Lead Sponsor

Trials

202

Recruited

146,000+

Findings from Research

The Parent's Circle program, attended by 104 parents in the NICU, significantly helped families feel supported and gain perspective on their situation, enhancing their interactions with their infants.

NICU staff observed that the knowledge parents gained from the program positively influenced their interactions and behaviors within the NICU, indicating a beneficial impact on the overall care environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a program to promote positive parenting in the neonatal intensive care unit. Pearson, J., Andersen, K.[2019]

Therapeutic patient education is a health improvement initiative that offers personalized support to children at risk of stroke and their families.

This approach relies on specially trained health professionals to share knowledge, behaviors, and attitudes necessary for effective care and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic education of children who are victims or at risk of a stroke]. Micaëlli, D.[2017]

A family-based asthma education program significantly improved the quality of life for both children with asthma and their parents, as shown in a study involving 34 families in each group over a 12-month period.

Children with non-allergic asthma in the experimental group demonstrated better pulmonary function, specifically in forced expiratory maneuvers, compared to the control group, highlighting the program's effectiveness in managing asthma symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Family Empowerment Education on Pulmonary Function and Quality of Life of Children With Asthma and Their Parents in Tunisia: A Randomized Controlled Trial. Dardouri, M., Sahli, J., Ajmi, T., et al.[2021]

The COPE intervention program significantly improved cognitive development in low-birth-weight premature infants, with COPE infants scoring 100.3 compared to 93.9 for comparison infants at 3 months, and a 14-point advantage at 6 months.

Mothers participating in the COPE program reported lower stress levels related to the NICU environment and had a better understanding of their infants' needs, suggesting that the program also positively impacted maternal coping.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving cognitive development of low-birth-weight premature infants with the COPE program: a pilot study of the benefit of early NICU intervention with mothers. Melnyk, BM., Alpert-Gillis, L., Feinstein, NF., et al.[2022]

A study involving 1628 children with atopic dermatitis showed that individualized nurse consultations significantly increased parents' self-confidence in managing their child's condition, with over 90% of parents finding the consultations supportive.

After 14 days, the consultations led to a notable reduction in the severity of symptoms, with only 20% of children experiencing severe symptoms and over 50% reporting decreased sleep disruption and itching.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved management of childhood atopic dermatitis after individually tailored nurse consultations: A pilot study. Rolinck-Werninghaus, C., Trentmann, M., Reich, A., et al.[2016]

A study developed 200 activity sheets for parents to engage with their children during health visits, covering various developmental areas and age groups, which were positively received by both parents and professionals.

Parents, especially those with less education, reported that the activities enhanced their understanding of child development and encouraged discussions with healthcare providers, although the study's preliminary nature limits broader conclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Denver developmental activities: a preliminary report. Frankenburg, WK., Thornton, SM.[2007]

The intervention program 'My Baby and Me' effectively improved parenting skills among at-risk mothers, leading to reduced controlling behaviors and increased positive interactions with their infants.

Mothers who participated in the program showed significant improvements in verbal support and teaching behaviors, indicating that training in parental responsiveness and developmental knowledge can enhance early parenting practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing parenting practices of at-risk mothers. Akai, CE., Guttentag, CL., Baggett, KM., et al.[2021]

Participation in a six-month home visitation program significantly increased new mothers' overall knowledge of child development, as measured by the KIDS inventory.

Both adolescent and older mothers showed similar improvements in their understanding of infant development, indicating that the program was effective across different age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge gained by mothers enrolled in a home visitation program. Hammond-Ratzlaff, A., Fulton, A.[2015]

A pilot study involving 25 mothers, 15 pediatricians, 12 pediatric residents, and 20 nurses identified differences in the informational priorities regarding postpartum discussions, highlighting a gap between what mothers and healthcare providers consider essential.

Observations of postpartum counseling sessions revealed that pediatricians' stated priorities often did not match the actual content of their discussions, suggesting a need for improved training in postpartum education for healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum education: a pilot study of pediatric and maternal perceptions. Greenberg, LW., Rice, HW., Rice, R.[2004]

A review of 44 websites on child development found that while the information is generally accurate, much of it is incomplete, unclear, or hard to navigate, which can hinder parents' ability to monitor their child's progress effectively.

There is a significant need for a comprehensive, user-friendly, and authoritative online resource for parents that includes clear illustrations and reliable data on child development to support their involvement in assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Is my child developing normally?': a critical review of web-based resources for parents. Williams, N., Mughal, S., Blair, M.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a program to promote positive parenting in the neonatal intensive care unit. [2019]

2. France pubmed.ncbi.nlm.nih.gov

[Therapeutic education of children who are victims or at risk of a stroke]. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of Family Empowerment Education on Pulmonary Function and Quality of Life of Children With Asthma and Their Parents in Tunisia: A Randomized Controlled Trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Improving cognitive development of low-birth-weight premature infants with the COPE program: a pilot study of the benefit of early NICU intervention with mothers. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Improved management of childhood atopic dermatitis after individually tailored nurse consultations: A pilot study. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Denver developmental activities: a preliminary report. [2007]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Enhancing parenting practices of at-risk mothers. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Knowledge gained by mothers enrolled in a home visitation program. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Postpartum education: a pilot study of pediatric and maternal perceptions. [2004]

10. England pubmed.ncbi.nlm.nih.gov

'Is my child developing normally?': a critical review of web-based resources for parents. [2019]