Parent Education for Developmental Delay

Overseen By Sarah E Fabrizi, PhD OTR/L

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Florida Gulf Coast University

Disqualifiers: Severe behavioral, sensory issues

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

Compensation: Varies

Number of Visits: 2

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help parents support their children’s development through play. It offers a program called "Promoting Playfulness," where parents of children aged 2 to 5, without major disabilities, can learn effective parenting tips during two online sessions. These sessions focus on child development, parent advocacy, and the benefits of play. Parents with a device, a stable internet connection, and the ability to speak high school-level English may be a good fit for this trial. As an Early Phase 1 trial, the study focuses on understanding how the program works in real-life settings, offering participants a chance to be among the first to benefit from these innovative parenting strategies.

Do I need to stop my current medications to join the trial?

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

What prior data suggests that this educational program is safe for parents and children?

Research has shown that playful parenting programs can positively impact child development. Although specific safety data for the "Promoting Playfulness" treatment in this trial is not available, similar educational and coaching programs are generally well-received. These programs typically teach parents how to support their child's growth through play.

Using play as a tool is generally safe because it builds on the natural way parents and children interact. Play is essential for child development, aiding in thinking, learning, physical skills, social skills, and emotional growth. Since this trial is in its early stages, it primarily aims to assess how well parents can follow the program and how it affects their interactions with their children.

Overall, the goal is to provide parents with knowledge and skills, which usually involves minimal risk. This approach enhances everyday activities, offering a safe and supportive way to help children thrive. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Promoting Playfulness" approach because it emphasizes play as a key driver for healthy child development, which is different from many standard treatments for developmental delays that often focus on direct therapy and structured interventions. This method involves educating parents through virtual training sessions, empowering them to become advocates for their child's development while reducing stressors. By equipping parents with knowledge and strategies to integrate play into daily life, this approach offers a more holistic and accessible way to support children compared to traditional methods.

What evidence suggests that this parent education program is effective for promoting child development?

Research has shown that playful parenting can greatly benefit a child's growth. One study found that more frequent playful interactions led to better development in children. When parents engage in play, it encourages their children to do the same, strengthening their bond. Reviews of parenting programs have also shown a positive impact on children's mental development, especially in lower-income countries. Play helps children think, socialize, and manage emotions, making it easier for them to handle stress. These findings suggest that encouraging playfulness in parenting can effectively support a child's development. In this trial, participants in the "Intervention - Parent Education" arm will engage in virtual training sessions focused on promoting playfulness to support healthy development. ^{2 4 5 6 7}

Who Is on the Research Team?

Sarah Fabrizi, PhD OTR/L

Principal Investigator

Associate Professor

AMiya Waldman-Levi, PhD OTR/L

Principal Investigator

Yeshiva University - Professor

Are You a Good Fit for This Trial?

This trial is for parents of children aged 2 to 5 years, both with and without disabilities. It aims to help those facing health inequalities, social isolation, or family adversity that could impact their child's development.

Inclusion Criteria

High school level English

Can commit to participating in two online sessions

Has a device with a stable internet connection

Exclusion Criteria

Parents with children who have severe behavioral or sensory issues

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Parents participate in 2 virtual training sessions focusing on child development and parent advocacy

2 weeks

2 virtual sessions

Follow-up

Participants complete questionnaires to assess program effectiveness and provide qualitative feedback

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Promoting Playfulness

Trial Overview The intervention being tested is a strength-based educational program designed to teach parents about promoting playfulness in children's activities. The goal is to empower parents as change agents for their child’s developmental progress.

How Is the Trial Designed?

Group I: Intervention - Parent Education Experimental Treatment 1 Intervention

Parents will participate in 2, 45 minute virtual training sessions with information and question and anwsers. Each session will provide information about child development and parent advocacy and stressors. Play as the means for promoting healthy development will be emphasized.

Group II: Waitlist control Active Control 1 Intervention

Parents will have family life as usual with no education sessions.

Who Is Running the Clinical Trial?

Florida Gulf Coast University

Lead Sponsor

Trials

14

Recruited

690+

Yeshiva University

Collaborator

Trials

13

Recruited

2,600+

Published Research Related to This Trial

This systematic review aims to gather evidence on how parents understand and experience play, particularly focusing on the differences between parents of children with disabilities and those with typically developing children.

By analyzing various studies, the review will highlight parents' awareness of the benefits of play for child development, which is crucial for facilitating effective play experiences, especially for children with disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parents' awareness, knowledge, and experiences of play and its benefits in child development: A systematic review protocol. Dhas, BN., Chacko, SM., David Solomon, VS., et al.[2022]

In a study of 20 children with motor delays, both mothers and fathers showed similar levels of motor behaviors and playfulness during play sessions, indicating that both parents can effectively engage with their children.

While mothers were generally more responsive, fathers spent more time holding their children on their laps, suggesting that each parent brings unique strengths to play interactions that can benefit the child's development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of motor behaviors, interaction, and playfulness during mother-child and father-child play with children with motor delay. Chiarello, LA., Huntington, A., Bundy, A.[2006]

A qualitative study involving caregivers of pediatric patients revealed that a game-based strategy effectively engaged parents in understanding and promoting patient safety actions.

The game not only facilitated knowledge transfer about patient safety but also positively changed caregivers' perceptions and behaviors, encouraging them to be more active participants in their child's care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ludic strategy for promoting engagement of parents and caregivers in the safety of pediatric patients. Gonçalves, KMM., Costa, MTTCA., Silva, DCB., et al.[2021]

Parents who received developmental education were more motivated to participate in home treatment programs for their developmentally delayed infants, leading to greater developmental gains for the children.

One year later, parents who had developmental education continued to be more involved in their child's treatment, suggesting that this approach fosters long-term engagement and helps parents recognize small developmental improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developmental education for parents of delayed infants: effects on parental motivation and children's development. Moxley-Haegert, L., Serbin, LA.[2006]

The study involved 18 researchers and 9 patient-partners who provided feedback on the patient engagement processes in developing a health coaching intervention, showing high agreement on the importance and impact of patient involvement.

Qualitative feedback indicated that while patient engagement significantly improved the project's quality and researchers' understanding, challenges included unrealistic deadlines for feedback and limited representation among patient-partners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient engagement in an online coaching intervention for parents of children with suspected developmental delays. Ogourtsova, T., O'Donnell, ME., Filliter, JH., et al.[2021]

A multi-centered randomized controlled trial will evaluate the effectiveness of the BRIGHT Coaching intervention for families of preschool-aged children with developmental delays, involving 392 families across four Canadian provinces.

The intervention aims to empower families by providing structured educational resources and support over 14 sessions, with outcomes measured for family empowerment and caregiver competency at baseline, 8 months, and 12 months post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BRIGHT Coaching: A Randomized Controlled Trial on the Effectiveness of a Developmental Coach System to Empower Families of Children With Emerging Developmental Delay. Majnemer, A., O'Donnell, M., Ogourtsova, T., et al.[2020]

A study involving 35 parent-child dyads over two years found that parents' responsive behaviors are closely linked to their children's engagement during play, suggesting that positive interactions can enhance child development.

Children who show more initiative in play may encourage parents to adopt more achievement-oriented and directive behaviors, indicating a potential cycle of mutual influence that could benefit developmental outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental behavior and child interactive engagement: a longitudinal study on children with a significant cognitive and motor developmental delay. Van Keer, I., Bodner, N., Ceulemans, E., et al.[2021]

The LEaP playgroup showed significant improvements in parenting distress and goal achievement for children with developmental delays after 8 weeks, with notable benefits continuing up to 28 weeks.

While LEaP did not show significant differences compared to the control group overall, it did lead to better outcomes in child performance and family support at both 12 and 28 weeks, suggesting it may be a helpful intervention for families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised Controlled Trial of a Therapeutic Playgroup for Children with Developmental Delays. Armstrong, J., Girdler, S., Davidson, E., et al.[2021]

In a study involving 60 parents of children with developmental delays, it was found that higher functional performance in these children is strongly correlated with better quality of life (QOL) for both the children and their parents.

The research indicates that as children's functional abilities improve, parents experience less emotional impact and better overall quality of life, highlighting the importance of supporting developmental progress in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlations between functional performance, health-related quality of life, and parental impact on children with developmental delays. Hsieh, RL., Lin, MI., Huang, HY., et al.[2018]

NeuroPLAY, an early intervention method for children with autism spectrum disorder (ASD), significantly improved the play skills of parents over a 12-month period, as indicated by increasing scores on the NeuroPLAY Parental Play Behavior Assessment Scale (NPPBAS).

Children's ASD symptoms, measured by the Childhood Autism Rating Scale (CARS), decreased after the intervention, demonstrating that NeuroPLAY not only benefits parental engagement but also positively impacts the children's symptoms, regardless of the parents' age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Play interactions of parents toward children with autism spectrum disorder: NeuroPLAY parent play behavior assessment scale. Gürkan Tazegül, EN., Kutlu Konuk, F., Aksu, ŞS., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11590245/

Effect of a playful parenting programme on early childhood ... The study demonstrated that higher intervention doses were associated with better child development outcomes in Nepal and only with medium dose in Uganda.

2. nature.com nature.com/articles/s41599-025-05253-5

Relation between parental playfulness and child playfulness Parental playfulness can significantly and positively predict the level of children's playfulness, and concurrently, parent-child interaction ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8109838/

Parenting interventions to promote early child development ... We conducted a global systematic review and meta-analysis to evaluate the effectiveness of parenting interventions on ECD and parenting outcomes.

4. mdpi.com mdpi.com/2227-9067/12/9/1241

Do Playful Parenting Programs Implemented at Scale ... Meta-analyses demonstrate that parenting programs in LMIC have a moderate effect size on children's mental development—stronger than effect sizes in HIC. The ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0149763418305116

The importance of play for the development of children in ... We argue that stimulating play behaviour enhances the adaptability of a child to a (chronic) stressful condition and promotes cognitive, social, emotional and ...

6. withpower.com withpower.com/trial/early-phase-1-developmental-delay-disorder-8-2024-664da

Parent Education for Developmental Delay The available research does not provide specific safety data for the Parent Education for Developmental Delay treatment, but similar educational and coaching ...

7. publications.aap.org publications.aap.org/pediatrics/article/119/1/182/70699/The-Importance-of-Play-in-Promoting-Healthy-Child

The Importance of Play in Promoting Healthy Child ... Play is essential to development because it contributes to the cognitive, physical, social, and emotional well-being of children and youth.