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

Trial Summary

What is the purpose of this trial?

Health inequalities, social isolation, and family adversity impact a child's development. Play is the context for child development in all areas. A parent's ability to support children at play while being playful contributes to their psychological adjustment. The proposed tier 1, strengths-based educational program for parents of children aged 2 to 5 years with and without disabilities combines elements of a play-based approach and tips on effective parenting to support children's development by equipping parents with knowledge and empowering them to become change agents in their children's lives.

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 data supports the effectiveness of the treatment Promoting Playfulness for developmental delay?

Research on similar treatments, like the LEaP playgroup, shows that structured play interventions can improve family support and help children with developmental delays achieve their goals. Additionally, developmental education for parents has been shown to increase parental involvement and children's skill development, suggesting that parent-focused interventions can be beneficial. ^{1 2 3 4 5}

Is the Parent Education for Developmental Delay treatment safe for humans?

The available research does not provide specific safety data for the Parent Education for Developmental Delay treatment, but similar educational and coaching interventions for parents of children with developmental delays have been studied without reported safety concerns. ^{1 3 4 6 7}

How is the treatment 'Promoting Playfulness' different from other treatments for developmental delay?

Promoting Playfulness is unique because it focuses on enhancing parent-child interactions and playfulness, which can improve family support and goal achievement for children with developmental delays. Unlike other treatments, it emphasizes the role of parents in facilitating play, which is crucial for child development. ^{1 4 8 9 10}

Research Team

AMiya Waldman-Levi, PhD OTR/L

Principal Investigator

Yeshiva University - Professor

Sarah Fabrizi, PhD OTR/L

Principal Investigator

Associate Professor

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

References

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

Developmental education for parents of delayed infants: effects on parental motivation and children's development. [2006]

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

Parental behavior and child interactive engagement: a longitudinal study on children with a significant cognitive and motor developmental delay. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Patient engagement in an online coaching intervention for parents of children with suspected developmental delays. [2021]

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

Randomised Controlled Trial of a Therapeutic Playgroup for Children with Developmental Delays. [2021]

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

Correlations between functional performance, health-related quality of life, and parental impact on children with developmental delays. [2018]

6. Brazil pubmed.ncbi.nlm.nih.gov

Ludic strategy for promoting engagement of parents and caregivers in the safety of pediatric patients. [2021]

7. Switzerland 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. [2020]

8. England 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. [2006]

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

Parents' awareness, knowledge, and experiences of play and its benefits in child development: A systematic review protocol. [2022]

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

Play interactions of parents toward children with autism spectrum disorder: NeuroPLAY parent play behavior assessment scale. [2021]