Developmental Delay (Disorder)Early Phase 1NCT06625255
Promoting Playfulness
A Early Phase 1 study testing Parent Education - Promoting Playfulness in people with Developmental Delay (Disorder), run by Florida Gulf Coast University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Developmental Delay (Disorder)
- What is being tested?
- Parent Education - Promoting Playfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2024to 1 Oct 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parent of a child aged 2 to 5 with no major disability (sensory, intellectual disability, neuromuscular disability).
- Can commit to participating in two online sessions;
- Has a device with a stable internet connection; and
- Communicates with high school-level English.
Who cannot join
- Parents with children who have severe behavioral or sensory issues.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Little Eagles Learning Center
Fort Myers, Florida, 33908
Chantelle Yamrick, 2395907749, cyamrick@fgcu.edu
Sarah Fabrizi, 239-822-2292, sfabrizi@fgcu.edu
About this study
Official title: Promoting Playfulness: Tier 1 Strength-based Parent Education Program to Promote Child and Family Resilience
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.
Read the detailed description
Parents will be recruited through a convenience sampling method to either an intervention group delivered online or a control waitlist group. Parents will be asked to complete a set of questionnaires online to assess the proposed programs effectiveness. Data analysis will explore between and within group differences in parental sense of competency, parental stress, child's behavior, and ability to support child's play. Qualitative data will be collected through online open-ended questions and sessions' transcript which will be analyzed to identify benefits. The project will produce tangible outcomes that will contribute to fostering the resilience of families with young children.
- Conditions
- Developmental Delay (Disorder)
- Being tested
- Parent Education - Promoting Playfulness
- Keywords
- play, playfulness, parent education
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Education - Promoting PlayfulnessBehavioural
Parents will participate in 2, 45 minute parent education sessions promoting playfulness through information about child development, parent stressors, and parent advocacy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Parent Education | Experimental | 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. Receives: Behavioral: Parent Education - Promoting Playfulness |
| Waitlist control | No intervention | Parents will have family life as usual with no education sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Sense of Competence (PSOC-R)
The Parenting Sense of Competence scale (PSOC-R) is a self-report measure that aims to assesses one's perceived efficacy and satisfaction with parenting. 16 items are scored on a scale of 1-6, 1 strongly disagree to 6 strongly agree.
Measured: At the completion of two weeks
Parent/Caregiver's View of Supporting Children's Play and Playfulness
11 items scored on a scale of 0, not agree, to 2, strongly agree, to describe parent's perception of a child's play and joint play.
Measured: At the completion of two weeks
Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997)
Parental self-report assessing a child's behavior, 25 items rated on a scale ranging from 0, not true, to 2, certainly true.
Measured: At the completion of two weeks
Secondary outcomes (2)
Parent post program open-ended questions
A set of three open-ended questions about parents experience and takeaways after participation in the program.
Can the participants tell the investigators about participant experience with group training? Why do the participants think it worked well and what did not work well for the participants? How do the participants perceive play time with your child/ren now? Has anything changed after the program?
Measured: At the completion of two weeks
Parent pre program open-ended questions
A set of three questions regarding parent's expectations of the program.
The investigators would like to learn more about your thoughts and experiences and will appreciate if the participants could answer the below questions What role does play have in children's development? Do the participants have a designated time that you play with your child? can the participants tell us about it.
What do the participants expect to gain from these information sessions?
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start16 Sep 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Delay (Disorder)Studies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Flyers will be distributed, and participants will be able to contact the PI via email and use the QR code to complete the screening for eligibility. Eligibility screening will be conducted online by the prospective participant answering the following questions: (1) do you have a child aged 2 to 5? (b) do you speak and read English? and (c) can you attend two online sessions via Zoom where the content be provided via PowerPoint slides? Next, eligible participants will be asked to provide their email address and will then receive a link to complete the online consent procedure and pre-test through Qualtrics along with an assigned code to connect their pre-and-post data. The intervention group will begin when there are at least five eligible parents who consented. New enrolled parents will be waitlisted for two to three weeks after they completed the pre-program questionnaires, then after a two-week wait period they will be asked to complete the post-test Qualtrics survey 3.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida Gulf Coast University
- Sponsor type
- University, hospital or other
- Collaborators
- Yeshiva University
- Responsible party
- Principal investigator, Dr. Sarah Fabrizi, Florida Gulf Coast University
- Investigators
- Sarah Fabrizi, PhD OTR/L, Principal investigator, Associate ProfessorAMiya Waldman-Levi, PhD OTR/L, Principal investigator, Yeshiva University - Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625255
- Sponsor's protocol ID
- Protocol ID # 2024-85
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share participant data.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Playfulness: Tier 1 Strength-based Parent Education Program to Promote Child and Family Resilience
- ClinicalTrials.gov ID
- NCT06625255
- Acronym / sponsor ID
- Protocol ID # 2024-85
- Conditions
- Developmental Delay (Disorder)
- Keywords
- play, playfulness, parent education
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Florida Gulf Coast UniversityUniversity, hospital or other
- Collaborators
- Yeshiva University
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 3 Oct 2024 (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.
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.
Detailed description
Parents will be recruited through a convenience sampling method to either an intervention group delivered online or a control waitlist group. Parents will be asked to complete a set of questionnaires online to assess the proposed programs effectiveness. Data analysis will explore between and within group differences in parental sense of competency, parental stress, child's behavior, and ability to support child's play. Qualitative data will be collected through online open-ended questions and sessions' transcript which will be analyzed to identify benefits. The project will produce tangible outcomes that will contribute to fostering the resilience of families with young children.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Flyers will be distributed, and participants will be able to contact the PI via email and use the QR code to complete the screening for eligibility. Eligibility screening will be conducted online by the prospective participant answering the following questions: (1) do you have a child aged 2 to 5? (b) do you speak and read English? and (c) can you attend two online sessions via Zoom where the content be provided via PowerPoint slides? Next, eligible participants will be asked to provide their email address and will then receive a link to complete the online consent procedure and pre-test through Qualtrics along with an assigned code to connect their pre-and-post data. The intervention group will begin when there are at least five eligible parents who consented. New enrolled parents will be waitlisted for two to three weeks after they completed the pre-program questionnaires, then after a two-week wait period they will be asked to complete the post-test Qualtrics survey 3.
| Arm | Type | Receives |
|---|---|---|
| Intervention - Parent Education | Experimental | Behavioral: Parent Education - Promoting PlayfulnessParents 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. |
| Waitlist control | No intervention | –Parents will have family life as usual with no education sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Parent of a child aged 2 to 5 with no major disability (sensory, intellectual disability, neuromuscular disability).
- Can commit to participating in two online sessions;
- Has a device with a stable internet connection; and
- Communicates with high school-level English.
Key exclusion criteria (1 listed)
- Parents with children who have severe behavioral or sensory issues.
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 Education - Promoting PlayfulnessParents will participate in 2, 45 minute parent education sessions promoting playfulness through information about child development, parent stressors, and parent advocacy. | Behavioural | Intervention - Parent Education |
Primary outcome
Parental Sense of Competence (PSOC-R)
Time frame: At the completion of two weeks
The Parenting Sense of Competence scale (PSOC-R) is a self-report measure that aims to assesses one's perceived efficacy and satisfaction with parenting. 16 items are scored on a scale of 1-6, 1 strongly disagree to 6 strongly agree.
Parent/Caregiver's View of Supporting Children's Play and Playfulness
Time frame: At the completion of two weeks
11 items scored on a scale of 0, not agree, to 2, strongly agree, to describe parent's perception of a child's play and joint play.
Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997)
Time frame: At the completion of two weeks
Parental self-report assessing a child's behavior, 25 items rated on a scale ranging from 0, not true, to 2, certainly true.
2 secondary outcomes
Parent post program open-ended questions
Time frame: At the completion of two weeks
Parent pre program open-ended questions
Time frame: At enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: No. No plans to share participant data.
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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.
Sarah Fabrizi, PhD OTR/L principal investigator
Associate Professor
AMiya Waldman-Levi, PhD OTR/L principal investigator
Yeshiva University - Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Parent Education - Promoting Playfulness in people with Developmental Delay (Disorder), run by Florida Gulf Coast University at 1 site 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: looking for participants now, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah E Fabrizi, PhD OTR/L (1-239-590-1854, sfabrizi@fgcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Sense of Competence (PSOC-R) (time frame: At the completion of two weeks). 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?
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 4 Oct 2024.