Developmental Delay Clinical Trial
Official title:
Measuring the Feasibility and Preliminary Efficacy of Therapeutic Playgroups in Early Intervention
NCT number | NCT03062371 |
Other study ID # | 2015-22 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2015 |
Est. completion date | December 2022 |
Play builds social-emotional skills. Therapeutic playgroups facilitate parent-child interaction these and provide opportunities for parents to engage with their children and other adults and learn more about development. Objective: The purpose of this research is to investigate if children between the ages of 15 months and 5 years old, with and without special needs, demonstrate improved levels of playfulness and social- emotional growth after participation in a therapeutic playgroup, provided in various settings in the community. Investigators will also examine the impact that these playgroups have on participating caregiver's confidence and competence. Method: A quasi-experimental mixed methods sequential explanatory design will be used. The Test of Playfulness will measure child playfulness, the Social Profile and Assessment of Preschool Children's Participation play sub scale will determine child participation, the Devereux Early Childhood Assessment will determine social emotional growth, and the Parenting Sense of Competence Scale will determine the caregiver sense of competence. Mean differences will be analyzed using a mixed analysis of variance to determine significant changes over time for each group. Follow up surveys with parents and providers will determine parent perception of playgroup and provider perception of effectiveness and feasibility. We hypothesize that playgroups will have a significant effect on child playfulness, social-emotional growth, participation, and parent competence. We also hypothesize that participating parents will report benefits of playgroups and providers will share benefits and barriers to including therapeutic playgroups as part of comprehensive early intervention services.
Status | Recruiting |
Enrollment | 75 |
Est. completion date | December 2022 |
Est. primary completion date | August 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 15 Months to 5 Years |
Eligibility | Inclusion Criteria: - Caregivers and children ages 15 months to 5 years old - At least one caregivers must be able to attend all playgroup sessions Exclusion Criteria: -Caregivers must speak English or provide translator |
Country | Name | City | State |
---|---|---|---|
United States | Sarah Fabrizi | Fort Myers | Florida |
Lead Sponsor | Collaborator |
---|---|
Florida Gulf Coast University |
United States,
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Social Emotional status using the Devereux Early Childhood Assessment, a parent report | Use of t-score | change - week 1 and week 8 | |
Secondary | Parent Competence/ Efficacy , a Likert scale parent report | Parent report of efficacy in their role, efficacy scale is reverse coded to combine to form a total score for parent competence, higher score indicates higher level of competence | change - week 1 and week 8 | |
Secondary | Participation | Young Child Participation and Environment Measure (YC-PEM) | change - week 1 and week 8 |
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