Measuring the Feasibility and Preliminary Efficacy of Therapeutic Playgroups in Early Intervention
NCT ID: NCT03062371
Last Updated: 2021-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
75 participants
INTERVENTIONAL
2015-08-31
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Investigation the Effect of the Social-Communication Area Developmental Screening Test for Infants and Young Children Training Program Applied in Addition to the DIR/Floortime™ Therapy Program in Children with Developmental Risk
NCT06345170
Promoting Health Through Play Program: Improving Parent and Child Outcomes
NCT06781840
Promoting Playfulness
NCT06625255
Effects of a Short-term Parent Mediated Social Training on Developmental Trajectories in Infants
NCT03404505
Development and Effectiveness of Home-based Programs for Preschool Children With Developmental Delay
NCT02115334
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Play permits children to engage and interact with the world around them. This exploration supports the development of their social and cognitive skills needed for learning. Research has described play as the most important 'work' a child engages him or herself in. Children with developmental disabilities often have difficulties establishing peer relations. Impairments in social competence can have adverse effects on play and can result in negative behaviors that are detrimental to forming relationships. As a result, the purpose of this research study is to determine if an intervention playgroup will increase playfulness and social participation for children ages 18 months to five years. The current research will also measure parental confidence in its attempt to understand the full effect of playgroups on the family unit.
Playgroups have the potential to encourage parents, caregivers, and their children to play and have fun together safely. Playgroups offer a stimulating environment that facilitates a child's developmental needs and encourages parents to develop stable support networks. According to research, to enhance participation for children with disabilities, play must be involved in something or with someone, must offer a sense of inclusion, must have choice or control in the activity, and must be working towards a goal or enhancing the child's quality of life.
Early intervention involves establishing developmentally appropriate play as an outcome or means to achieve goals. Playgroups have the added benefit of allowing the opportunity to coach caregivers on parenting, creating social networks, forging friendships, and seeking community connectedness. Practitioners who use a family centered approach see significant improvements in both occupational performance and parent confidence . Carryover of skills from the playgroup and into the home will be accomplished through the interaction between dyads. Findings from the National Early Intervention Longitudinal Study (NEILS) showed that 98% of families participating in early intervention felt competent in caring for their children's basic needs and 90% reported that early intervention services had improved their ability to help their children develop and learn.
Playfulness is defined as the way in which the child approaches any activity or task. Arguably, playfulness can be considered more important to defining play than the play activity itself. There is a strong correlation between playfulness and coping strategies a child will use later in life. Play positively affects cognition and problem-solving, thereby increasing their coping abilities. Through play, a child develops strategies of managing and exploring a world of rich interactions.
Currently, there are limited studies describing the effectiveness of playgroups on a child's playfulness and social participation. Countries such as England and Australia have both local and national playgroup associations with established procedures for organizing and running a group headed by a team of professional coordinators. However, in the US, playgroups are sparse, less formal, and receive little to no support from national or state associations. There is a need for future research to explore the benefits of playgroups within the local community to remedy the lack of support in the US and provide an adequate play environment to children of any developmental background.
Major Research questions:
Will children ages 15 months to five years demonstrate increased playfulness and social participation after participating in playgroup? Will the caregiver of a child ages 18 months to five years report increased confidence in community outings with their child? Will providers identify benefits and barriers to providing therapeutic playgroups as part of early intervention services?
Hypothesis:
Children that participate in playgroups will show increased playfulness and social participation. Their primary caregiver will report increased confidence in community outings with their child.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Playgroup Intervention
The approach of the playgroup is to promote healthy family play routines with an emphasis on child and family well-being. The intervention types for playgroup sessions included the occupation of play, activities to promote play and participation, educating caregivers through modeling and coaching, advocating for the child and family, and the use of group sessions. Specific playgroup strategies included a predictable routine, following the child's lead, imitating the child, modeling of new behaviors, and scaffolding play - within both the social and physical environment. When developing activities, play objects that families have at home and are easily obtained were used and positioned intentionally with respect to the child-caregiver dyad and the group as a whole.
Playgroup
A semi-structured gathering of caregivers and their children in a community setting developed and implemented by a skilled provider.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Playgroup
A semi-structured gathering of caregivers and their children in a community setting developed and implemented by a skilled provider.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* At least one caregivers must be able to attend all playgroup sessions
Exclusion Criteria
15 Months
5 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Florida Gulf Coast University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Sarah Fabrizi
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sarah Fabrizi, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sarah Fabrizi
Fort Myers, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Andrews F, Griffiths N, Harrison L, Stagnitti K. Expectations of parents on low incomes and therapists who work with parents on low incomes of the first therapy session. Aust Occup Ther J. 2013 Dec;60(6):436-44. doi: 10.1111/1440-1630.12044. Epub 2013 Jun 18.
Bundy, A. (2010). Test of playfulness (ToP) 4.2 manual revised 11/10. Lidcombe, Australia: University of Sydney.
Cameron D, Leslie M, Teplicky R, Pollock N, Stewart D, Toal C, Gaik S. The clinical utility of the test of playfulness. Can J Occup Ther. 2001 Apr;68(2):104-11. doi: 10.1177/000841740106800206.
Case-Smith J. Systematic reviews of the effectiveness of interventions used in occupational therapy early childhood services. Am J Occup Ther. 2013 Jul-Aug;67(4):379-82. doi: 10.5014/ajot.2013.007872. No abstract available.
Donohue, M.V. (2013). Social profile: Assessment of social participation in children, dolescents, and adults. Retrieved from http://myaota.aota.org/shop_aota/prodview.aspx?TYPE=D&PID=160964175&SKU=124 4
Ginsburg KR; American Academy of Pediatrics Committee on Communications; American Academy of Pediatrics Committee on Psychosocial Aspects of Child and Family Health. The importance of play in promoting healthy child development and maintaining strong parent-child bonds. Pediatrics. 2007 Jan;119(1):182-91. doi: 10.1542/peds.2006-2697.
Graham F, Rodger S, Ziviani J. Effectiveness of occupational performance coaching in improving children's and mothers' performance and mothers' self-competence. Am J Occup Ther. 2013 Jan-Feb;67(1):10-8. doi: 10.5014/ajot.2013.004648.
Hoogsteen L, Woodgate RL. Can I play? A concept analysis of participation in children with disabilities. Phys Occup Ther Pediatr. 2010 Nov;30(4):325-39. doi: 10.3109/01942638.2010.481661.
Johnston, C., & Mash, E.J. (1989). A measures of parenting satisfaction and efficacy. Journal of Clinical Child Psychology, 18,167-175. Retrieved from https://researchingparents.wordpress.com/2013/02/15/parenting-sense-of-competence- psoc/
Mize, J., & Pettit G.S. (2010). The mother-child playgroup as socialisation context: a short-term longitudinal study of mother-child-peer relationship dynamics. Early Child Development and Care, 180(10), 1271-1284. DOI: 10.1080/0300443090298147
O'Brien J, Coker P, Lynn R, Suppinger R, Pearigen T, Rabon S, St Aubin M, Ward AT. The Impact of Occupational Therapy on a Child's Playfulness. Occup Ther Health Care. 2000;12(2-3):39-51. doi: 10.1080/J003v12n02_03.
Strange C, Fisher C, Howat P, Wood L. Fostering supportive community connections through mothers' groups and playgroups. J Adv Nurs. 2014 Dec;70(12):2835-46. doi: 10.1111/jan.12435. Epub 2014 May 7.
Saunders I, Sayer M, Goodale A. The relationship between playfulness and coping in preschool children: a pilot study. Am J Occup Ther. 1999 Mar-Apr;53(2):221-6. doi: 10.5014/ajot.53.2.221.
Vedeler, L. (2004). Social coping strategies in pre-school play. How do children with disabilities succeed in play groups with other children? Scandinavian Journal of Disability Research, 6(3), 192-205, DOI: 10.1080/15017410409512652
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-22
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.