Measuring the Feasibility and Preliminary Efficacy of Therapeutic Playgroups in Early Intervention

August 30, 2021 updated by: Dr. Sarah Fabrizi, Florida Gulf Coast University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

All children have the right to play; the right to play is enshrined in Article 31 of the UN Convention on the Rights of the Child. Play is the fundamental way that children enjoy their childhood. It is essential to their quality of life as children.

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.

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Fort Myers, Florida, United States, 33908
        • Recruiting
        • Sarah Fabrizi
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Playgroup
A semi-structured gathering of caregivers and their children in a community setting developed and implemented by a skilled provider.
Other Names:
  • community playgroup, developmental playgroup

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social Emotional status using the Devereux Early Childhood Assessment, a parent report
Time Frame: change - week 1 and week 8
Use of t-score
change - week 1 and week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent Competence/ Efficacy , a Likert scale parent report
Time Frame: change - week 1 and week 8
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
Participation
Time Frame: change - week 1 and week 8
Young Child Participation and Environment Measure (YC-PEM)
change - week 1 and week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida Gulf Coast University

Investigators

  • Principal Investigator: Sarah Fabrizi, PhD, Assistant Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

February 13, 2017

First Submitted That Met QC Criteria

February 20, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

September 2, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2015-22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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