NCT03062371

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

7 years

First QC Date

February 13, 2017

Last Update Submit

August 30, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Social Emotional status using the Devereux Early Childhood Assessment, a parent report

    Use of t-score

    change - week 1 and week 8

Secondary Outcomes (2)

  • Parent Competence/ Efficacy , a Likert scale parent report

    change - week 1 and week 8

  • Participation

    change - week 1 and week 8

Study Arms (1)

Playgroup Intervention

EXPERIMENTAL

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

Interventions

PlaygroupBEHAVIORAL

A semi-structured gathering of caregivers and their children in a community setting developed and implemented by a skilled provider.

Also known as: community playgroup, developmental playgroup
Playgroup Intervention

Eligibility Criteria

Age15 Months - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Caregivers and children ages 15 months to 5 years old
  • At least one caregivers must be able to attend all playgroup sessions

You may not qualify if:

  • Caregivers must speak English or provide translator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sarah Fabrizi

Fort Myers, Florida, 33908, United States

RECRUITING

Related Publications (14)

  • 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.

    PMID: 24299483BACKGROUND
  • Bundy, A. (2010). Test of playfulness (ToP) 4.2 manual revised 11/10. Lidcombe, Australia: University of Sydney.

    BACKGROUND
  • 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.

    PMID: 11355615BACKGROUND
  • 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.

    PMID: 23791311BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 17200287BACKGROUND
  • 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.

    PMID: 23245778BACKGROUND
  • 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.

    PMID: 20735196BACKGROUND
  • 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/

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 23951988BACKGROUND
  • 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.

    PMID: 24805198BACKGROUND
  • 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.

    PMID: 10200846BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

Learning Disabilities

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Sarah Fabrizi, PhD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Fabrizi, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 23, 2017

Study Start

August 1, 2015

Primary Completion

August 1, 2022

Study Completion

December 1, 2022

Last Updated

September 2, 2021

Record last verified: 2021-08

Locations