Developmental DelayNCT03062371
Measuring the Feasibility and Preliminary Efficacy of Therapeutic Playgroups in Early Intervention
A study testing Playgroup in people with Developmental Delay, run by Florida Gulf Coast University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Delay
- What is being tested?
- Playgroup
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Caregivers and children ages 15 months to 5 years old
- At least one caregivers must be able to attend all playgroup sessions
Who cannot join
- -Caregivers must speak English or provide translator
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Sarah Fabrizi
Fort Myers, Florida, 33908
Sarah Fabrizi, PhD, 239-590-1854, sfabrizi@fgcu.edu
About this study
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.
Read the 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.
- Conditions
- Developmental Delay
- Being tested
- Playgroup
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaygroupBehavioural
Also called community playgroup, developmental playgroup
A semi-structured gathering of caregivers and their children in a community setting developed and implemented by a skilled provider.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Playgroup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Emotional status using the Devereux Early Childhood Assessment, a parent report
Use of t-score
Measured: change - week 1 and week 8
Secondary outcomes (2)
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
Measured: change - week 1 and week 8
Participation
Young Child Participation and Environment Measure (YC-PEM)
Measured: change - week 1 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startAug 2015
- Primary completionAug 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Developmental DelayStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida Gulf Coast University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sarah Fabrizi, Florida Gulf Coast University
- Investigators
- Sarah Fabrizi, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062371
- Sponsor's protocol ID
- 2015-22
- Status last verified
- Aug 2021
- First submitted
- 13 Feb 2017
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24299483Bundy, 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.
PubMed 11355615Case-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.
PubMed 23791311Donohue, 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.
PubMed 17200287Graham 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.
PubMed 23245778Hoogsteen 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.
PubMed 20735196Johnston, 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.
PubMed 23951988Strange 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.
PubMed 24805198Saunders 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.
PubMed 10200846Vedeler, 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Feasibility and Preliminary Efficacy of Therapeutic Playgroups in Early Intervention
- ClinicalTrials.gov ID
- NCT03062371
- Acronym / sponsor ID
- 2015-22
- Conditions
- Developmental Delay
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Florida Gulf Coast UniversityUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 23 Feb 2017 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Playgroup Intervention | Experimental | Behavioral: PlaygroupThe 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. |
Who may qualify
- Ages
- 15 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Caregivers and children ages 15 months to 5 years old
- At least one caregivers must be able to attend all playgroup sessions
Key exclusion criteria (1 listed)
- -Caregivers must speak English or provide translator
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 |
|---|---|---|
| PlaygroupAlso: community playgroup, developmental playgroupA semi-structured gathering of caregivers and their children in a community setting developed and implemented by a skilled provider. | Behavioural | Playgroup Intervention |
Primary outcome
Social Emotional status using the Devereux Early Childhood Assessment, a parent report
Time frame: change - week 1 and week 8
Use of t-score
2 secondary outcomes
Parent Competence/ Efficacy , a Likert scale parent report
Time frame: change - week 1 and week 8
Participation
Time frame: change - week 1 and week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Background: PubMed 24299483Andrews 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.
- BackgroundBundy, A. (2010). Test of playfulness (ToP) 4.2 manual revised 11/10. Lidcombe, Australia: University of Sydney.
- Background: PubMed 11355615Cameron 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.
- Background: PubMed 23791311Case-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.
- BackgroundDonohue, 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: PubMed 17200287Ginsburg 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.
- Background: PubMed 23245778Graham 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.
- Background: PubMed 20735196Hoogsteen 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.
- BackgroundJohnston, 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/
- BackgroundMize, 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: PubMed 23951988O'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.
- Background: PubMed 24805198Strange 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.
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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. This study is not recruiting at the moment.
Sarah Fabrizi, PhD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Playgroup in people with Developmental Delay, 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 2 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: status not confirmed, as of the sponsor's last update on 2 Sep 2021. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Fabrizi, PhD (2395901854, sfabrizi@fgcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Emotional status using the Devereux Early Childhood Assessment, a parent report (time frame: change - week 1 and week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03062371, which also lists 14 linked publications.
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 2 Sep 2021.