Clinical trial NCT02682043: Parental Perspectives of Using Toy Cars on Social Interactions of Preschool Children With Mobility Impairments
Official title: Parental Perspectives of Using Modified Toy Cars on the Social Interactions of Preschool Children With Mobility Impairments.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children
Mobility Limitation
Spina Bifida
Attitude to Health
Lead sponsor: University of Ulster
Sponsor class: OTHER
Collaborators: name: Belfast Health and Social Care Trust
First posted: 2016-02-15
Enrollment: 5
Sex: ALL
Minimum age (years): 12
Maximum age (years): 47
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to investigate parental attitudes towards their child who has a mobility impairment, to using a modified electric toy car, and to evaluate from their perspective, if it facilitated social interaction for their child with mobility impairment.

Detailed description: Project Aims:

The overall aim of the project is to investigate parental perspectives on the impact of using a modified electric toy car on social interactions of pre-school children with mobility impairments, over an 8 week period.

A secondary aim is to understand from the parent's perspective, features of the toy car they valued and features they feel could be changed to improve the experience for their child.

Methods:

Participants will be recruited via a charity in Northern Ireland who supports parents of children with Spina Bifida who have mobility impairments (SHINE). Once participants are confirmed, they will attend clinic appointments at Musgrave Park Hospital, Belfast. At clinic, the principle investigator will complete an assessment of the child to determine what modifications are required to support the child in the toy car as well as modifications to access drive functions.

The participants will be shown 3 possible toy car options and the child will have the opportunity to try driving the cars. Parents will then select the toy car they wish to use allowing them to consider aesthetic features. Giving the parents the option of selecting the car enhances patient and public involvement in the study.

Following this, the car will be ordered and modifications completed. The rehabilitation engineer will complete a medical device risk assessment on each car to ensure safety. A second appointment will then evaluate modifications, complete final adjustments and a safety handover.

Parents will be asked to use the toy car during social interactions with the child over an 8 week period. They will be asked to keep a log of their experiences over this time. Following this, the principle investigator will complete semi-structured interviews with the parents to determine their experiences of using the toy car.

Sample size: 5 child participants aged between 12 months and 47 months.

Outcome measures: Semi structured interviews will be completed with parents after 8 week trial intervention. In addition the PIADS will be completed before and after the trial to see if this can predict the likelihood for the parents to use the modified toy car, and what impact it has on their quality of life.

Eligibility criteria: Inclusion Criteria:

* Children aged between 12 months and 3 years, 11 months.
* Parents or Guardians aged 18 years and over, fluent English language speakers.
* Children who are unable to walk independently.
* Children who have no experience of using powered wheelchairs.
* Children who do not have a diagnosed severe learning disability.
* Children, who are medically stable, do not require ventilation or suction and can maintain upright head positioning when seated on a flat surface.

Exclusion Criteria:

* Children with a diagnosis of severe learning disability.
* Children, who are currently medically unwell, require ventilation, suction and can't maintain an upright head position when seated on a flat surface.

Primary outcomes:
measure: Parent Interview
timeFrame: on completion of 8 week trial
Secondary outcomes:
measure: Psychosocial Impact of Assistive Devices Scale (PIADS) - Jutai & Day 2002
timeFrame: Baseline and on completion of 8 week trial
Other outcomes:
Locations:
Study officials:
affiliation: University of Ulster
name: Jackie Casey, MSc
role: STUDY_CHAIR
affiliation: University of Ulster
name: Laura McKeown, PhD
role: STUDY_CHAIR
References: