ParentingHSHNCT03965377
Developing an Injury Prevention Simulation Game to Better Engage Parents in Services -Home Safety Hero
A study testing Home Safety Hero Computer Game in people with Parenting, run by Penn State University at 1 site in United States.
Trial summary
This study will test the effectiveness of novel technology-based game to teach parents and parents to be home safety skills. These include the identification of home child injury risks under two conditions (with and without distraction) and how to resolve these risks to better protect preschool children from injuries. Read more about this study
- Who is it for?
- Ages 12 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Parenting
- What is being tested?
- Home Safety Hero Computer Game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2019to 30 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 12 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Inclusion Criteria:participants who are parents or parents to be from a high school program in Altoona, PA. For those less than age 18, parental permission for participation is required
-
Exclusion Criteria: non-English Speaking; ones whose due date falls in the study period and who are not likely to complete the project.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Injuries Aren't Part of the Game: Developing an Injury Prevention Simulation Game to Better Engage Parents in Services
This study will test the effectiveness of novel technology-based game to teach parents and parents to be home safety skills. These include the identification of home child injury risks under two conditions (with and without distraction) and how to resolve these risks to better protect preschool children from injuries. Few empirically validated home safety interventions exist and the best ones involve individual home visitors. These and others that use didactic instruction or provision of written material have poor response from low socioeconomic parents who are less literate and more resistant to outsiders entering their homes. The use of a computer game to provide education in this area is being tested for effectiveness and the game's engagement will also be examined.
Given cognitive problems in parents have been linked in the PI's work to child neglect (e.g., poor child supervision), links of performance on the game to cognitive capacities will also be examined in a preliminary way.
Read the detailed description
The study will compare a group of parents and parents to be who play the game multiple times (n=15) to a wait list group (n=15) who just play it once. The study will examine reaction times to identification and resolution of the risks overall and by category of risk (e.g., poisoning, burns, suffocation, etc.). The study will also examine failures on levels of the game which are graded for difficulty. The game was designed for low failure rate to increase engagement and to improve motivation.
Changes in the participants' perception of efficacy in preventing injuries to children and their engagement with the game (using a standardized usability survey) will be examined. The study will also examine the role of experience with the use of technology and cognitive capacities in relation to performance and pre-post changes with multiple plays of the game.
- Conditions
- Parenting
- Being tested
- Home Safety Hero Computer Game
- Keywords
- effectiveness of gaming technology, knowledge of childhood injury prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Safety Hero Computer GameBehavioural
Home Safety Hero computer game presents players with virtual rooms in a home where vilians have planted safety risks. It involves the player taking the role of a body guard for a child. It has three phases: 1. Identifying risks in a set of rooms (e.g., burn, falling, suffocation, poisoning); 2. Identifying risks and then selecting a resolution to reduce the risk or eliminate it entirely; and 3. Identifying risk when faced with distractions typical to home environments (e.g., phone ringing, fire engine siren sounds, a moving child).
| Study group | Role | What they receive |
|---|---|---|
| Home Safety Hero game play | Experimental | Home Safety Hero is parental psychoeducational computer game to prevent childhood injuries Receives: Behavioral: Home Safety Hero Computer Game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Learning
The game is designed to improve speed of identifying home safety hazards with and without distractions and also identify effective resolutions of the risks. Speed in identification is measured in seconds. Effectiveness in identifying resolutions is measured in seconds as well (e.g., seconds til correct response). Average time to identification of risks in each of the three phases of the game can be computed (Identification Phase, Resolution Phase, and Distraction Phase). The game will also give whether the resolutions selected are correct and thus, a percentage of correct resolutions can be computed for the entire resolution phase.
Measured: one week (four plays of the game) The outcomes average seconds until identification will be examined across the four game plays and also can be examined for each of four plays of the game.
Secondary outcomes (2)
:Perception of efficacy in preventing childhood injuries: PARENT SENSE OF INJURY COMPETENCE SCALE
The participants' change in perception of efficacy in preventing childhood injuries
Measured: pre and one week later This outcome will be measured using PARENT SENSE OF INJURY COMPETENCE SCALE. This instrument has 16 items that are rated on a 1-6 scale with 6 indicating greater efficacy. The items are totaled for overall efficacy perception.
Engagement in the game
A survey instrument [Usability Survey (UES)] will be collected that measures engagement in the game. This instrument has 26 items that assess engagement with the game rated on a five point scale from strongly disagree (1) to strongly agree (5). The ratings are totalled for an overall engagement score and this will be used to measure engagement.
Measured: This instrument is collected one time at post test once they have completed game play. The time frame is one week after entering the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start6 Feb 2019
- Primary completion31 Aug 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentingStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- teen parents and parents to be will be randomly assigned to game play (4 vs 1) to assess the effectiveness of the computer game to decrease time to identifying home hazards, improve identification of resolutions of hazards, and time to identify home hazards under distraction conditions
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Azar, Penn State University
- Investigators
- Sandra T Azar, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965377
- Sponsor's protocol ID
- STUDY00008278
- Acronym
- HSH
- Status last verified
- Dec 2021
- First submitted
- 10 Apr 2019
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injuries Aren't Part of the Game: Developing an Injury Prevention Simulation Game to Better Engage Parents in Services
- ClinicalTrials.gov ID
- NCT03965377
- Acronym / sponsor ID
- HSH / STUDY00008278
- Conditions
- Parenting
- Keywords
- effectiveness of gaming technology, knowledge of childhood injury prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 29 May 2019 (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.
This study will test the effectiveness of novel technology-based game to teach parents and parents to be home safety skills. These include the identification of home child injury risks under two conditions (with and without distraction) and how to resolve these risks to better protect preschool children from injuries. Few empirically validated home safety interventions exist and the best ones involve individual home visitors. These and others that use didactic instruction or provision of written material have poor response from low socioeconomic parents who are less literate and more resistant to outsiders entering their homes. The use of a computer game to provide education in this area is being tested for effectiveness and the game's engagement will also be examined.
Given cognitive problems in parents have been linked in the PI's work to child neglect (e.g., poor child supervision), links of performance on the game to cognitive capacities will also be examined in a preliminary way.
Detailed description
The study will compare a group of parents and parents to be who play the game multiple times (n=15) to a wait list group (n=15) who just play it once. The study will examine reaction times to identification and resolution of the risks overall and by category of risk (e.g., poisoning, burns, suffocation, etc.). The study will also examine failures on levels of the game which are graded for difficulty. The game was designed for low failure rate to increase engagement and to improve motivation.
Changes in the participants' perception of efficacy in preventing injuries to children and their engagement with the game (using a standardized usability survey) will be examined. The study will also examine the role of experience with the use of technology and cognitive capacities in relation to performance and pre-post changes with multiple plays of the game.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- teen parents and parents to be will be randomly assigned to game play (4 vs 1) to assess the effectiveness of the computer game to decrease time to identifying home hazards, improve identification of resolutions of hazards, and time to identify home hazards under distraction conditions
| Arm | Type | Receives |
|---|---|---|
| Home Safety Hero game play | Experimental | Behavioral: Home Safety Hero Computer GameHome Safety Hero is parental psychoeducational computer game to prevent childhood injuries |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Home Safety Hero Computer GameHome Safety Hero computer game presents players with virtual rooms in a home where vilians have planted safety risks. It involves the player taking the role of a body guard for a child. It has three phases: 1. Identifying risks in a set of rooms (e.g., burn, falling, suffocation, poisoning); 2. Identifying risks and then selecting a resolution to reduce the risk or eliminate it entirely; and 3. Identifying risk when faced with distractions typical to home environments (e.g., phone ringing, fire engine siren sounds, a moving child). | Behavioural | Home Safety Hero game play |
Primary outcome
Learning
Time frame: one week (four plays of the game) The outcomes average seconds until identification will be examined across the four game plays and also can be examined for each of four plays of the game.
The game is designed to improve speed of identifying home safety hazards with and without distractions and also identify effective resolutions of the risks. Speed in identification is measured in seconds. Effectiveness in identifying resolutions is measured in seconds as well (e.g., seconds til correct response). Average time to identification of risks in each of the three phases of the game can be computed (Identification Phase, Resolution Phase, and Distraction Phase). The game will also give whether the resolutions selected are correct and thus, a percentage of correct resolutions can be computed for the entire resolution phase.
2 secondary outcomes
:Perception of efficacy in preventing childhood injuries: PARENT SENSE OF INJURY COMPETENCE SCALE
Time frame: pre and one week later This outcome will be measured using PARENT SENSE OF INJURY COMPETENCE SCALE. This instrument has 16 items that are rated on a 1-6 scale with 6 indicating greater efficacy. The items are totaled for overall efficacy perception.
Engagement in the game
Time frame: This instrument is collected one time at post test once they have completed game play. The time frame is one week after entering the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Sandra T Azar, PhD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Safety Hero Computer Game in people with Parenting, run by Penn State 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?
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 8 Dec 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Learning (time frame: one week (four plays of the game) The outcomes average seconds until identification will be examined across the four game plays and also can be examined for each of four plays of the game.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2021.