Injury in the HomeCHIPNCT01327092
Cincinnati Home Injury Prevention Study
A study testing Injury Intervention Group in people with Injury in the Home, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
One aim of this study is to test the efficacy of the installation of multiple, passive measures to reduce exposure to injury hazards in the homes of young children of first-time mothers and reduce childhood injury. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Injury in the Home
- What is being tested?
- Injury Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jul 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mothers enrolled in the ECS program who have completed at least one ECS home visit
Who cannot join
- Have a child greater than 5 months of age
- Are non-English speaking
- Live beyond a 3-hr driving radius
- Have plans to relocate outside of a 3-hour driving radius from Cincinnati Children's Hospital in the next 12 months at the time of screening
- Mothers with ECS accounts marked as "Other" such as HMG Part C (having a chronic illness, congenital disorder or developmental delay), HMG At-Risk, first time fathers in Kentucky, etc.
- index child is a twin
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
About this study
Official title: Injury Prevention in a Home Visitation Population
One aim of this study is to test the efficacy of the installation of multiple, passive measures to reduce exposure to injury hazards in the homes of young children of first-time mothers and reduce childhood injury. The study also seeks to identify sub-groups of mothers and children who benefit most from the intervention and examine the potential moderating effect of maternal depressive symptoms, the intensity of supervisory behavior, and child temperament and activity, on the intervention and subsequent injury outcomes.
Specific Aim 1 Hypotheses:
Read more
H1.1: The housing units randomly assigned to the intervention group will have a significant decrease in the number and density (number per area) of residential injury-related hazards compared with control group units.
H1.2: Children who are randomized to the intervention group (e.g. installation of multiple, passive measures to reduce exposure to residential injury hazards) will have a 50% reduction in modifiable and medically-attended injuries compared with children in the control group followed-up for 24-months in intention-to-treat analyses.
Specific Aim 2: Hypotheses H2.1: Persistent maternal depressive symptoms will moderate the effects of the intervention on childhood injury in the home; households and children of mothers with higher levels of symptoms will have more hazards and injuries.
H2.2: Children of mothers with less intense maternal supervisory behavior over the course of the intervention follow-up will have higher rates of injury.
H2.3: Children scoring high in activity on the Carey Temperament Scale will experience reduced benefits of the intervention on childhood injury in the home.
Read the detailed description
Injury remains the leading cause of morbidity and mortality for U.S. children after the first year of life and the home is the leading location of injury for younger U.S. children. Residential injury results in more than 1.7 million emergency visits in children younger than 5 years of age annually in the U.S. resulting in over $3 billion in medical care costs and $800 per emergency visit. Therefore, interventions that can effect sizable reductions in childhood injury in the home could result in substantial reductions in pain and suffering while saving potentially hundreds of millions of dollars in healthcare costs.
Previous trials have failed to achieve comprehensive and durable installation of home safety products to reduce exposure to injury hazards in the indoor environments of young children. Children of mothers who are eligible and enrolled in home visitation programs and children of mothers with elevated depressive symptoms have been shown to be at risk for injury in the home. Inadequate maternal supervisory behavior has also been shown to increase the risk for home injury. This project will test the efficacy of an intervention to reduce exposure to injury hazards in the home and subsequent preventable and medically attended injury in young children of first-time, impoverished mothers.
This randomized control trial will test the efficacy of a public health intervention to reduce exposure to injury hazards through the proper installation of safety devices in the home and subsequent preventable and medically attended injury in the Every Child Succeeds (ECS) population. Participants will be randomized to either receive injury prevention measures or be a part of a literacy effort that provides developmentally appropriate books and reading materials to mothers and children, and encourages mothers to gain interest in reading with their child.
Mothers that participate in the Every Child Succeeds (ECS) home visitation program, have completed at least one ECS home visit, and have a child less than 5 months of age will be enrolled in the study. Index children will be followed for 24 months after randomization and interventions or up to the age of approximately 36 months. Measures of maternal and child psychology, child behavior and temperament will be obtained during home visits. Maternal supervision and childhood injuries will be assessed repeatedly during quarterly phone questionnaires and home visits.
Experimental Group: In homes of children randomized to the intervention arm of the trial, a comprehensive observational survey of living spaces will be undertaken. The study will examine living spaces to which a child may be exposed including 5 high-exposure, high-risk areas (main activity room, kitchen, child's bedroom and bathrooms, and stairways). In addition to quantifying hazards, the area of rooms will be obtained allowing for determination of both the number and density of injury hazards.
The hazards identified by the intervention team will be reviewed with the parent and the proposed interventions will be presented. Intervention options are designed and prioritized so that the most passive and durable interventions are recommended first and progressively less 'passive' and less durable options last. After consent is obtained, passive measures will be installed across the living space as indicated.
One goal of the study is to determine whether installed products that modify exposure to the injury hazards can reduce unintentional injury across the leading mechanisms for young children over time. Another goal is to determine the required maintenance of installed products over time. At routine home visits or at the request of a participant prior to the 18-month follow-up time point, installed interventions will be assessed for their presence and function and broken or malfunctioning products will be repaired or replaced if it is within the study budget. Additionally, if the study budget allows, the investigators will repeat the injury hazard survey and perform the installation intervention if a family relocates prior to the child being 24-months of age, within a 3 hour driving radius of CCHMC, and has not moved more than three times.
Control Group: Mothers and children randomly assigned to the control condition will also benefit from participation in the trial. Similar to the intervention arm, they will undergo home surveys and annual visits for assessment of injury hazards. In addition, families in this control group will receive a program which seeks to promote literacy by providing developmentally appropriate books, materials and possibly a library card to children and encouraging mothers to develop an interest in reading with their child. After enrollment and randomization, CHIP staff will visit these control group homes, assess the mother's interest in and barriers to reading with her child, and council mothers about the importance of literacy and reading books to their child.
- Conditions
- Injury in the Home
- Being tested
- Injury Intervention Group
- Keywords
- Injury, Injury Prevention, Cincinnati Home Injury Prevention, Injury Hazards, Modifiable Injury Hazards, CHIP, Literacy Promotion, Reduce exposure to injury hazards, preventable and medically attended injury, young children
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injury Intervention GroupOther
The hazards identified in the home will be reviewed with the parent and the proposed interventions will be presented. Intervention options are designed and prioritized so that the most passive and durable interventions are recommended first (e.g. self-closing, self-locking stair gate) and progressively less 'passive' and less durable options last (e.g. area gate, pressure mounted gate, or refusal of intervention).
| Study group | Role | What they receive |
|---|---|---|
| Literacy Group | No intervention | Families in the Literacy Group (control group)will receive a program which seeks to promote literacy by providing developmentally appropriate books and other reading-related materials to children and encouraging mothers to develop an interest in reading with their child. After enrollment and randomization, CHIP staff will visit these control group homes, assess the mother's interest in and barriers to reading with her child, council mothers about the importance of literacy and reading books to their child, and children will be given age appropriate books and other materials to promote literacy. |
| Injury Intervention Group | Experimental | Injury Intervention Group: In homes of children who are randomized to the injury intervention arm of the trial, a comprehensive survey of injury hazards in living spaces will be undertaken. In addition to quantifying hazards, the area of living spaces will be obtained to allow the determination of both the number and density (number of hazards per 100 sq ft) of injury hazards. If one or more injury hazards are identified, they will be removed and/or modified to reduce exposure and injury risk. The intervention is focused on areas in living spaces below 1 meter (~39 inches) in height from (the 75th percentile in height or eye-level for a 3-year old US male toddler) which might be easily reached or climbed on by children less than 4 years Receives: Other: Injury Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any modifiable and medically-attended injury in enrolled children
Primary outcome measures will include any phone calls, clinic, and ED visits for falls, cuts/lacerations, contusion/crush, burn/scald, abrasions, and poisoning injuries sustained by enrolled children in the home that were potentially modifiable by the installed safety products. Modifiable injury events are defined as those whose hazard exposure and associated mechanism was potentially modified by the intervention (ie stairgate reducing exposure to a stairway and subsequent stairway fall injury) and include fall, cut/pierce, struck/strike, burn, and poisoning mechanisms.
Measured: Quarterly (baseline & annual home visits, quarterly phone surveys) (up to 4 years)
Secondary outcomes (1)
Correlation of self-reports of non-emergent but medically attended residential injuries in enrolled children.
Verification of self-reports will be accomplished through annual medical record review. Emergency visit reports will be confirmed by matching the maternal report to the Hamilton County Injury Surveillance System (HCISS) a data repository of all injuries resulting in emergency visits, hospitalizations, and deaths for all persons presenting to Hamilton County hospitals and emergency departments.
Measured: Annually (up to 4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study startSep 2010
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Injury in the HomeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Kieran Phelan, Children's Hospital Medical Center, Cincinnati
- Investigators
- Kieran Phelan, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327092
- Sponsor's protocol ID
- 1R01HD066115-01A1
- Acronym
- CHIP
- Status last verified
- Dec 2015
- First submitted
- 30 Mar 2011
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Phelan KJ, Khoury J, Xu Y, Lanphear B. Validation of a HOME Injury Survey. Inj Prev. 2009 Oct;15(5):300-6. doi: 10.1136/ip.2008.020958.
PubMed 19805597
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injury Prevention in a Home Visitation Population
- ClinicalTrials.gov ID
- NCT01327092
- Acronym / sponsor ID
- CHIP / 1R01HD066115-01A1
- Conditions
- Injury in the Home
- Keywords
- Injury, Injury Prevention, Cincinnati Home Injury Prevention, Injury Hazards, Modifiable Injury Hazards, CHIP, Literacy Promotion, Reduce exposure to injury hazards
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 1 Apr 2011 (estimated)
- 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.
One aim of this study is to test the efficacy of the installation of multiple, passive measures to reduce exposure to injury hazards in the homes of young children of first-time mothers and reduce childhood injury. The study also seeks to identify sub-groups of mothers and children who benefit most from the intervention and examine the potential moderating effect of maternal depressive symptoms, the intensity of supervisory behavior, and child temperament and activity, on the intervention and subsequent injury outcomes.
Specific Aim 1 Hypotheses:
H1.1: The housing units randomly assigned to the intervention group will have a significant decrease in the number and density (number per area) of residential injury-related hazards compared with control group units.
H1.2: Children who are randomized to the intervention group (e.g. installation of multiple, passive measures to reduce exposure to residential injury hazards) will have a 50% reduction in modifiable and medically-attended injuries compared with children in the control group followed-up for 24-months in intention-to-treat analyses.
Specific Aim 2: Hypotheses H2.1: Persistent maternal depressive symptoms will moderate the effects of the intervention on childhood injury in the home; households and children of mothers with higher levels of symptoms will have more hazards and injuries.
H2.2: Children of mothers with less intense maternal supervisory behavior over the course of the intervention follow-up will have higher rates of injury.
H2.3: Children scoring high in activity on the Carey Temperament Scale will experience reduced benefits of the intervention on childhood injury in the home.
Detailed description
Injury remains the leading cause of morbidity and mortality for U.S. children after the first year of life and the home is the leading location of injury for younger U.S. children. Residential injury results in more than 1.7 million emergency visits in children younger than 5 years of age annually in the U.S. resulting in over $3 billion in medical care costs and $800 per emergency visit. Therefore, interventions that can effect sizable reductions in childhood injury in the home could result in substantial reductions in pain and suffering while saving potentially hundreds of millions of dollars in healthcare costs.
Previous trials have failed to achieve comprehensive and durable installation of home safety products to reduce exposure to injury hazards in the indoor environments of young children. Children of mothers who are eligible and enrolled in home visitation programs and children of mothers with elevated depressive symptoms have been shown to be at risk for injury in the home. Inadequate maternal supervisory behavior has also been shown to increase the risk for home injury. This project will test the efficacy of an intervention to reduce exposure to injury hazards in the home and subsequent preventable and medically attended injury in young children of first-time, impoverished mothers.
This randomized control trial will test the efficacy of a public health intervention to reduce exposure to injury hazards through the proper installation of safety devices in the home and subsequent preventable and medically attended injury in the Every Child Succeeds (ECS) population. Participants will be randomized to either receive injury prevention measures or be a part of a literacy effort that provides developmentally appropriate books and reading materials to mothers and children, and encourages mothers to gain interest in reading with their child.
Mothers that participate in the Every Child Succeeds (ECS) home visitation program, have completed at least one ECS home visit, and have a child less than 5 months of age will be enrolled in the study. Index children will be followed for 24 months after randomization and interventions or up to the age of approximately 36 months. Measures of maternal and child psychology, child behavior and temperament will be obtained during home visits. Maternal supervision and childhood injuries will be assessed repeatedly during quarterly phone questionnaires and home visits.
Experimental Group: In homes of children randomized to the intervention arm of the trial, a comprehensive observational survey of living spaces will be undertaken. The study will examine living spaces to which a child may be exposed including 5 high-exposure, high-risk areas (main activity room, kitchen, child's bedroom and bathrooms, and stairways). In addition to quantifying hazards, the area of rooms will be obtained allowing for determination of both the number and density of injury hazards.
The hazards identified by the intervention team will be reviewed with the parent and the proposed interventions will be presented. Intervention options are designed and prioritized so that the most passive and durable interventions are recommended first and progressively less 'passive' and less durable options last. After consent is obtained, passive measures will be installed across the living space as indicated.
One goal of the study is to determine whether installed products that modify exposure to the injury hazards can reduce unintentional injury across the leading mechanisms for young children over time. Another goal is to determine the required maintenance of installed products over time. At routine home visits or at the request of a participant prior to the 18-month follow-up time point, installed interventions will be assessed for their presence and function and broken or malfunctioning products will be repaired or replaced if it is within the study budget. Additionally, if the study budget allows, the investigators will repeat the injury hazard survey and perform the installation intervention if a family relocates prior to the child being 24-months of age, within a 3 hour driving radius of CCHMC, and has not moved more than three times.
Control Group: Mothers and children randomly assigned to the control condition will also benefit from participation in the trial. Similar to the intervention arm, they will undergo home surveys and annual visits for assessment of injury hazards. In addition, families in this control group will receive a program which seeks to promote literacy by providing developmentally appropriate books, materials and possibly a library card to children and encouraging mothers to develop an interest in reading with their child. After enrollment and randomization, CHIP staff will visit these control group homes, assess the mother's interest in and barriers to reading with her child, and council mothers about the importance of literacy and reading books to their child.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Literacy Group | No intervention | –Families in the Literacy Group (control group)will receive a program which seeks to promote literacy by providing developmentally appropriate books and other reading-related materials to children and encouraging mothers to develop an interest in reading with their child. After enrollment and randomization, CHIP staff will visit these control group homes, assess the mother's interest in and barriers to reading with her child, council mothers about the importance of literacy and reading books to their child, and children will be given age appropriate books and other materials to promote literacy. |
| Injury Intervention Group | Experimental | Other: Injury Intervention GroupInjury Intervention Group: In homes of children who are randomized to the injury intervention arm of the trial, a comprehensive survey of injury hazards in living spaces will be undertaken. In addition to quantifying hazards, the area of living spaces will be obtained to allow the determination of both the number and density (number of hazards per 100 sq ft) of injury hazards. If one or more injury hazards are identified, they will be removed and/or modified to reduce exposure and injury risk. The intervention is focused on areas in living spaces below 1 meter (~39 inches) in height from (the 75th percentile in height or eye-level for a 3-year old US male toddler) which might be easily reached or climbed on by children less than 4 years |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Mothers enrolled in the ECS program who have completed at least one ECS home visit
Key exclusion criteria (6 listed)
- Have a child greater than 5 months of age
- Are non-English speaking
- Live beyond a 3-hr driving radius
- Have plans to relocate outside of a 3-hour driving radius from Cincinnati Children's Hospital in the next 12 months at the time of screening
- Mothers with ECS accounts marked as "Other" such as HMG Part C (having a chronic illness, congenital disorder or developmental delay), HMG At-Risk, first time fathers in Kentucky, etc.
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 |
|---|---|---|
| Injury Intervention GroupThe hazards identified in the home will be reviewed with the parent and the proposed interventions will be presented. Intervention options are designed and prioritized so that the most passive and durable interventions are recommended first (e.g. self-closing, self-locking stair gate) and progressively less 'passive' and less durable options last (e.g. area gate, pressure mounted gate, or refusal of intervention). | Other | Injury Intervention Group |
Primary outcome
Any modifiable and medically-attended injury in enrolled children
Time frame: Quarterly (baseline & annual home visits, quarterly phone surveys) (up to 4 years)
Primary outcome measures will include any phone calls, clinic, and ED visits for falls, cuts/lacerations, contusion/crush, burn/scald, abrasions, and poisoning injuries sustained by enrolled children in the home that were potentially modifiable by the installed safety products. Modifiable injury events are defined as those whose hazard exposure and associated mechanism was potentially modified by the intervention (ie stairgate reducing exposure to a stairway and subsequent stairway fall injury) and include fall, cut/pierce, struck/strike, burn, and poisoning mechanisms.
1 secondary outcome
Correlation of self-reports of non-emergent but medically attended residential injuries in enrolled children.
Time frame: Annually (up to 4 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
- Background: PubMed 19805597Phelan KJ, Khoury J, Xu Y, Lanphear B. Validation of a HOME Injury Survey. Inj Prev. 2009 Oct;15(5):300-6. doi: 10.1136/ip.2008.020958.
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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.
Kieran Phelan, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injury Intervention Group in people with Injury in the Home, run by Children's Hospital Medical Center, Cincinnati 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 1 inclusion and 6 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 11 Dec 2015. 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?
Any modifiable and medically-attended injury in enrolled children (time frame: Quarterly (baseline & annual home visits, quarterly phone surveys) (up to 4 years)). 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 NCT01327092, which also lists 1 linked publication.
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 11 Dec 2015.