Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03517475
Other study ID # AD3874920
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date August 31, 2023

Study information

Verified date May 2023
Source Western Michigan University
Contact Amy Damashek
Phone 2693874920
Email Amy.Damashek@wmich.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators will pilot test (N=100 caregivers of children ages 3-4 years) the effects of a caregiver supervision intervention on caregivers' supervision and children's injury frequency using a Randomized Controlled Trial (RCT) design. The control group will receive Services as Usual (SAU), and the treatment group will receive SAU+ SHS. The results will be used to support an R01 application to conduct a larger-scale RCT test of the program.


Description:

For the RCT, the investigators will recruit Head Start participants with help from the home visitors (using procedures that are similar to phase 1 recruitment procedures). The home visitors will read a short script about the study to eligible clients; it will be emphasized that the Head Start services they receive will not be impacted by their decision about whether or not to participate. Interested caregivers will sign a release form for the home visitors to provide the caregiver's contact information to study personnel. A Graduate Research Assistant (GRA) will then call the caregivers and will read a recruitment script. If the caregiver is interested in participating, the GRA will set up a meeting in the caregiver's home to complete consent and baseline measures. Caregivers will be eligible to participate if they are the primary caregiver (male or female) for at least one child in the target age range (3-4 years-of-age), the caregiver can speak and read English, and the caregiver did not participate in the focus group study. The investigators will exclude families in which the target child has been diagnosed with a pervasive developmental disorder or is blind or deaf because such conditions often result in specialized supervision requirements, and the investigators have not tailored the intervention to be appropriate for such families. Later research may examine whether the intervention or a modified version of it, is appropriate for such families. If there is more than one child in the home who is attending Head Start and is between the ages of 3-4 years, the investigators will use a random procedure to choose the target child. Participants who consent will be randomly assigned to either the treatment or control condition by the primary investigator after the consent appointment. A blinded design will be used so the GRA who will collect data will not know who is in the treatment group. A GRA and URA will administer baseline, post-test, and follow-up assessments at participants' homes. Baseline assessments will include three self-report measures of caregiver supervision beliefs and practices, a measure of caregivers' injury beliefs, and a measure of children's injury history. The investigators will also conduct an observation of in-home supervision and collect data on current injuries. The baseline, post, and follow-up sessions will take approximately one hour. If needed, the GRA will assist caregivers with low literacy to complete the measures by reading the measures aloud or by answering questions about the measures. The investigators have used this approach successfully in previous studies (Damashek & Corlis, 2017; Damashek, Hughes, Chahin, & Corlis, 2017). After the baseline session, primary caregivers randomized to the treatment condition will participate in one-hour intervention sessions in their home for 5 weeks. Those randomized to the treatment group will receive the tailored SHS intervention in addition to their Head Start home visiting services (SHS+SAU); those randomized to the control group will only receive the Head Start home visiting services (SAU). A GRA will deliver the intervention to the treatment group and will be assisted by an Undergraduate Research Assistant (URA). The GRA will be trained by the co-investigator to deliver SHS and will use a manual to guide delivery (based on previous work, Morrongiello et al., 2017). A week after the last intervention session (or an equivalent time period for the control group), the GRA and URA will return to the participant's home and will re-administer the same measures taken at baseline, in addition to questionnaires assessing their satisfaction with the intervention and perception of the intervention's cultural acceptability. The investigators will conduct a 1-month follow-up to assess for sustainability of effects during which the investigators will administer the same supervision and injury measures as at baseline. In addition to self-report measures, the investigators will conduct pre-, post-, and follow-up observational assessments of maternal supervision, based on an innovative testing protocol developed by Morrongiello and her colleagues (Morrongiello, McArthur, Goodman, & Bell, 2015). During the data collection appointments, the investigators will set up a situation in which the investigators will observe caregivers' supervision of their child while they are distracted and while their child is exposed to an interesting and potentially hazardous object (a "gadget", see Measures). The investigators will also collect data on children's minor everyday injury frequencies using a structured injury interview that will be administered weekly via telephone; this measure has been used in previous research by the PI (Damashek & Corlis, 2017). The first interview will be administered in person during the baseline data collection session. A second baseline injury interview will occur 1 week before caregivers participate in their first intervention session. Additional administrations will occur weekly via telephone through the follow-up data collection appointment.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date August 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Caregivers will be eligible to participate if they are the primary caregiver (male or female) for at least one child in the target age range (3-4 years-of-age), the caregiver can speak and read English, and the caregiver did not participate in the focus group study. Exclusion Criteria: - We will exclude families in which the target child has been diagnosed with a pervasive developmental disorder or is blind or deaf.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
SHS Low-Income
An intervention to train caregivers to supervise their children appropriately.

Locations

Country Name City State
United States Western Michigan University Kalamazoo Michigan

Sponsors (2)

Lead Sponsor Collaborator
Western Michigan University University of Guelph

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Supervision levels 11 weeks
Secondary Injury Frequency 11 weeks
See also
  Status Clinical Trial Phase
Completed NCT03285009 - Movement Patterns in Young Volleyball Athletes N/A
Recruiting NCT05487768 - Functional Connectivity After Anterior Cruciate Ligament Reconstruction N/A
Not yet recruiting NCT06195631 - Evaluating a Standardized Checklist Bundle for Optimizing Procedural Ergonomics in Endoscopy N/A
Completed NCT02329340 - Safety Skills Training: Parents of School-Aged Children Phase 2
Not yet recruiting NCT05529017 - Post Injury Performance Deficits in Rink Hockey
Recruiting NCT05910515 - Improving Performance in Pediatric Trauma by Teaching Nontechnical Skills N/A
Completed NCT04096196 - A Game-based Educational Approach to Promote Child Safety Knowledge and Behaviours N/A
Completed NCT06264323 - Incidence of Acute Injuries in Boxing
Completed NCT06039358 - Effects of Caffeine Ingestion on the Biomechanics of Healthy Young Subjects N/A
Recruiting NCT05394363 - Generation Victoria Cohort 2020s: A Statewide Longitudinal Cohort Study of Victorian Children and Their Parents
Recruiting NCT06092866 - Digital Versus Telephone Symptom Assessment and Triage in Primary Care N/A
Not yet recruiting NCT05549830 - Effect of Different Positioning Before, During and After Surgery on Pressure Injury N/A
Active, not recruiting NCT00852085 - Reducing Youthful Dangerous Driving Phase 1/Phase 2
Completed NCT05552430 - Virtual Reality for Pain in Acute Orthopedic Injuries N/A
Not yet recruiting NCT06302088 - The Safety Integration Stakeholders (SAINTS) Program to Integrate Worker and Patient Safety in Oregon Rural Hospitals N/A
Completed NCT03108820 - Trauma Medical Home for Older Injured Patients N/A
Active, not recruiting NCT05629156 - Injury and Illness Surveillance at the FIFA World Cup Qatar 2022TM
Completed NCT05121649 - Video-instructed First Aid in Emergency Medical Call Centers
Active, not recruiting NCT04469036 - Improving Family-Centered Pediatric Trauma Care: The Standard of Care Versus the Virtual Pediatric Trauma Center N/A
Completed NCT04103437 - Evaluation of Harmonicity in Running Gait by the Use of Innovative Techniques of Video Analysis