- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04089020
Walking to School Supports
Psychosocial Supports for Walking to School Paired With a Walking School Bus
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
Kansas City, Missouri, United States, 64108
- Children's Mercy Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Parents of children enrolled at Benjamin Banneker school
- Parents/child dyads who completed the Phase 1 survey OR respond to recruitment attempts and express interest in walking to school. Included parent/child dyads will be:
Those who do not participate in LINC program both before and after school 4+ days per week (child); Those who live within the school boundary and south of Meyer Blvd (i.e., close enough to an existing walking school bus route) or are willing to drop off and/or pick up the child at a place along an existing walking school bus route (i.e., remote drop off).
Exclusion Criteria:
- Children not enrolled at Benjamin Banneker school
- Those who participate in LINC program both before and after school 4+ days per week (child); Those who do not live within the school boundary and south of Meyer Blvd (i.e., close enough to an existing walking school bus route) or are not willing to drop off and/or pick up the child at a place along an existing walking school bus route (i.e., remote drop off).
- We will exclude each of the following special populations:
Adults unable to consent Prisoners Wards of the state Pregnant women may be included, but only in such capacity as parents of other children enrolled at Benjamin Banneker school
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Psychosocial intervention
Text messaging and health coaching over the telephone to address goal setting, monitoring, motivation, problem solving, and related skills, delivered over 6 weeks.
|
5 modules that address psychosocial skills, with ongoing text messaging.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of Intervention: "Satisfaction Questionnaire"
Time Frame: at 6 weeks, immediately after completion of the intervention
|
Acceptability and preferences related to intervention content will be measured using a questionnaire developed for this study ("satisfaction questionnaire").
Families (both parent and child responding together) will respond to 5 items asking about satisfaction with the intervention components.
Items are rated on a 10-pt scale (minimum:1- maximum:10), with higher values indicating greater satisfaction.
They will respond to two additional open-ended questions asking which aspects of the intervention they liked most and least.
These qualitative items will be summarized.
|
at 6 weeks, immediately after completion of the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of Walking to School
Time Frame: up to 6 weeks
|
Number of walking trips to/from school per week (0 to 10) will be assessed using a daily (Mon-Fri) tracking questionnaire completed through RedCap.
|
up to 6 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jordan Carlson, PhD, Children's Mercy Hospital Kansas City
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00000851
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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