- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06197997
Resilient, Engaged, and Connected Study (REC)
Strengthening Parenting, Young Children's Social-Behavioral Competence, and Kindergarten Readiness in Schools Serving Low-Income Communities
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Deborah Gross, DNSc
- Phone Number: 410-614-5311
- Email: debgross@jhu.edu
Study Contact Backup
- Name: Amie F Bettencourt, PhD
- Phone Number: 410-955-8021
- Email: abetten3@jhu.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Recruiting
- Johns Hopkins School of Nursing
-
Contact:
- Deborah Gross, DNSc
- Phone Number: 410-614-5311
- Email: debgross@jhu.edu
-
Contact:
- Amie Bettencourt, PhD
- Phone Number: 410-955-8021
- Email: abetten3@jhu.edu
-
Principal Investigator:
- Deborah Gross, DNSc
-
Principal Investigator:
- Amie Bettencourt, PhD
-
Baltimore, Maryland, United States, 21205
- Not yet recruiting
- Johns Hopkins University
-
Contact:
- Deborah Gross, DNSc
- Phone Number: 410-614-5311
- Email: debgross@jhu.edu
-
Contact:
- Amie Bettencourt, PhD
- Phone Number: 410-955-8021
- Email: abetten3@jhu.edu
-
Principal Investigator:
- Deborah Gross, DNSc
-
Principal Investigator:
- Amie Bettencourt, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Public school or Community School in Baltimore City, Cecil County, or Harford County serving at least 40% of students meeting eligibility for low-income or located in a community designated as high need by the Maryland State Department of Education based on a score of 0.6 on the Center for Disease Control Social Vulnerability Index:
- has at least 1 full-day public PreK classroom with 20+ students;
- school has not offered CPP in the prior 3 years;
- principal consents to being randomized and participate for 2 years;
- principal consents to study team recruiting parents, teachers, and staff to participate in the study.
PreK Parents:
- Parent (biological, step, adoptive, foster), grandparent, or legal guardian of 4-5 year old student enrolled in participating PreK program;
- 18+ yrs;
- speaks English or Spanish;
- consents to allowing access child's school identification.
Teachers:
- PreK or K teacher in classroom of student of participating parent;
- consents to completing study surveys.
CPP Group Leaders:
- completes CPP group leader training
- agrees to lead CPP groups
- speaks English or Spanish
- at least a High School diploma/General Equivalency Diploma (GED)
- consents to completing surveys and submitting audio recorded CPP sessions for fidelity assessment
School-based personnel inclusion criteria:
- Principal, teacher, or other school-based staff involved in CPP implementation
- consents to interview on perspectives about CPP in the school
Exclusion Criteria:
- Principal cannot commit staff to offering CPP groups
- school previously offered CPP in prior 3 years
- school located in a geographic area with less than 80% connectivity
- PreK Parents previously participated in CPP
- Teachers: teacher also a participating parent or CPP group leader
- School-based personnel: Principal, teacher, or other school-based staff is a study parent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Title 1 schools receive the Chicago Parent Program intervention
The experimental group from Title 1 or Community Schools across two Maryland school districts (Baltimore City Public Schools and Cecil County Public Schools) will receive the Chicago Parent Program intervention.
|
The Chicago Parent Program (CPP) is a 12-session group-based parenting intervention designed to strengthen parenting skills and parent engagement in children's learning and improve children's social-emotional and behavioral competence.
|
|
No Intervention: Title 1 schools receive the usual school practice
The control group from Title 1 or Community Schools across two Maryland school districts (Baltimore City Public Schools and Cecil County Public Schools) will receive the usual school practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social-behavioral readiness as assessed by the social-behavioral domain of the Kindergarten Readiness Assessment (KRA).
Time Frame: 1-year follow-up
|
School district's measure of children's social-behavioral readiness to learn at kindergarten entry.
Kindergarten Readiness Assessment (KRA) assesses 4 domains of readiness.
Domain scores range from 202-298.
Higher score is a better outcome.
|
1-year follow-up
|
|
Percentage of children who reported chronic absence
Time Frame: 1 year
|
Percent of children missing 10% or more school days during the kindergarten year.
Data will be collected on number of days the school district records the students as absent from school.
|
1 year
|
|
Percentage of children who retained in grade
Time Frame: 1 year
|
Percentage of children retained in kindergarten for another year.
Data will be collected based on report from the school district on whether child was retained.
|
1 year
|
|
Social Competence and Behavior Evaluation (SCBE-30) score (Teacher Version)
Time Frame: Baseline, post-intervention up to 4 months, post-intervention up to 8 months, 1-year follow-up
|
change in measures of children's behavior and social-emotional skills from perspective of teachers.
Teachers complete the Social Competence and Behavior Evaluation (SCBE-30).
Teacher version contains 3 sub scales of 10 items each.
Subscale scores range from 10- 60.
Higher scores indicate higher levels of social competence.
|
Baseline, post-intervention up to 4 months, post-intervention up to 8 months, 1-year follow-up
|
|
Social Competence and Behavior Evaluation (SCBE-30) score (Parent Version)
Time Frame: Baseline, post-intervention up to 4 months, post-intervention up to 8 months, 1-year follow-up
|
change in measures of children's behavior and social-emotional skills from perspective of parents.
Parent version of the SCBE-30 contains 3 sub scales of 10 items each.
Subscale scores range from 10- 60.
Higher scores indicate higher levels of social competence.
|
Baseline, post-intervention up to 4 months, post-intervention up to 8 months, 1-year follow-up
|
|
Eyberg Child Behavior Inventory (ECBI) score
Time Frame: Baseline, post-intervention up to 4 months, post-intervention up to 8 months, 1-year follow-up
|
change in child behavior problems on the Eyberg Child Behavior Inventory (ECBI) ECBI contains two sub scales of 36 items each; Intensity Scale scores can range from 36-252; Problem Scale scores can range from 0-36.
Higher scores indicate worse outcomes.
|
Baseline, post-intervention up to 4 months, post-intervention up to 8 months, 1-year follow-up
|
|
Parent engagement as assessed by the Parent-Teacher Involvement Questionnaire
Time Frame: Baseline, post-intervention up to 4 months, post-intervention up to 8 months, 1-year follow-up
|
change in measures of parent's engagement in their children's early education from the perspective of teachers.
Teachers will compete a 7-item measure of parent engagement from the Parent-Teacher Involvement Questionnaire.
Scores range from 7-35.
Higher scores indicate more parental involvement.
|
Baseline, post-intervention up to 4 months, post-intervention up to 8 months, 1-year follow-up
|
|
Parent engagement as assessed by the Parent Engagement in Early Childhood Education (PEECE) Survey
Time Frame: Baseline, post-intervention up to 4 months, post-intervention up to 8 months, 1-year follow-up
|
change in measure of parent engagement on the Parent Engagement in Early Childhood Education (PEECE) Survey, a 25-item measure of parent engagement.
Scores can range from 25-100.
Higher scores indicate higher involvement.
|
Baseline, post-intervention up to 4 months, post-intervention up to 8 months, 1-year follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total kindergarten readiness score
Time Frame: 1 year
|
Total kindergarten readiness score as assessed by the Kindergarten Readiness Assessment including language/literacy, numeracy skills, physical well-being/motor development, and social-behavioral readiness.
Administered by and calculated by the school district.
|
1 year
|
|
Parenting skills as assessed by the Parenting Questionnaire
Time Frame: Baseline, post-intervention up to 3 months, 1-year follow-up
|
change in parenting skills measured by the Parenting Questionnaire a measure of parents' use of positive discipline, harsh discipline, and consistency of discipline techniques.
The score ranges from 40-200.
There are 3 subscales of interest for the parenting questionnaire that include: (1) Warmth: higher scores = greater warmth; (2) Corporal Punishment: higher scores = greater use of corporal punishment, and (3) Following Through on Discipline: higher scores = more likely to follow through on discipline.
|
Baseline, post-intervention up to 3 months, 1-year follow-up
|
|
Social connectedness as assessed by Intervention Group Environment Scale
Time Frame: post-intervention up to 4 months
|
Measures parents' sense of belonging and connection with the school, using the 25-item Intervention Group Environment Scale and items are measured along a 5-point continuum of strongly disagree to strongly agree.
Includes 3 sub scales.
Scores can range from 0-5 with higher scores indicating greater social connectedness.
|
post-intervention up to 4 months
|
|
Parent Satisfaction as assessed by the Chicago Parent Program Satisfaction form
Time Frame: Post-intervention up to 4 months
|
Measured using the Chicago Parent Program Parent Satisfaction Form.
The survey Includes 16 items.
Scored on a Likert-type scale, aspects of the program that were most and least beneficial, and the extent to which the participant would recommend the program to other parents.
Each item is scored and interpreted separately.
|
Post-intervention up to 4 months
|
|
CPP Reach as assessed by percent of eligible parents enrolled
Time Frame: At baseline
|
CPP Reach is defined by parent participation in CPP and will be measured by percent of eligible parents enrolled.
|
At baseline
|
|
CPP Effectiveness as assessed by End of Program Satisfaction score
Time Frame: Immediately post intervention
|
Parents will complete the End of Program Satisfaction Form at post-intervention to assess their satisfaction of the extent to which CPP improved their parenting skills, their children's behavior, their confidence in supporting their children's school success; supported their relationships with their children's teacher and school; created challenges for participation (including technology challenges for virtual groups and transportation challenges for in person groups); and their overall satisfaction with CPP. 8 questions on a 4-point scale, 8 questions on a 3 point scale, and 4 open questions.
Each item analyzed separately, higher scores indicate higher satisfaction.
|
Immediately post intervention
|
|
CPP Perceived effectiveness as assessed by qualitative interview
Time Frame: Immediately post-intervention (intervention group)
|
Perceived effectiveness will also be assessed from interviews with principals, school staff, and CPP group leaders (approximately 4 total individuals from each school) to understand their perceptions of CPP's benefits and limitations.
|
Immediately post-intervention (intervention group)
|
|
CPP Adoption as assessed by qualitative interview
Time Frame: Immediately post-intervention (intervention group)
|
CPP Adoption will be assessed from interviews with school staff involved in CPP implementation (i.e., CPP group leaders, school leadership - approximately 4 total individuals from each school) to understand whether and how CPP was folded into their normal workflow; perceived benefits and challenges with offering virtual versus in-person CPP; what the participant learned over the course of the two years of implementation; whether the participant would want to adopt CPP at their school and why; and if CPP were to continue at their school, what the participant believes is needed to make CPP work well for the participant.
|
Immediately post-intervention (intervention group)
|
|
Percentage of CPP group-leader retention rate
Time Frame: 2 years
|
The investigators will collect data on group leader retention over two years
|
2 years
|
|
CPP Implementation challenges as assessed by qualitative interview
Time Frame: 2 years
|
Differences in implementation challenges by rural versus urban school districts (e.g.
travel distance to school, space in schools) and virtual versus in person groups (e.g.
ease of internet access, space in schools).
|
2 years
|
|
Social Connectedness in Group Environments Scale (Parent)
Time Frame: Immediately post-intervention (intervention group)
|
Parent data will include CPP parent ratings of social connectedness formed within their group as measured by the Social Connectedness in Group Environments Scale.
This is a 25-item parent report survey with 3 subscales measuring parents' perceptions of cohesion and sense of belonging among group members, extent to which group leaders generated a positive group environment and negative interactions among group members.
Items are scored on a 5-point scale of strongly agree to strongly disagree.
Score range 25-125.
Higher score greater social connectedness.
|
Immediately post-intervention (intervention group)
|
|
Percentage of parents who completed CPP
Time Frame: Immediately post-intervention (intervention group)
|
CPP dose (number of sessions attended and CPP practice assignments completed) will be collected based on the session reports.
|
Immediately post-intervention (intervention group)
|
|
Quality of Parents' Participation in the CPP groups as assessed by the Quality of Participation score
Time Frame: Immediately post-intervention (intervention group)
|
This will be assessed after the 11th session by group leaders using the Quality of Participation Form (QPF).
The QPF is a 7-item group-leader report of the extent to which parents are actively engaged in the group sessions supportive to other members in the group, open to trying to new strategies, and able to correctly apply program principles, and quality of parent participation in the CPP groups.
Items are rated from 1 (not at all) to 4 (most of the time) and summed.
Score range 7-28, higher score better quality.
|
Immediately post-intervention (intervention group)
|
|
CPP Implementation Quality as assessed by CPP Fidelity Checklist score
Time Frame: Up to 12 weeks
|
This will be assessed by independent raters from a random selection of three audio-recorded CPP sessions per 12-session group using the CPP Fidelity Checklist developed by the study team members.
The CPP Fidelity Checklist assesses group leader competence (skill) and adherence to the protocol.
For competence, there are 16 items (score range 1-3).
For adherence, there are 12-14 items scored yes/no, and the score ranges from 0 to 100 percent adherence.
Higher scores indicates better fidelity adherence.
|
Up to 12 weeks
|
|
Maintenance of CPP as assessed by implementation costs
Time Frame: Immediately post-intervention (intervention group)
|
Maintenance is defined as the likelihood of schools being able to sustain CPP.
Data will include CPP implementation costs of in-person versus virtual CPP groups (including the Conditional Cash Transfers for participating in the CPP groups).
|
Immediately post-intervention (intervention group)
|
|
Maintenance of CPP as assessed by qualitative interview
Time Frame: Immediately post-intervention (intervention group)
|
Maintenance is defined as the perceived likelihood of schools being able to sustain CPP based on the interviews with school-based staff (approximately 4 total individuals from each school).
|
Immediately post-intervention (intervention group)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cost-effectiveness
Time Frame: Post-intervention up to 3 months
|
Cost of the intervention will be estimated using incremental cost effectiveness ratios.
|
Post-intervention up to 3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Deborah Gross, DNSc, JHU School Of Nursing
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Other Study ID Numbers
- IRB00428221
- 1R01HD108160-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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