- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06197997
Resilient, Engaged, and Connected Study (REC)
January 8, 2024 updated by: Johns Hopkins University
Strengthening Parenting, Young Children's Social-Behavioral Competence, and Kindergarten Readiness in Schools Serving Low-Income Communities
Purpose of this study is to test the effectiveness and implementation of an evidence-based parenting intervention for improving parenting and school outcomes in a sample of 4-year-old children enrolled in public prekindergarten (PreK) programs in Maryland.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Using a hybrid Type 2 effectiveness-implementation design, this study tests the effectiveness and implementation of an evidence-based parenting intervention for improving parenting and school outcomes in a sample of 4-year-old children enrolled in public prekindergarten (PreK) programs in Maryland.
Thirty Title 1 schools across two Maryland school districts (Baltimore City Public Schools n=20; Cecil County Public Schools n=10) will be randomized into experimental (receive the Chicago Parent Program intervention) or control (usual school practice) conditions.
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.
All schools will participate for 2 years.
In the experimental condition, school staff trained in CPP will implement the program in groups of 10-15 parents of PreK students in a virtual group or in-person group format (format order counterbalanced).
Parents in the control condition will complete surveys only.
Study outcomes for all participants will be evaluated at PreK baseline (T1), 4-5 months post baseline (T2), in the fall of kindergarten (T3), and at the end of kindergarten (T4).
Outcomes include children's social-emotional-behavioral competence, parent engagement in early childhood education, and parenting skills; school community cohesion; kindergarten readiness, chronic absence, and retained in kindergarten.
Additional evaluation data will be collected in the experimental condition assessing perceived effectiveness, implementation quality, uptake, and cost-effectiveness to understand factors that affect the likelihood the program can be successfully integrated and sustained in urban and rural school settings.
Study Type
Interventional
Enrollment (Estimated)
840
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
- 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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Title 1 public schools in Cecil County or Baltimore City:
- has at least 1 full-day public PreK classroom with 20+ students;
- 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 year old student enrolled in participating PreK program;
- 18+ yrs;
- speaks English or Spanish;
- access to broadband Internet and Internet device;
- 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:
- Title 1 public schools in Cecil County or Baltimore City:
- Principal cannot commit staff to offering CPP groups
- school previously offered CPP
- school located in a geographic area with 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 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 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 Competence and Behavior Evaluation (SCBE-30) score (Teacher Version)
Time Frame: Baseline, post-intervention up to 3 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 3 months, 1-year follow-up
|
Social Competence and Behavior Evaluation (SCBE-30) score (Parent Version)
Time Frame: Baseline, post-intervention up to 3 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 3 months, 1-year follow-up
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Eyberg Child Behavior Inventory (ECBI) score
Time Frame: Baseline, post-intervention up to 3 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 3 months, 1-year follow-up
|
Parent engagement as assessed by the Parent-Teacher Involvement Questionnaire
Time Frame: Baseline, post-intervention up to 3 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 3 months, 1-year follow-up
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Parent engagement as assessed by the Parent Engagement in Early Childhood Education (PEECE) Survey
Time Frame: Baseline, post-intervention up to 3 months, 1-year follow-up
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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 3 months, 1-year follow-up
|
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
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Percentage of children who reported chronic absence
Time Frame: 1 year
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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.
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1 year
|
Percentage of children who retained in grade
Time Frame: 1 year
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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.
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1 year
|
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
|
Social connectedness as assessed by Intervention Group Environment Scale
Time Frame: post-intervention up to 3 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.
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post-intervention up to 3 months
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Parent Satisfaction as assessed by the Chicago Parent Program Satisfaction form
Time Frame: Post-intervention up to 3 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 they would recommend the program to other parents.
Each item is scored and interpreted separately.
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Post-intervention up to 3 months
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Parenting skills as assessed by the Parenting Questionnaire
Time Frame: Baseline, post-intervention up to 3 months, 1-year follow-up
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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.
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Baseline, post-intervention up to 3 months, 1-year follow-up
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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
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Deborah Gross, DNSc, JHU School Of Nursing
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2024
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2028
Study Registration Dates
First Submitted
December 7, 2023
First Submitted That Met QC Criteria
January 8, 2024
First Posted (Actual)
January 10, 2024
Study Record Updates
Last Update Posted (Actual)
January 10, 2024
Last Update Submitted That Met QC Criteria
January 8, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00406337
- 1R01HD108160-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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