ChiPP2: A Trauma-Informed Program for City School Parents (ChiPP2)

June 24, 2024 updated by: Johns Hopkins University
Purpose of this study is to assess the prevalence of adverse childhood experiences (ACEs) and positive childhood experiences (PCEs) among parents enrolled in the Chicago Parent Program (ChiPP) in their child's school and whether those experiences are associated with a) parents' participation in ChiPP and b) program benefits for parents and children.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Purpose of this study is to assess the prevalence of adverse childhood experiences (ACEs) and positive childhood experiences (PCEs) among parents enrolled in the Chicago Parent Program (ChiPP) in their child's school and whether those experiences are associated with a) parents' participation in ChiPP and b) program benefits for parents and children. Parents who enroll in ChiPP groups in their child school are eligible to participate in this study. Data on ACEs, and PCEs are collected at baseline. Parent perceptions of their children's behavior problems and their engagement in early learning are collected at baseline and post-intervention data. Parent satisfaction with ChiPP and their sense of connection with other parents in their ChiPP group are measured at post-intervention only.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
244

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Deborah Ann Gross

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

ChiPP is being offered in 11 Title 1 public schools in Baltimore and targets parents of young children (3-8 years old).

Description

Inclusion Criteria:

  • Parent of child enrolled in Chicago Parent Program group in Baltimore City Public Schools
  • Parent age 18-99
  • Child must be between 3-8 years old

Exclusion Criteria:

  • Parent does not speak English or Spanish

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ChiPP Groups
Parents enroll in Chicago Parent Program groups offered at their child's school
Behavioral: Chicago Parent Program
Chicago Parent Program (ChiPP) is a 12-session group-based parenting skills program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Program participation
Time Frame: immediately after the intervention, approximately 4 months
Number of Chicago Parent Program group sessions attended (range from 0-12 sessions)
immediately after the intervention, approximately 4 months
Parent-reported child behavior frequency using the Eyberg Child Behavior Inventory
Time Frame: change from baseline to immediately after the intervention, approximately 4 months
Parent-reported child behavior problems measured using the Eyberg Child Behavior Inventory. We will measure behavior problem frequency (scores range from 36-252). Higher scores indicate higher frequency.
change from baseline to immediately after the intervention, approximately 4 months
Parent-reported child behavior problems using the Eyberg Child Behavior Inventory
Time Frame: change from baseline to immediately after the intervention, approximately 4 months
Parent-reported child behavior problems measured using the Eyberg Child Behavior Inventory. We will measure whether the parent believes the behavior is a problem (scores range from 0-36). Higher scores indicate more child behavior problems.
change from baseline to immediately after the intervention, approximately 4 months
Parent - Adverse childhood experiences
Time Frame: baseline
number of adverse childhood experiences during parent's first 18 years of life assessed by parent report using the Philadelphia ACEs measure. Number of adverse childhood experiences assessed at baseline only. Includes two sub scales: the Conventional ACE sub scale (15 items measuring adversities in one's home) and the Expanded ACE sub scale (6 items measuring adversities in one's community). Scores can range from 0-21. Higher scores indicate more exposures to childhood adversity
baseline
Parent - Positive childhood experiences
Time Frame: baseline
number of positive childhood experiences during parent's first 18 years of life assessed by parent-report at baseline using the Positive Childhood Experiences scale. Scores can range from 0-7 with higher scores indicating more exposures to positive childhood experiences.
baseline
Parent Satisfaction
Time Frame: immediately after the intervention, approximately 4 months
Parent's satisfaction with the Chicago Parent Program intervention as assessed at post-intervention only and measured using the Chicago Parent Program Parent Satisfaction Form. Measure includes 19 items assessing the extent to which they and their child benefitted from the program (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.
immediately after the intervention, approximately 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Social connectedness
Time Frame: immediately after the intervention, approximately 4 months
parent-reported Likert-type measure of the extent to which parents developed a sense of connection and belonging with the other parents in the Chicago Parent Program intervention group. Measured 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 measuring sense of belonging, quality of the group facilitation, and conflicts among members within the group. Scores can range from 0-5 with higher scores indicating greater social connectedness.
immediately after the intervention, approximately 4 months
Parent engagement in early learning-Teacher Report
Time Frame: change from baseline to immediately after the intervention, approximately 4 months
Measures teacher's perspective on the extent to which parents are engaged in their child's learning. Measured using a teacher-report measure (Teacher-Reported Parent Engagement in Child's Education) adapted from Fast Track measure of parent engagement. Teacher-Reported Parent Engagement in Child's Education includes 5 items assessed rated on a Likert-type scale; scores can range from 5-25 with higher scores indicating greater parent engagement from the perspective of the teacher. Measure completed by teachers.
change from baseline to immediately after the intervention, approximately 4 months
Parent engagement in early learning-Parent Report
Time Frame: change from baseline to immediately after the intervention, approximately 4 months
Measures the extent to which parents perceive they are engaged in their child's learning. Measured using the Parent Engagement in Early Childhood Education (PEECE) Survey. The PEECE Survey includes 25 items rated on a Likert-type scale. Scores can range from 25-100 with higher scores indicating greater engagement in their child's education.
change from baseline to immediately after the intervention, approximately 4 months
Quality of parent participation in the intervention group
Time Frame: immediately after the intervention, approximately 4 months
quality of each parent's participation in the Chicago Parent Program group sessions is assessed by group leaders using the Parent Engagement Rating Scale. This is a 7-item, 4-point Likert-type scale that assesses the extent to which the parent was actively engaged in the group sessions. Scores can range from 7-28 with higher scores indicating greater parent engagement and higher quality of participation in the group sessions.
immediately after the intervention, approximately 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Urban Health Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Deborah Gross, DNSc, Johns Hopkins University

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 17, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00232169

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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