Parenting for Tomorrow: A New Model for Supporting Preschool Children's Mental Health in Head Start

December 11, 2025 updated by: Johns Hopkins University
Purpose of this study is to test the preliminary efficacy, acceptability, accessibility, cost, and sustainability of an innovative mental health treatment model for young children from low-income, under-resourced communities through a partnership with Head Start programs in urban and rural communities in Maryland.

Study Overview

Status

Status

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

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

The purpose of the study is to test the preliminary efficacy, acceptability, accessibility, cost, and sustainability of an innovative, scalable model for improving young children's mental health services through a partnership with Head Start programs in urban and rural communities in Maryland. The study will use four transformational innovations for eliminating barriers to high quality mental health services for families of young children (2-5 years old) from low-income, under-resourced communities through a partnership with Head Start programs in urban and rural communities in Maryland: 1) test an adaptation of a validated group-based parenting skills and support program (Chicago Parent Program) developed in collaboration with African American and Hispanic parents from low-income communities, for use with individual families (CPPi) concerned about the participant's preschool children's mental health; 2) embed CPPi in a trusted community-based agency long committed to a 2-generation social service model of supporting families from low-income communities; 3) use human centered design strategies to co-create a CPPi referral and enrollment strategy with parents and staff that is welcoming, culturally appropriate, consistent with Head Start's service delivery processes, and eliminates the stigma associated with children receiving a psychiatric diagnosis (as is typically required for reimbursement in traditional child mental health settings); and 4) capitalize on the knowledge, experience, and holistic orientation of registered nurses (RNs) to implement CPPi in Head Start. Children's behavior problems collected at baseline and post-intervention data from the parent and teacher's perspectives. Parent satisfaction with CPPi is 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 (Estimated)

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.
160

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Amie F Bettencourt, PhD
  • Phone Number: 410-955-8021
  • Email: abetten3@jhu.edu

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • Johns Hopkins University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Parents (defined broadly to include a range of caregivers) of young children (2-5 years old) in Head Start programs in urban and rural communities in Maryland.

Description

Inclusion Criteria:

  • Child is 2-5 years old, enrolled in Baltimore City Head Start (Baltimore City Mayor's Office on Child & Family Success) or Head Start sites managed by Catholic Charities of MD
  • parent expresses concern about the child's behavior or need for parenting support
  • parent speaks English or Spanish
  • Parent age 18-99 years
  • Parent able to participate in virtual intervention sessions

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.
Parents enroll in Parenting for Tomorrow using Chicago Parent Program - individualized for families
Parents enroll in Parenting for Tomorrow using Chicago Parent Program - individualized for families (CPPi) implemented through a telehealth approach.
Behavioral: Chicago Parent Program - individualized for families (CPPi)
CPPi is a 8-12 session individual- 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
Change in Child Social - Emotional and Behavioral Wellbeing as assessed by the Strength & Difficulties Questionnaire (SDQ)
Time Frame: Baseline, immediately after the intervention
Strength & Difficulties Questionnaire (SDQ), a 25 item measure of children's emotional symptoms (5 items), conduct problems (5 items), hyperactivity/inattention (5 items), peer relationship problems (5 items) and prosocial behavior (5 items). A higher score on the SDQ's emotional symptoms, conduct problems, hyperactivity/inattention, and peer relationship problems scales generally indicates more difficulties in those areas, while a lower score suggests fewer problems. Conversely, a higher score on the prosocial behavior scales indicates more positive social behaviors, while a lower score suggests more difficulties in this area. The score range for total difficulties is 0-40 and the score range for prosocial behavior is 0-10.
Baseline, immediately after the intervention
Change in Child Anxiety as assessed by the Preschool Anxiety Scale (PAS)
Time Frame: Baseline, immediately after the intervention
Preschool Anxiety Scale (PAS), a 28-item measure of young children's generalized, social, and separation anxieties; obsessive compulsive disorder, and physical injury fears. The score ranges from 0 - 112. Elevated scores on specific subscales may be indicative of potential concerns in those areas.
Baseline, immediately after the intervention
Change in Child Social - Emotional and Behavioral Wellbeing in the Classroom as assessed by the Social Competence and Behavior Evaluation (SCBE)
Time Frame: Baseline, immediately after the intervention
Head Start teacher ratings of children's social competence and behavior in the classroom using the Social Competence and Behavior Evaluation (SCBE), a 30-item measure with 3 subscales measuring children's social competence, anger/aggression, and anxiety/withdrawal. The score ranges from 30-180. A higher score on the social competence subscale suggests that the child displays more positive social behaviors and skills. A higher score on the anger/aggression subscale suggests that the child exhibits more anger and aggressive behaviors. A higher score on the anxiety/withdrawal subscale suggests that the child experiences more anxiety and withdrawal behaviors.
Baseline, immediately after the intervention
Change in parenting skills as assessed by the Parenting Questionnaire (PQ)
Time Frame: Baseline, immediately after the intervention
Parenting Questionnaire (PQ) is a validated 40-item 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, immediately after the intervention
Change in parenting confidence as assessed by the Parenting Sense of Competence Scale (PSOC)
Time Frame: Baseline, immediately after the intervention
Parenting Sense of Competence Scale (PSOC) is a widely used 17-item measure of parents' confidence with managing their child's behavior. The score ranges from 17-102. A higher score indicates a higher parenting sense of competency.
Baseline, immediately after the intervention
Number of referred children with clinically significant social-emotional and behavioral scores as assessed by a survey developed by the study team
Time Frame: Immediately after the intervention
CPPi accessibility will be assessed by collecting information on the number of referred children with clinically significant Social-emotional and behavioral scores. Data will be obtained from CPPi RNs who will document all service encounters.
Immediately after the intervention
Length of time (in days) from referral to first CPPi appointment as assessed by a survey developed by the study team
Time Frame: Immediately after the intervention
CPPi accessibility will also be assessed by collecting information on the length of time (in days) from referral to first CPPi appointment. Data will be obtained from CPPi RNs who will document all service encounters.
Immediately after the intervention
Number of referred families who initiate CPPi treatment as assessed by a survey developed by the study team
Time Frame: Immediately after the intervention
CPPi accessibility will also be assessed by collecting information on the number of referred families who initiate CPPi treatment. Data will be obtained from CPPi RNs who will document all service encounters.
Immediately after the intervention
Average attendance by parents to scheduled CPPi sessions as assessed by a survey developed by the study team
Time Frame: Immediately after the intervention
CPPi accessibility will also be assessed by collecting information on average attendance by parents to scheduled CPPi sessions. CPPi includes 6 required and 2 optional modules, and parents are expected to attend 8-12 1-hour sessions to complete CPPi. Data will be obtained from CPPi RNs who will document all service encounters.
Immediately after the intervention
Number of CPPi modules completed as assessed by a survey developed by the study team
Time Frame: Immediately after the intervention
CPPi accessibility will also be assessed by collecting information on the number of CPPi modules completed. CPPi includes 6 required and 2 optional modules. CPPi includes 6 required and 2 optional modules. Data will be obtained from CPPi RNs who will document all service encounters.
Immediately after the intervention
Number of parents completing CPPi as assessed by a survey developed by the study team
Time Frame: Immediately after the intervention
CPPi accessibility will also be assessed by collecting information on the number of parents completing CPPi. CPPi includes 6 required and 2 optional modules. Data will be obtained from CPPi RNs who will document all service encounters.
Immediately after the intervention
Number of missed appointments without cancellation for CPPi sessions as assessed by a survey developed by the study team
Time Frame: Immediately after the intervention
CPPi accessibility will also be assessed by collecting information on the number of missed appointments without cancellation for CPPi sessions. Data will be obtained from CPPi RNs who will document all service encounters.
Immediately after the intervention
Number of internet connectivity issues experienced during CPPi sessions as assessed by a survey developed by the study team
Time Frame: Immediately after the intervention
CPPi accessibility will also be assessed by collecting information on the number of internet connectivity issues experienced. Data will be obtained from CPPi RNs who will document all service encounters.
Immediately after the intervention
Percentage of improvement in participants' perceived effectiveness of CPPi as assessed by a survey developed by the study team
Time Frame: Immediately after the intervention
The CPPi acceptability will be assessed by measuring the impact of CPPi on participants' perceived efficacy.
Immediately after the intervention
Percentage of participants reporting satisfaction with the CPPi referral, scheduling process, and virtual format as assessed by a survey developed by the study team.
Time Frame: Immediately after the intervention
The CPPi acceptability will also be assessed by measuring the referral, scheduling process, and virtual format for CPPi sessions.
Immediately after the intervention
Percentage of participants rating CPPi as user-friendly as assessed by a survey developed by the study team.
Time Frame: Immediately after the intervention
The CPPi acceptability will also be assessed by measuring the ease of use of the intervention program. Data will be collected from parents and RNs who were involved in the program.
Immediately after the intervention
Participants' ratings of the quality of therapeutic relationship with CPPi nurses as assessed by a survey developed by the study team.
Time Frame: Immediately after the intervention
The CPPi acceptability will also be assessed by measuring the quality of therapeutic relationship between parents and the CPPi nurses.
Immediately after the intervention
Parent's satisfaction as assessed by a survey developed by the study team
Time Frame: Immediately after the intervention
Parent's satisfaction will be 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. The score for the first seven questions ranges from 7-28, with a higher score indicating higher satisfaction with the program. For question number 10-16, the score ranges from 7-28, and higher score indicates that the program was very helpful.
Immediately after the intervention
CPPi sustainability as assessed by a survey developed by the study team
Time Frame: Immediately after the intervention
The CPPi sustainability will be measured using interviews that will be conducted with Head Start teachers, family service workers, and agency leaders (n=20) to learn their perceptions of the benefits and limitations of implementing CPPi with their families, extent to which they believe CPPi improved child mental health and contributed to their mission, anticipated barriers and facilitators to sustaining CPPi, and recommendations for future implementation. We will also interview up to 5 CPPi Registered Nurses to learn their perceptions of how CPPi and working with Head Start parents fit with their knowledge, expertise, and career goals and barriers and facilitators to continuing this work after the study ends.
Immediately after the intervention
Implementation cost as assessed by a survey developed by the study team
Time Frame: Immediately after the intervention
The study will estimate CPPi implementation costs including direct (CPPi materials, provider training, referral costs, RN time to prepare for and implement CPPi sessions, RN supervision costs, costs to parents and RN's associated with use of their computer hardware or cellphone and broadband connection, technical problems resulting in additional costs) and indirect (e.g., parent time) costs. Data will come from study records and participant interviews. Costs will be calculated by multiplying the quantity of each source used by the resource's cost per unit, then summing up all of the resources. Person time costs will be estimated using national US Bureau of Labor Statistics mean hourly compensation cost estimates for RNs including salary and fringe benefits. Costs for use of computer equipment and broadband will be estimated based on national average broadband costs per hour allocated to each CPPi participant and RN proportionally based on time in sessions.
Immediately after the intervention
Percent of CPPi nurses who adhere to the CPPi program as assessed by a survey developed by the study team
Time Frame: Immediately after the intervention
All CPPi sessions will be audio recorded (with parent consent) and submitted to the Project Director. A random selection of 10% of audio recordings will be assessed for CPPi Fidelity (RN adherence to the CPPi protocol and facilitation skill/quality).
Immediately after the intervention
Number of CPPi sessions attended by the parents as assessed by a survey developed by the study team
Time Frame: Immediately after the intervention
The CPPi Program participation ranges from 0-12 sessions.
Immediately after the intervention

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
Change in parental mental health - anxiety as assessed by the Generalized Anxiety Disorder Scale (GAD-7)
Time Frame: Baseline, immediately after the intervention
Generalized Anxiety Disorder Scale (GAD-7) is a 7-item screening measure of generalized anxiety. The score ranges from 0-21. A score of 0-4: indicates minimal anxiety, 5-9 indicates mild anxiety, 10-14 indicates moderate anxiety, and 15-21 indicates severe anxiety.
Baseline, immediately after the intervention
Change in parental mental health - depressive symptoms as assessed by the Patient Health Questionnaire-Depression Scale (PHQ-8)
Time Frame: Baseline, immediately after the intervention
Patient Health Questionnaire-Depression Scale (PHQ-8) is a brief measure of depressive symptoms in the general population. The score ranges 0-24. A score of 10 or greater is considered major depression, 20 or more is severe major depression.
Baseline, immediately after the intervention

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.
The Rita and Alex Hillman Foundation
Abell Foundation
Richman Foundation
Sherman Family Foundation
Blanket Fort Foundation
Wright Family Foundation
Baltimore Community Foundation

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, 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 (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.
November 15, 2023

Primary Completion (Estimated)

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.
November 1, 2028

Study Completion (Estimated)

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.
November 1, 2028

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).
November 17, 2023

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.
November 17, 2023

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.
November 24, 2023

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.
December 12, 2025

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.
December 11, 2025

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.
December 1, 2025

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.
  • IRB00404061

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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