Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT06145477

Conditions

Parenting

Parenting Intervention

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Chicago Parent Program - individualized for families (CPPi)

Study Details

Brief summary:

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.

Conditions

Parenting

Parenting Intervention

Study ID

NCT06145477

Start date

Nov 15, 2023

Status verified date

Dec, 2025

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Chicago Parent Program - individualized for families (CPPi)

CPPi is a 8-12 session individual- based parenting skills program

Primary outcome measure

  • Change in Child Social - Emotional and Behavioral Wellbeing as assessed by the Strength & Difficulties Questionnaire (SDQ) [ Time Frame: Baseline, immediately after the intervention ]
  • Change in Child Anxiety as assessed by the Preschool Anxiety Scale (PAS) [ Time Frame: 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 ]
  • Change in parenting skills as assessed by the Parenting Questionnaire (PQ) [ Time Frame: 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 ]
  • 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 ]
  • 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 ]
  • Number of referred families who initiate CPPi treatment as assessed by a survey developed by the study team [ Time Frame: 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 ]
  • Number of CPPi modules completed as assessed by a survey developed by the study team [ Time Frame: 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Percentage of participants rating CPPi as user-friendly as assessed by a survey developed by the study team. [ Time Frame: 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 ]
  • Parent's satisfaction as assessed by a survey developed by the study team [ Time Frame: Immediately after the intervention ]
  • CPPi sustainability as assessed by a survey developed by the study team [ Time Frame: Immediately after the intervention ]
  • Implementation cost as assessed by a survey developed by the study team [ Time Frame: 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 ]
  • Number of CPPi sessions attended by the parents as assessed by a survey developed by the study team [ Time Frame: Immediately after the intervention ]

Central Contacts and Locations

Central contacts

Amie F Bettencourt, PhD

410-955-8021abetten3@jhu.edu

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21205

More Information

Sponsor

Johns Hopkins University

Last update posted

Dec 12, 2025

Last verified

Dec, 2025

Keywords

  • Parenting
  • Chicago Parent Program
  • CPPi

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2025-12-12.