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Recruiting NCT06145477

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

Observational Parenting Parenting Intervention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chicago Parent Program - individualized for families (CPPi).
Who it may be relevant to
Registry conditions: Parenting, Parenting Intervention. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Interventions

  • Behavioral Chicago Parent Program - individualized for families (CPPi)
    CPPi is a 8-12 session individual- based parenting skills program

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • Change in parental mental health - anxiety as assessed by the Generalized Anxiety Disorder Scale (GAD-7) [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Ecologic or community

Study locations

United States · 1 center
  • Johns Hopkins University — Baltimore

Identifiers

NCT: NCT06145477 · IRB00404061

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗