Clinical trial NCT06145477: Parenting for Tomorrow: A New Model for Supporting Preschool Children's Mental Health in Head Start
Official title: Parenting for Tomorrow: A New Model for Supporting Preschool Children's Mental Health in Head Start
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parenting
Parenting Intervention
Keywords: Parenting
Chicago Parent Program
CPPi
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: The Rita and Alex Hillman Foundation
name: Richman Foundation
name: Sherman Family Foundation
name: Blanket Fort Foundation
name: Wright Family Foundation
name: Abell Foundation
name: Baltimore Community Foundation
First posted: 2023-11-24
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

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.

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.

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

Primary outcomes:
measure: Change in Child Social - Emotional and Behavioral Wellbeing as assessed by the Strength & Difficulties Questionnaire (SDQ)
timeFrame: Baseline, immediately after the intervention
measure: Change in Child Anxiety as assessed by the Preschool Anxiety Scale (PAS)
timeFrame: Baseline, immediately after the intervention
measure: Change in Child Social - Emotional and Behavioral Wellbeing in the Classroom as assessed by the Social Competence and Behavior Evaluation (SCBE)
timeFrame: Baseline, immediately after the intervention
measure: Change in parenting skills as assessed by the Parenting Questionnaire (PQ)
timeFrame: Baseline, immediately after the intervention
measure: Change in parenting confidence as assessed by the Parenting Sense of Competence Scale (PSOC)
timeFrame: Baseline, immediately after the intervention
measure: Number of referred children with clinically significant social-emotional and behavioral scores as assessed by a survey developed by the study team
timeFrame: Immediately after the intervention
measure: Length of time (in days) from referral to first CPPi appointment as assessed by a survey developed by the study team
timeFrame: Immediately after the intervention
measure: Number of referred families who initiate CPPi treatment as assessed by a survey developed by the study team
timeFrame: Immediately after the intervention
measure: Average attendance by parents to scheduled CPPi sessions as assessed by a survey developed by the study team
timeFrame: Immediately after the intervention
measure: Number of CPPi modules completed as assessed by a survey developed by the study team
timeFrame: Immediately after the intervention
measure: Number of parents completing CPPi as assessed by a survey developed by the study team
timeFrame: Immediately after the intervention
measure: Number of missed appointments without cancellation for CPPi sessions as assessed by a survey developed by the study team
timeFrame: Immediately after the intervention
measure: Number of internet connectivity issues experienced during CPPi sessions as assessed by a survey developed by the study team
timeFrame: Immediately after the intervention
measure: Percentage of improvement in participants' perceived effectiveness of CPPi as assessed by a survey developed by the study team
timeFrame: Immediately after the intervention
measure: Percentage of participants reporting satisfaction with the CPPi referral, scheduling process, and virtual format as assessed by a survey developed by the study team.
timeFrame: Immediately after the intervention
measure: Percentage of participants rating CPPi as user-friendly as assessed by a survey developed by the study team.
timeFrame: Immediately after the intervention
measure: Participants' ratings of the quality of therapeutic relationship with CPPi nurses as assessed by a survey developed by the study team.
timeFrame: Immediately after the intervention
measure: Parent's satisfaction as assessed by a survey developed by the study team
timeFrame: Immediately after the intervention
measure: CPPi sustainability as assessed by a survey developed by the study team
timeFrame: Immediately after the intervention
measure: Implementation cost as assessed by a survey developed by the study team
timeFrame: Immediately after the intervention
measure: Percent of CPPi nurses who adhere to the CPPi program as assessed by a survey developed by the study team
timeFrame: Immediately after the intervention
measure: Number of CPPi sessions attended by the parents as assessed by a survey developed by the study team
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Change in parental mental health - anxiety as assessed by the Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: Baseline, immediately after the intervention
measure: Change in parental mental health - depressive symptoms as assessed by the Patient Health Questionnaire-Depression Scale (PHQ-8)
timeFrame: Baseline, immediately after the intervention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: JHU School Of Nursing
name: Deborah Gross, DNSc
role: PRINCIPAL_INVESTIGATOR
References: