ParentingNCT06145477
Parenting for Tomorrow: A New Model for Supporting Preschool Children's Mental Health in Head Start
An observational study of Parenting and Parenting Intervention, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Parenting, Parenting Intervention
- What is being tested?
- Chicago Parent Program - individualized for families (CPPi)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2023to Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Parent does not speak English or Spanish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21205
About this study
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.
Read the 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.
- Conditions
- Parenting, Parenting Intervention
- Being tested
- Chicago Parent Program - individualized for families (CPPi)
- Keywords
- Parenting, Chicago Parent Program, CPPi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chicago Parent Program - individualized for families (CPPi)Behavioural
CPPi is a 8-12 session individual- based parenting skills program
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Chicago Parent Program - individualized for families (CPPi) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Child Social - Emotional and Behavioral Wellbeing as assessed by the Strength & Difficulties Questionnaire (SDQ)
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.
Measured: Baseline, immediately after the intervention
Change in Child Anxiety as assessed by the Preschool Anxiety Scale (PAS)
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.
Measured: 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)
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.
Measured: Baseline, immediately after the intervention
Change in parenting skills as assessed by the Parenting Questionnaire (PQ)
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.
Measured: Baseline, immediately after the intervention
Change in parenting confidence as assessed by the Parenting Sense of Competence Scale (PSOC)
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.
Measured: 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
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.
Measured: 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
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.
Measured: Immediately after the intervention
Number of referred families who initiate CPPi treatment as assessed by a survey developed by the study team
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.
Measured: Immediately after the intervention
Average attendance by parents to scheduled CPPi sessions as assessed by a survey developed by the study team
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.
Measured: Immediately after the intervention
Number of CPPi modules completed as assessed by a survey developed by the study team
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.
Measured: Immediately after the intervention
Number of parents completing CPPi as assessed by a survey developed by the study team
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.
Measured: Immediately after the intervention
Number of missed appointments without cancellation for CPPi sessions as assessed by a survey developed by the study team
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.
Measured: Immediately after the intervention
Number of internet connectivity issues experienced during CPPi sessions as assessed by a survey developed by the study team
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.
Measured: Immediately after the intervention
Percentage of improvement in participants' perceived effectiveness of CPPi as assessed by a survey developed by the study team
The CPPi acceptability will be assessed by measuring the impact of CPPi on participants' perceived efficacy.
Measured: 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.
The CPPi acceptability will also be assessed by measuring the referral, scheduling process, and virtual format for CPPi sessions.
Measured: Immediately after the intervention
Percentage of participants rating CPPi as user-friendly as assessed by a survey developed by the study team.
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.
Measured: 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.
The CPPi acceptability will also be assessed by measuring the quality of therapeutic relationship between parents and the CPPi nurses.
Measured: Immediately after the intervention
Parent's satisfaction as assessed by a survey developed by the study team
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.
Measured: Immediately after the intervention
CPPi sustainability as assessed by a survey developed by the study team
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.
Measured: Immediately after the intervention
Implementation cost as assessed by a survey developed by the study team
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.
Measured: Immediately after the intervention
Percent of CPPi nurses who adhere to the CPPi program as assessed by a survey developed by the study team
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).
Measured: Immediately after the intervention
Number of CPPi sessions attended by the parents as assessed by a survey developed by the study team
The CPPi Program participation ranges from 0-12 sessions.
Measured: Immediately after the intervention
Secondary outcomes (2)
Change in parental mental health - anxiety as assessed by the Generalized Anxiety Disorder Scale (GAD-7)
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.
Measured: Baseline, immediately after the intervention
Change in parental mental health - depressive symptoms as assessed by the Patient Health Questionnaire-Depression Scale (PHQ-8)
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.
Measured: Baseline, immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start15 Nov 2023
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentingStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Rita & Alex Hillman Foundation, Richman Foundation, Sherman Family Foundation, Blanket Fort Foundation, Wright Family Foundation, Abell Foundation, Baltimore Community Foundation
- Responsible party
- Sponsor
- Investigators
- Deborah Gross, DNSc, Principal investigator, JHU School Of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145477
- Sponsor's protocol ID
- IRB00404061
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2023
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parenting for Tomorrow: A New Model for Supporting Preschool Children's Mental Health in Head Start
- ClinicalTrials.gov ID
- NCT06145477
- Acronym / sponsor ID
- IRB00404061
- Conditions
- Parenting, Parenting Intervention
- Keywords
- Parenting, Chicago Parent Program, CPPi
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Rita & Alex Hillman Foundation, Richman Foundation, Sherman Family Foundation, Blanket Fort Foundation, Wright Family Foundation, Abell Foundation, Baltimore Community Foundation
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parents enroll in Parenting for Tomorrow using Chicago Parent Program - individualized for families | – | Behavioral: Chicago Parent Program - individualized for families (CPPi)Parents enroll in Parenting for Tomorrow using Chicago Parent Program - individualized for families (CPPi) implemented through a telehealth approach. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Parent does not speak English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chicago Parent Program - individualized for families (CPPi)CPPi is a 8-12 session individual- based parenting skills program | Behavioural | Parents enroll in Parenting for Tomorrow using Chicago Parent Program - individualized for families |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
Related trials for Parenting
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Recruiting
Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples
Anxiety, Pregnancy
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Not yet recruitingObservational study
The Effects of Extreme Prematurity on Parenting
Depression Disorder, Post Traumatic Stress Disorder PTSD
Enrolling by invitationObservational study
Long-term Impacts of Psychosocial Stimulation and Iron Supplementation
Iron Deficiency Anemia, Parenting Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deborah Gross, DNSc principal investigator
JHU School Of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parenting and Parenting Intervention, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deborah Gross, DNSc (410-614-5311, debgross@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.