[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06197997":3,"trial-entities:NCT06197997":200,"trial-summary:NCT06197997":204},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":66,"sex":123,"minimum_age":124,"maximum_age":125,"healthy_volunteers":15,"eligibility_criteria":126,"std_ages":153,"locations":156,"central_contacts":187,"overall_officials":191,"references":194,"see_also_links":199},"NCT06197997","IRB00428221","Resilient, Engaged, and Connected Study","Strengthening Parenting, Young Children's Social-Behavioral Competence, and Kindergarten Readiness in Schools Serving Low-Income Communities","RECRUITING","2028-06-30","2026-03","2026-03-09","2024-09-01","Johns Hopkins University","OTHER",true,"Purpose of this study is to test the effectiveness and implementation of an evidence-based parenting intervention for improving parenting and school outcomes in a sample of 4-5-year-old children enrolled in public prekindergarten (PreK) programs in Maryland.","Using a hybrid Type 2 effectiveness-implementation design, this study tests the effectiveness and implementation of an evidence-based parenting intervention for improving parenting and school outcomes in a sample of 4-year-old children enrolled in public prekindergarten (PreK) programs in Maryland. Thirty Title 1 schools across two Maryland school districts (Baltimore City Public Schools n=20; Cecil County Public Schools n=10) will be randomized into experimental (receive the Chicago Parent Program intervention) or control (usual school practice) conditions. The Chicago Parent Program (CPP) is a 12-session group-based parenting intervention designed to strengthen parenting skills and parent engagement in children's learning and improve children's social-emotional and behavioral competence. All schools will participate for 2 years. In the experimental condition, school staff trained in CPP will implement the program in groups of 10-15 parents of PreK students in a virtual group or in-person group format (format order counterbalanced). Parents in the control condition will complete surveys only. Study outcomes for all participants will be evaluated at PreK baseline (T1), 4-5 months post baseline (T2), at the end of PreK (T3), in the fall of kindergarten (T4), and at the end of kindergarten (T5). Outcomes include children's social-emotional-behavioral competence, parent engagement in early childhood education, and parenting skills; school community cohesion; kindergarten readiness, chronic absence, and retained in kindergarten. Additional evaluation data will be collected in the experimental condition assessing perceived effectiveness, implementation quality, uptake, and cost-effectiveness to understand factors that affect the likelihood the program can be successfully integrated and sustained in urban and rural school settings. Demographic background variables will be collected from parents at baseline. Variables include the caregiver role in relation to the PreK child; the race, ethnicity, age, and gender of the parent and PreK child; primary language spoken in the home; and parents' education, employment status, marital status, and annual household income. The investigators will also assess nine family economic hardships experienced over the past 12 months. Demographic background variables will also be collected from PreK teachers at baseline and K teachers in the fall of K and will include gender, age, race, ethnicity, education, and teaching experience at the teacher's current school.",[19,20],"Parenting","Parenting Intervention",[19,22,23],"Chicago Parent Program","CPP","INTERVENTIONAL","PREVENTION",[27],"NA",{"count":29,"type":30},840,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","Chicago Parent Program (CPP)","The Chicago Parent Program (CPP) is a 12-session group-based parenting intervention designed to strengthen parenting skills and parent engagement in children's learning and improve children's social-emotional and behavioral competence.",[37],"Title 1 schools receive the Chicago Parent Program intervention",[39,43,47,50,54,57,60,63],{"measure":40,"description":41,"timeFrame":42},"Social-behavioral readiness as assessed by the social-behavioral domain of the Kindergarten Readiness Assessment (KRA).","School district's measure of children's social-behavioral readiness to learn at kindergarten entry. Kindergarten Readiness Assessment (KRA) assesses 4 domains of readiness. Domain scores range from 202-298. Higher score is a better outcome.","1-year follow-up",{"measure":44,"description":45,"timeFrame":46},"Percentage of children who reported chronic absence","Percent of children missing 10% or more school days during the kindergarten year. Data will be collected on number of days the school district records the students as absent from school.","1 year",{"measure":48,"description":49,"timeFrame":46},"Percentage of children who retained in grade","Percentage of children retained in kindergarten for another year. Data will be collected based on report from the school district on whether child was retained.",{"measure":51,"description":52,"timeFrame":53},"Social Competence and Behavior Evaluation (SCBE-30) score (Teacher Version)","change in measures of children's behavior and social-emotional skills from perspective of teachers. Teachers complete the Social Competence and Behavior Evaluation (SCBE-30). Teacher version contains 3 sub scales of 10 items each. Subscale scores range from 10- 60. Higher scores indicate higher levels of social competence.","Baseline, post-intervention up to 4 months, post-intervention up to 8 months, 1-year follow-up",{"measure":55,"description":56,"timeFrame":53},"Social Competence and Behavior Evaluation (SCBE-30) score (Parent Version)","change in measures of children's behavior and social-emotional skills from perspective of parents. Parent version of the SCBE-30 contains 3 sub scales of 10 items each. Subscale scores range from 10- 60. Higher scores indicate higher levels of social competence.",{"measure":58,"description":59,"timeFrame":53},"Eyberg Child Behavior Inventory (ECBI) score","change in child behavior problems on the Eyberg Child Behavior Inventory (ECBI) ECBI contains two sub scales of 36 items each; Intensity Scale scores can range from 36-252; Problem Scale scores can range from 0-36. Higher scores indicate worse outcomes.",{"measure":61,"description":62,"timeFrame":53},"Parent engagement as assessed by the Parent-Teacher Involvement Questionnaire","change in measures of parent's engagement in their children's early education from the perspective of teachers. Teachers will compete a 7-item measure of parent engagement from the Parent-Teacher Involvement Questionnaire. Scores range from 7-35. Higher scores indicate more parental involvement.",{"measure":64,"description":65,"timeFrame":53},"Parent engagement as assessed by the Parent Engagement in Early Childhood Education (PEECE) Survey","change in measure of parent engagement on the Parent Engagement in Early Childhood Education (PEECE) Survey, a 25-item measure of parent engagement. Scores can range from 25-100. Higher scores indicate higher involvement.",[67,70,74,78,82,86,90,94,97,101,104,107,110,113,117,120],{"measure":68,"description":69,"timeFrame":46},"Total kindergarten readiness score","Total kindergarten readiness score as assessed by the Kindergarten Readiness Assessment including language\u002Fliteracy, numeracy skills, physical well-being\u002Fmotor development, and social-behavioral readiness. Administered by and calculated by the school district.",{"measure":71,"description":72,"timeFrame":73},"Parenting skills as assessed by the Parenting Questionnaire","change in parenting skills measured by the Parenting Questionnaire a 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, post-intervention up to 3 months, 1-year follow-up",{"measure":75,"description":76,"timeFrame":77},"Social connectedness as assessed by Intervention Group Environment Scale","Measures parents' sense of belonging and connection with the school, using the 25-item Intervention Group Environment Scale and items are measured along a 5-point continuum of strongly disagree to strongly agree. Includes 3 sub scales. Scores can range from 0-5 with higher scores indicating greater social connectedness.","post-intervention up to 4 months",{"measure":79,"description":80,"timeFrame":81},"Parent Satisfaction as assessed by the Chicago Parent Program Satisfaction form","Measured using the Chicago Parent Program Parent Satisfaction Form. The survey Includes 16 items. Scored on a Likert-type scale, aspects of the program that were most and least beneficial, and the extent to which the participant would recommend the program to other parents. Each item is scored and interpreted separately.","Post-intervention up to 4 months",{"measure":83,"description":84,"timeFrame":85},"CPP Reach as assessed by percent of eligible parents enrolled","CPP Reach is defined by parent participation in CPP and will be measured by percent of eligible parents enrolled.","At baseline",{"measure":87,"description":88,"timeFrame":89},"CPP Effectiveness as assessed by End of Program Satisfaction score","Parents will complete the End of Program Satisfaction Form at post-intervention to assess their satisfaction of the extent to which CPP improved their parenting skills, their children's behavior, their confidence in supporting their children's school success; supported their relationships with their children's teacher and school; created challenges for participation (including technology challenges for virtual groups and transportation challenges for in person groups); and their overall satisfaction with CPP. 8 questions on a 4-point scale, 8 questions on a 3 point scale, and 4 open questions. Each item analyzed separately, higher scores indicate higher satisfaction.","Immediately post intervention",{"measure":91,"description":92,"timeFrame":93},"CPP Perceived effectiveness as assessed by qualitative interview","Perceived effectiveness will also be assessed from interviews with principals, school staff, and CPP group leaders (approximately 4 total individuals from each school) to understand their perceptions of CPP's benefits and limitations.","Immediately post-intervention (intervention group)",{"measure":95,"description":96,"timeFrame":93},"CPP Adoption as assessed by qualitative interview","CPP Adoption will be assessed from interviews with school staff involved in CPP implementation (i.e., CPP group leaders, school leadership - approximately 4 total individuals from each school) to understand whether and how CPP was folded into their normal workflow; perceived benefits and challenges with offering virtual versus in-person CPP; what the participant learned over the course of the two years of implementation; whether the participant would want to adopt CPP at their school and why; and if CPP were to continue at their school, what the participant believes is needed to make CPP work well for the participant.",{"measure":98,"description":99,"timeFrame":100},"Percentage of CPP group-leader retention rate","The investigators will collect data on group leader retention over two years","2 years",{"measure":102,"description":103,"timeFrame":100},"CPP Implementation challenges as assessed by qualitative interview","Differences in implementation challenges by rural versus urban school districts (e.g. travel distance to school, space in schools) and virtual versus in person groups (e.g. ease of internet access, space in schools).",{"measure":105,"description":106,"timeFrame":93},"Social Connectedness in Group Environments Scale (Parent)","Parent data will include CPP parent ratings of social connectedness formed within their group as measured by the Social Connectedness in Group Environments Scale. This is a 25-item parent report survey with 3 subscales measuring parents' perceptions of cohesion and sense of belonging among group members, extent to which group leaders generated a positive group environment and negative interactions among group members. Items are scored on a 5-point scale of strongly agree to strongly disagree. Score range 25-125. Higher score greater social connectedness.",{"measure":108,"description":109,"timeFrame":93},"Percentage of parents who completed CPP","CPP dose (number of sessions attended and CPP practice assignments completed) will be collected based on the session reports.",{"measure":111,"description":112,"timeFrame":93},"Quality of Parents' Participation in the CPP groups as assessed by the Quality of Participation score","This will be assessed after the 11th session by group leaders using the Quality of Participation Form (QPF). The QPF is a 7-item group-leader report of the extent to which parents are actively engaged in the group sessions supportive to other members in the group, open to trying to new strategies, and able to correctly apply program principles, and quality of parent participation in the CPP groups. Items are rated from 1 (not at all) to 4 (most of the time) and summed. Score range 7-28, higher score better quality.",{"measure":114,"description":115,"timeFrame":116},"CPP Implementation Quality as assessed by CPP Fidelity Checklist score","This will be assessed by independent raters from a random selection of three audio-recorded CPP sessions per 12-session group using the CPP Fidelity Checklist developed by the study team members. The CPP Fidelity Checklist assesses group leader competence (skill) and adherence to the protocol. For competence, there are 16 items (score range 1-3). For adherence, there are 12-14 items scored yes\u002Fno, and the score ranges from 0 to 100 percent adherence. Higher scores indicates better fidelity adherence.","Up to 12 weeks",{"measure":118,"description":119,"timeFrame":93},"Maintenance of CPP as assessed by implementation costs","Maintenance is defined as the likelihood of schools being able to sustain CPP. Data will include CPP implementation costs of in-person versus virtual CPP groups (including the Conditional Cash Transfers for participating in the CPP groups).",{"measure":121,"description":122,"timeFrame":93},"Maintenance of CPP as assessed by qualitative interview","Maintenance is defined as the perceived likelihood of schools being able to sustain CPP based on the interviews with school-based staff (approximately 4 total individuals from each school).","ALL","18 Years",null,{"inclusion":127,"exclusion":145,"raw_text":152},[128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144],"has at least 1 full-day public PreK classroom with 20+ students;","school has not offered CPP in the prior 3 years;","principal consents to being randomized and participate for 2 years;","principal consents to study team recruiting parents, teachers, and staff to participate in the study.","Parent (biological, step, adoptive, foster), grandparent, or legal guardian of 4-5 year old student enrolled in participating PreK program;","18+ yrs;","speaks English or Spanish;","consents to allowing access child's school identification.","PreK or K teacher in classroom of student of participating parent;","consents to completing study surveys.","completes CPP group leader training","agrees to lead CPP groups","speaks English or Spanish","at least a High School diploma\u002FGeneral Equivalency Diploma (GED)","consents to completing surveys and submitting audio recorded CPP sessions for fidelity assessment","Principal, teacher, or other school-based staff involved in CPP implementation","consents to interview on perspectives about CPP in the school",[146,147,148,149,150,151],"Principal cannot commit staff to offering CPP groups","school previously offered CPP in prior 3 years","school located in a geographic area with less than 80% connectivity","PreK Parents previously participated in CPP","Teachers: teacher also a participating parent or CPP group leader","School-based personnel: Principal, teacher, or other school-based staff is a study parent","Inclusion Criteria:\n\nPublic school or Community School in Baltimore City, Cecil County, or Harford County serving at least 40% of students meeting eligibility for low-income or located in a community designated as high need by the Maryland State Department of Education based on a score of 0.6 on the Center for Disease Control Social Vulnerability Index:\n\n* has at least 1 full-day public PreK classroom with 20+ students;\n* school has not offered CPP in the prior 3 years;\n* principal consents to being randomized and participate for 2 years;\n* principal consents to study team recruiting parents, teachers, and staff to participate in the study.\n\nPreK Parents:\n\n* Parent (biological, step, adoptive, foster), grandparent, or legal guardian of 4-5 year old student enrolled in participating PreK program;\n* 18+ yrs;\n* speaks English or Spanish;\n* consents to allowing access child's school identification.\n\nTeachers:\n\n* PreK or K teacher in classroom of student of participating parent;\n* consents to completing study surveys.\n\nCPP Group Leaders:\n\n* completes CPP group leader training\n* agrees to lead CPP groups\n* speaks English or Spanish\n* at least a High School diploma\u002FGeneral Equivalency Diploma (GED)\n* consents to completing surveys and submitting audio recorded CPP sessions for fidelity assessment\n\nSchool-based personnel inclusion criteria:\n\n* Principal, teacher, or other school-based staff involved in CPP implementation\n* consents to interview on perspectives about CPP in the school\n\nExclusion Criteria:\n\n* Principal cannot commit staff to offering CPP groups\n* school previously offered CPP in prior 3 years\n* school located in a geographic area with less than 80% connectivity\n* PreK Parents previously participated in CPP\n* Teachers: teacher also a participating parent or CPP group leader\n* School-based personnel: Principal, teacher, or other school-based staff is a study parent",[154,155],"ADULT","OLDER_ADULT",[157,179],{"facility":158,"status":8,"city":159,"state":160,"zip":161,"country":162,"contacts":163,"geoPoint":176},"Johns Hopkins School of Nursing","Baltimore","Maryland","21205","United States",[164,169,173,175],{"name":165,"role":166,"phone":167,"email":168},"Deborah Gross, DNSc","CONTACT","410-614-5311","debgross@jhu.edu",{"name":170,"role":166,"phone":171,"email":172},"Amie Bettencourt, PhD","410-955-8021","abetten3@jhu.edu",{"name":165,"role":174},"PRINCIPAL_INVESTIGATOR",{"name":170,"role":174},{"lat":177,"lon":178},39.29038,-76.61219,{"facility":13,"status":180,"city":159,"state":160,"zip":161,"country":162,"contacts":181,"geoPoint":186},"NOT_YET_RECRUITING",[182,183,184,185],{"name":165,"role":166,"phone":167,"email":168},{"name":170,"role":166,"phone":171,"email":172},{"name":165,"role":174},{"name":170,"role":174},{"lat":177,"lon":178},[188,189],{"name":165,"role":166,"phone":167,"email":168},{"name":190,"role":166,"phone":171,"email":172},"Amie F Bettencourt, PhD",[192],{"name":165,"affiliation":193,"role":174},"JHU School Of Nursing",[195],{"pmid":196,"type":197,"citation":198},"40246571","DERIVED","Gross D, Breitenstein SM, Jeon L, Perrin N, Shen K, Bettencourt AF. Resilient, engaged and connected (REC) study: protocol for a type 2 cluster-randomised trial of the Chicago Parent Program in prekindergarten in low-income urban and rural communities. BMJ Open. 2025 Apr 17;15(4):e099204. doi: 10.1136\u002Fbmjopen-2025-099204.",[],{"nct_id":4,"conditions":201,"biomarkers":203},[202],"Rapid shallow breathing",[],{"nct_id":4,"found":15,"summary":205,"prompt_version":215},{"design":206,"status":207,"heading":208,"summary":209,"follow_up":210,"word_count":211,"commitments":212,"compensation":213,"drugs_mentioned":214},"This study will involve 840 participants from 30 schools. Schools will be randomly assigned to either receive the Chicago Parent Program intervention or continue with usual school practices.","completed","Resilient, Engaged, and Connected Study for Parenting and School Outcomes","This study, called the \"Resilient, Engaged, and Connected Study,\" is testing a program called the Chicago Parent Program (CPP). This program is a 12-session group-based intervention designed to help parents strengthen their parenting skills and get more involved in their children's learning. The goal is to improve children's social-emotional and behavioral skills. We are looking for parents of 4-5-year-old children in public prekindergarten (PreK) programs in Baltimore City, Cecil County, or Harford County in Maryland. The study will measure how well children are ready for kindergarten socially and behaviorally, as well as their school attendance and whether they repeat a grade, all measured one year after the program. The current recruitment status is unclear.","Participants will be followed for one year after the intervention to assess social-behavioral readiness, chronic absence, and grade retention.",114,"If your school is in the experimental group, you would participate in 12 group sessions of the Chicago Parent Program, either virtually or in-person. If your school is in the control group, you would complete surveys only. All participants will have outcomes evaluated at multiple points over two years.","Not stated in the trial record.",[34],"v2"]