Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:32 AM
Study NCT ID:
NCT07445867
Status:
COMPLETED
Last Update Posted:
2026-03-03
First Post:
2026-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness Evaluation of a Comprehensive School Readiness Summer Program for Young Children At-Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-20', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Program attendance', 'timeFrame': 'Throughout the 7-week intervention', 'description': 'Child attendance was measured for each camp day via data collection sheets utilized in each activity. Parent attendance in parent training was similarly measured via attendance sheets.'}, {'measure': 'Program satisfaction and treatment acceptability.', 'timeFrame': 'At the end of the 7 week intervention', 'description': "Caregivers completed a satisfaction questionnaire as part of their post-intervention battery. The satisfaction questionnaire consisted of 22 items. On 20-items caregivers rate, on a 4-7 point Likert-type scale, the extent to which they agree or disagree (e.g., this program helps my child do better in school, I would recommend this program to others, I feel welcomed by staff), sense of improvement (e.g., child behavior, their relationship with their child), their confidence in using strategies (e.g., parenting, managing future behavior problems), and perceptions of the program (e.g., child's progress). The measure also includes two open-response items (i.e., what do you like best about the program; what do you wish you could change about the program)."}, {'measure': 'Program Fidelity', 'timeFrame': 'Weekly throughout the 7-week intervention', 'description': "A full program day was observed weekly for each classroom, by the program's clinical and assistant clinical directors. For each observation, coders completed a fidelity checklist to measure the extent to which classroom staff were adhering to the behavior modification system (e.g., point system, individualized and class-wide behavioral targets, time-outs) and the social-emotional and academic curriculums. Fidelity checklists also included measurement of social reinforcement (e.g., praise to rule violation ratio above 3:1). Fidelity was also collected during parent training meetings following similar checklist procedures."}], 'primaryOutcomes': [{'measure': 'Behavioral Functioning', 'timeFrame': 'From enrollment until the end of intervention at 7 weeks and then again at six months follow up', 'description': "Caregivers completed the Behavior Assessment System for Children, 3rd Edition (BASC-3; Reynolds \\& Kamphaus, 2018). The BASC-3 is a widely used behavior checklist that taps emotional and behavioral domains of children's functioning. The parent version used for preschool children contains 139 items."}, {'measure': 'Behavioral Symptomatology', 'timeFrame': 'From enrollment until the end of intervention at 7 weeks and then again at six months follow up', 'description': 'Symptoms of ADHD, ODD, and Early Conduct Symptoms were measured at each time point using the parent Disruptive Behavior Disorder (DBD) Rating Scale (Pelham et al., 1992). The DBD consists of 45-items that correspond with DSM diagnostic symptomatology for ADHD-Inattention (9 items), ADHD-hyperactivity/impulsivity (9 items), ODD (8 items) and Conduct Disorder (15 items). Caregivers rate each item on a four-point scale (not at all, just a little, pretty much, very much). Items rated as pretty much or very much are considered as positive, or endorsed, symptoms.'}, {'measure': 'Behavioral Impairment', 'timeFrame': 'From enrollment until the end of intervention at 7 weeks and then again at six months follow up', 'description': "Caregivers completed the Impairment Rating Scale (IRS; Fabiano, et al., 2006) at all three assessment time points. The IRS measures the severity of impairment caused by children's difficulty across several domains of functioning (e.g., academic functioning, family functioning, relationships parents, overall) on a 7-point scale, ranging from 0 (no impairment) to 6 (extreme impairment)."}, {'measure': 'Pre-academic skills', 'timeFrame': 'From enrollment until the end of intervention at 7 weeks and then again at six months follow up', 'description': 'Through direct child testing, pre-academic skills were measured at each time point using the Bracken School Readiness Assessment (BSRA; Bracken, 2002). The BRSA is a measure for children pre-k to 2nd grade and assesses several school readiness domains (i.e., receptive knowledge of colors, shapes, numbers, letters, and spatial/size relations).'}, {'measure': 'Executive functioning', 'timeFrame': 'From enrollment until the end of intervention at 7 weeks and then again at six months follow up', 'description': 'At each time point, the Head-Toes-Knees-Shoulders task (HTKS; Ponitz et al., 2009) was administered. The HTKS is a tool to objectively measure executive functioning executive functioning skills in preschool children. The HTKS has been widely used with good psychometrics (Ponitz et al., 2009; Wanless et al., 2011) and validated in a sample of preschool children with externalizing behavior problems (Graziano et al., 2015). The HTKS task prompts children to perform paired behavioral responses in the opposite way (e.g., when I say "touch your head" touch your toes). Scores range from 0 to 60, with 2 points for initial accurate opposite responses, 1 point for self-corrected responses, and 0 points for inaccurate responses. Higher scores indicate more developed executive functioning skills.'}, {'measure': 'Parenting Practices', 'timeFrame': 'From enrollment until the end of intervention at 7 weeks and then again at six months follow up', 'description': 'The Alabama Parenting Questionnaire-Preschool Version (APQ-PR; Shelton, Frick, \\& Wootton, 1996) will be completed at each time point and consists of 42 items that are designed to measure parenting practices across five domains: parental involvement, positive parenting, poor monitoring/supervision, inconsistent discipline, and corporal punishment. Ratings of the items are made on a 5-point scale (never, almost never, sometimes, often, always). The APQ has good psychometric properties, including criterion validity in differentiating clinical and nonclinical groups (Frick, Christian, \\& Wootton, 1999; Shelton et al., 1996) and has been used with parents of children as young as three years of age (Clerkins, Marks, Policaro, \\& Halperin, 2007).'}, {'measure': 'Parenting Stress', 'timeFrame': 'From enrollment until the end of intervention at 7 weeks and then again at six months follow up', 'description': "The Parenting Stress Index-Short Form (PSI-SF; Abidin, 1983) will be completed at each time point and is a 36-item self-report instrument for parents of children ages 1 month to 12 years containing three subscales (Parent Distress, Parent-Child Dysfunctional Interaction, Difficult Child) with Cronbach's alphas of .87, .80, and .85, respectively, and 6-month test-retest reliabilities of 0.85, 0.68, and 0.78, respectively (Abidin, 1983). The PSI and the PSI-SF total scores are highly correlated with one another (.94). On the long form of the PSI, higher scores have been associated with increased severity of conduct-disordered behavior (Eyberg, Boggs, \\& Rodriguez, 1992; Ross, Blanc, McNeil, Eyberg, \\& Hembree-Kigin, 1998). The PSI-SF will be used to assess the effects of PCIT on parent stress."}, {'measure': 'Parent-Child Interaction', 'timeFrame': 'From enrollment until the end of intervention at 7 weeks and then again at six months follow up', 'description': 'The Dyadic Parent-Child Interaction Coding System-Third Edition (DPICS-III; Eyberg, Nelson, Duke, \\& Boggs, 2005) is a behavioral coding system that measures the quality of parent-child interactions during three 5-minutes standard situations that vary in the degree of parental control (i.e., child-led play, parent-led play, and clean-up), as well as during during a shared-reading task. The convergent and discriminative validity of the DPICS categories have been extensively documented and the psychometric data are summarized in the DPICS manual (Eyberg et al., 2004). A copy of the DPICS-III manual is not included with this proposal due to its extremely large size (260 pages). The manual is not given to participants; it is only used when coding the videotaped parent-child interactions. The manual is available on line at www.pcit.org for review. For the current study, parent and child behaviors will be measured to examine changes in the parent-child relationship and literacy engagement.'}], 'secondaryOutcomes': [{'measure': 'Parent perceptions of education', 'timeFrame': 'From enrollment until the end of intervention at 7 weeks and then again at six months follow up', 'description': "The Parent Perceptions of Education is a 38-item measure comprised of five previously developed scales (Hoover-Dempsey \\& Sandler, 2005; Walker, Wilkins, Dallaire, Sandler, \\& Hoover-Dempsey, 2005) will be completed by parents pre- and post-intervention to assess the following aspects of parental role in the facilitation of early learning: (a) parents' beliefs about their efficacy for helping their children succeed in school; (b) parents' beliefs about involvement in the child's education; (c) parents' beliefs about personal knowledge and skills for involvement in the child's education; (d) parents' perceptions about how much time and energy they perceive they have for engaging in school related activities; and (e) parent's attraction to or general disposition toward schools, based on his or her prior personal experience with schools."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['early intervention', 'Summer Treatment Program Adaptations', 'ADHD', 'externalizing behavior problems', 'underserved populations'], 'conditions': ['Externalizing Behavior']}, 'descriptionModule': {'briefSummary': "This study is a program evaluation or open-trial study of the effectiveness of Summer Academy, a comprehensive summer early intervention program for young children with early learning and disruptive behavior problems (based on the nationally recognized, evidence-based Children's Summer Treatment Program) living in at-risk community settings. The summer program, which is funded by The Children's Trust, will be held annually from June to August from Summer 2016 - Summer 2019 at an early childhood center located in the Liberty City community of Miami, FL. Our aims are to evaluate how well the program helps to prepare young children for the transition to kindergarten and measure to how well progress is maintained at six-month follow-up.", 'detailedDescription': "Research design\n\nThis study is a program evaluation or open-trial study of the effectiveness of FIU Summer Academy, a comprehensive summer early intervention program for young children with early learning and disruptive behavior problems (based on the nationally recognized, evidence-based Children's Summer Treatment Program) living in at-risk community settings. The summer program, which is funded by The Children's Trust, will be held annually from June to August from Summer 2016 - Summer 2019 at an early childhood center located in the Liberty City community of Miami, FL. Our aims are to evaluate how well the program helps to prepare young children for the transition to kindergarten and measure to how well progress is maintained at six-month follow-up.\n\nThere will be two phases to this study. The first phase (Phase I) will include a series of focus groups to be held annually with parents, teachers, and community stakeholders to obtain feedback on the program to determine what, if any changes, need to be made to current programming to maximize effectiveness. The second phase (Phase II), will consist of direct program evaluation.\n\nProcedures to be used\n\nIn Phase I, we will recruit parents, teachers, and community stakeholders to participate in a 1 hour focus group to obtain feedback on the program to determine what, if any changes, need to be made to current programming to maximize effectiveness.\n\nIn Phase II, children and their families will be recruited to participate in the summer program through direct school and community referrals. Several process measures (e.g., attendance, satisfaction ratings) will be used to determine the feasibility of the intervention. Other outcome measures, obtained via multiple reports (i.e., parent, teacher, \\& observations), examining children's behavioral functioning, self-regulation skills, parental involvement, and academic achievement will be used to both examine aspects of treatment integrity and the effects of the various components of the intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children were:\n\n 1. transitioning to kindergarten the following school year;\n 2. had behavioral, learning, attention, or other social emotional difficulties, as evidenced by meeting diagnostic criteria for a behavioral or emotional disorder (e.g., Attention-Deficit/Hyperactivity Disorder, Oppositional Defiant Disorder) or qualify for special education services via an Individualized Education Program (IEP);\n 3. had the cognitive and language skills needed to appropriately benefit from the program; and\n 4. be able to attend the 7-week intervention program with weekly parent training.\n\nExclusion Criteria:\n\n* Child did not meet any of the inclusion criteria above,\n* Child was not residing with their legal guardian.'}, 'identificationModule': {'nctId': 'NCT07445867', 'briefTitle': 'Effectiveness Evaluation of a Comprehensive School Readiness Summer Program for Young Children At-Risk', 'organization': {'class': 'OTHER', 'fullName': 'Florida International University'}, 'officialTitle': 'Effectiveness Evaluation of a Comprehensive School Readiness Summer Program for Young Children At-Risk', 'orgStudyIdInfo': {'id': 'IRB-16-0101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Summer Academy', 'description': 'All children received a seven-week comprehensive school readiness program adapted from the STP-PreK program (Graziano \\& Hart, 2016; Hart, Maharaj, \\& Graziano, 2019) that ran from June to early August over the course of three summers. Summer Academy followed the behavioral, social-emotional, academic, and recreational intervention procedures consistent with STP-PreK, including procedures and structure of staff training and supervision, but differed in programmatic aspects in several key ways that were made to meet the needs of the community. Caregivers were required to attend weekly caregiver groups following a modified School Readiness Parent Program (SRPP; Graziano et al., 2018).', 'interventionNames': ['Behavioral: Summer Academy']}], 'interventions': [{'name': 'Summer Academy', 'type': 'BEHAVIORAL', 'otherNames': ['STP-PreK'], 'description': 'All children received a seven-week comprehensive school readiness program adapted from the STP-PreK program (Graziano \\& Hart, 2016; Hart, Maharaj, \\& Graziano, 2019) that ran from June to early August over the course of three summers. Summer Academy followed the behavioral, social-emotional, academic, and recreational intervention procedures consistent with STP-PreK, including procedures and structure of staff training and supervision, but differed in programmatic aspects in several key ways that were made to be responsive to community needs. Caregivers were required to attend weekly caregiver groups following a modified School Readiness Parent Program (SRPP; Graziano et al., 2018).', 'armGroupLabels': ['Summer Academy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33199', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida International University, Center for Children and Families', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Katie Hart, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida International University', 'class': 'OTHER'}, 'collaborators': [{'name': "The Children's Trust, Miami FL", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}