Evaluating Stress Management Strategies Within the School Readiness Parenting Program

NCT ID: NCT06626750

Last Updated: 2025-10-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-07
• Study Completion Date: 2026-05-29

Brief Summary

The goal of this randomized study is to learn if adding three additional parent training sessions (focused on alleviating parental stress) to an already well-established treatment (School Readiness Parenting Program [SRPP]) in improving outcomes up to 6- and 12-months later for families of children with disruptive behavior disorders. The main questions it aims to answer are:

The primary objective of this protocol is to evaluate the effects of three additional cognitive behavioral therapy (CBT) based parent training sessions to the SRPP to reduce parent stress and improve parent-child interactions.

The secondary objective of this protocol is to evaluate the behavioral, emotional, and physical health-based functioning among young children with ADHD.

Researchers will compare families who receive the SRPP alone to families who receive the SRPP + the three additional CBT focused sessions.

Parents will be sent surveys to complete prior to the baseline assessment via REDCap (online). Parent and child participants will undergo 2 hours of baseline assessments evaluating behavioral, cognitive, and academic functioning as well as parent-child interactions. Parents will provide contact information for their child's teacher and the teacher will sent three surveys to complete online via REDCap.

Detailed Description

A total of 120 families will all receive a 7-week behavioral treatment (Summer Treatment Program) for children going into kindergarten or first grade with a disruptive behavior disorder. They will also be randomized to receive either a well-established school readiness parenting program (8 sessions) alone or the same parent training program with three additional parent training sessions (11 sessions). The three additional parent training sessions will include information on parental stress tolerance and cognitive-behavioral skills to improve parent's self-efficacy and sense of competence that are not included in the original school readiness parenting program. Parents will complete questionnaires and lab tasks with their child at baseline, 6-month follow up, and 12-month follow up. Lab tasks include a 15-minute parent-child play-like situation, and a 10-minute "difficult puzzle" task. The results of this research study may improve our understanding of child behavior and early school success and have important implications on parenting programs.

Conditions

Parenting; Stress; Disruptive Behavior Disorder; Parent-Child Relations; ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Traditional School Readiness Parenting Program

Parents will be required to attend a School Readiness Parenting Program for 1.5 to 2 hours weekly. Sessions include behavioral management strategies and school readiness. Behavior management strategies are delivered to the entire group via a Community Parent Education Program (COPE) style modeling problem solving approach; parents contribute to the didactic discussion. The behavioral management content is derived from Parent-Child Interaction Therapy (PCIT).

Group Type: ACTIVE_COMPARATOR

Summer Treatment Program for Pre-Kindergarteners and Kindergarteners

Intervention Type: BEHAVIORAL

Children will be concurrently enrolled in our Summer Treatment Program for Pre-Kindergarteners and Kindergarteners (STP-PreK/K). The STP-PreK/K simulates a school-like schedule and runs for 7-weeks and last 7 hours/day, Monday through Friday, with periods of seatwork, large/small group activities, circle time, and classroom meetings along with a recreational period. Academic curriculum are individualized depending upon child's current level. The behavioral modification program uses a visual response cost system in which children lose points for not following classroom rules (these rules are operationalized and determined during the development phase). Dots earned are then used for daily and weekly rewards. In addition to the academic and behavioral modification program, one group of children will participate in social-emotional/self-regulation training exercises on a daily basis designed to teach them social skills and how to control their emotions, behaviors, and attention.

School Readiness Parenting Program (SRPP)

Intervention Type: BEHAVIORAL

The School Readiness Parenting Program (SRPP) helps parents of young children develop skills that support their child\'s readiness for kindergarten and first grade. It focuses on positive parenting practices that enhance social, emotional, and cognitive development. The sessions cover managing child behaviors, promoting early literacy, and fostering problem-solving skills. Parents learn effective communication, consistent routines, and how to create a supportive home environment.

School Readiness Parenting Program + Cognitive Behavioral Therapy

For those randomly assigned to the additional parenting stress modules, parents will receive the same SRPP as well as three additional modules to target parenting stress. The modules will incorporate practices based on Cognitive-Behavioral Therapy (CBT).

Group Type: EXPERIMENTAL

Summer Treatment Program for Pre-Kindergarteners and Kindergarteners

Intervention Type: BEHAVIORAL

Children will be concurrently enrolled in our Summer Treatment Program for Pre-Kindergarteners and Kindergarteners (STP-PreK/K). The STP-PreK/K simulates a school-like schedule and runs for 7-weeks and last 7 hours/day, Monday through Friday, with periods of seatwork, large/small group activities, circle time, and classroom meetings along with a recreational period. Academic curriculum are individualized depending upon child's current level. The behavioral modification program uses a visual response cost system in which children lose points for not following classroom rules (these rules are operationalized and determined during the development phase). Dots earned are then used for daily and weekly rewards. In addition to the academic and behavioral modification program, one group of children will participate in social-emotional/self-regulation training exercises on a daily basis designed to teach them social skills and how to control their emotions, behaviors, and attention.

School Readiness Parenting Program (SRPP)

Intervention Type: BEHAVIORAL

The School Readiness Parenting Program (SRPP) helps parents of young children develop skills that support their child\'s readiness for kindergarten and first grade. It focuses on positive parenting practices that enhance social, emotional, and cognitive development. The sessions cover managing child behaviors, promoting early literacy, and fostering problem-solving skills. Parents learn effective communication, consistent routines, and how to create a supportive home environment.

Cognitive Behavioral Therapy (CBT)

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy (CBT) is a structured, goal-oriented therapy that helps individuals identify and change negative thought patterns and behaviors. It focuses on the link between thoughts, emotions, and actions to improve mental health. Specific to the current project, CBT can reduce stress by teaching parents to reframe unhelpful thoughts, manage challenging emotions, and develop effective coping strategies for difficult situations, leading to more positive parenting experiences.

Interventions

Summer Treatment Program for Pre-Kindergarteners and Kindergarteners

Children will be concurrently enrolled in our Summer Treatment Program for Pre-Kindergarteners and Kindergarteners (STP-PreK/K). The STP-PreK/K simulates a school-like schedule and runs for 7-weeks and last 7 hours/day, Monday through Friday, with periods of seatwork, large/small group activities, circle time, and classroom meetings along with a recreational period. Academic curriculum are individualized depending upon child's current level. The behavioral modification program uses a visual response cost system in which children lose points for not following classroom rules (these rules are operationalized and determined during the development phase). Dots earned are then used for daily and weekly rewards. In addition to the academic and behavioral modification program, one group of children will participate in social-emotional/self-regulation training exercises on a daily basis designed to teach them social skills and how to control their emotions, behaviors, and attention.

Intervention Type: BEHAVIORAL

School Readiness Parenting Program (SRPP)

The School Readiness Parenting Program (SRPP) helps parents of young children develop skills that support their child\'s readiness for kindergarten and first grade. It focuses on positive parenting practices that enhance social, emotional, and cognitive development. The sessions cover managing child behaviors, promoting early literacy, and fostering problem-solving skills. Parents learn effective communication, consistent routines, and how to create a supportive home environment.

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy (CBT)

Cognitive Behavioral Therapy (CBT) is a structured, goal-oriented therapy that helps individuals identify and change negative thought patterns and behaviors. It focuses on the link between thoughts, emotions, and actions to improve mental health. Specific to the current project, CBT can reduce stress by teaching parents to reframe unhelpful thoughts, manage challenging emotions, and develop effective coping strategies for difficult situations, leading to more positive parenting experiences.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• At-risk clinical range on the BASC-Preschool Version (per parent and teacher report) or clinical diagnosis of Attention-Deficit/Hyperactivity Disorder and/or Oppositional Defiant Disorder based on the Disruptive Behavior Disorders Scale or the Diagnostic Interview Schedule for Children
• Parent and teacher report of significant levels of impairment at home and at school on the Impairment Rating Scale

Exclusion Criteria

• Significant sensory impairments (e.g. deafness, blindness)
• Significant motor difficulties that impair mobility (e.g., cerebral palsy)
• Families with current Department of Children and Family (DCYF) involvement

Any family meeting exclusionary criteria will be referred to appropriate intervention services in Miami-Dade County. Children will not be excluded on the basis of race/ethnicity, sex, or socioeconomic status.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Florida International University

OTHER

Sponsor Role: lead

Responsible Party

Paulo A. Graziano, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Florida International University

Miami, Florida, United States

Countries

United States

Other Identifiers

IRB-23-0039

Identifier Type: -

Identifier Source: org_study_id