Evaluating Stress Management Strategies Within the School Readiness Parenting Program

NCT06626750 | Active Not Recruiting

• 1 other identifier: IRB-23-0039
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Parent Stress Index (PSI)

  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). Total scores range between 36 to 180, with higher scores indicating higher levels of perceived parenting stress.

  Baseline, between 4 to 6 months after baseline (post treatment), and 12-months

• Dyadic Parent-Child Interaction Coding System

  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., parent reading to child, child-led play, parent-led play, and clean-up). Parent verbalizations are coded for positive and negative communication patterns and are totaled at the end of each 5-minute situation.

  Baseline, between 4 to 6 months after baseline (post treatment), and 12-months

• Difficult Puzzle Lab Task - Early Parenting Coding System (EPCS)

  Co-operative goal-directed interactions between mothers and children will be coded from a video of mother-child interactions in a laboratory task intended to be moderately stressful for the dyad. The EPCS captures a range of parenting behaviors that are typically exhibited in interactions with young children. This coding system consists of nine global ratings. Behaviors are rated on a Likert scale, with scores ranging from low to high (i.e.,1 to 7), with higher scores indicating more positive parenting behaviors.

  Baseline, between 4 to 6 months after baseline (post treatment), and 12-months

• Cognitive Behavioral Therapy Parent Quiz

  Parents will complete a 25-item multiple choice quiz on cognitive behavioral therapy skills. Scores range from 0% to 100%, with higher percentages indicating greater knowledge of session material.

  Baseline, between 4 to 6 months after baseline (post treatment), and 12-months

Secondary Outcomes (5)

• Behavior Assessment System for Children

  Baseline, post treatment, 12-months

• Disruptive Behavior Disorders Rating Scale

  Baseline, post treatment, 12-months

• Treatment Satisfaction Survey

  Post treatment

• SRPP activities practice

  During/Post-treatment

• Difficult Puzzle Lab Task - Early Parenting Coding System (EPCS)

  Baseline, post treatment, 12-months

Study Arms (2)

Traditional School Readiness Parenting Program

ACTIVE COMPARATOR

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).

Behavioral: Summer Treatment Program for Pre-Kindergarteners and Kindergarteners; Behavioral: School Readiness Parenting Program (SRPP)

School Readiness Parenting Program + Cognitive Behavioral Therapy

EXPERIMENTAL

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).

Behavioral: Summer Treatment Program for Pre-Kindergarteners and Kindergarteners; Behavioral: School Readiness Parenting Program (SRPP); Behavioral: Cognitive Behavioral Therapy (CBT)

Interventions

Summer Treatment Program for Pre-Kindergarteners and Kindergarteners 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 + Cognitive Behavioral Therapy; Traditional School Readiness Parenting Program

School Readiness Parenting Program (SRPP) 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; Traditional School Readiness Parenting Program

Cognitive Behavioral Therapy (CBT) 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.

School Readiness Parenting Program + Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida International University: lead

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

Location

MeSH Terms

Conditions

Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: October 4, 2024
• Study Start: February 7, 2023
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): May 29, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon completion of study and for 3 years.

Locations

US (1)