ParentingNCT06626750
Evaluating Stress Management Strategies Within the School Readiness Parenting Program
A study testing Summer Treatment Program for Pre-Kindergarteners and Kindergarteners, School Readiness Parenting Program (SRPP) and Cognitive Behavioral Therapy (CBT) in people with Parenting and Stress, run by Florida International University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Parenting, Stress, Disruptive Behavior Disorder
- What is being tested?
- Summer Treatment Program for Pre-Kindergarteners and Kindergarteners, School Readiness Parenting Program (SRPP) and Cognitive Behavioral Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2023to 29 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University
Miami, Florida, 33199
About this study
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.
Read more
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.
Read the 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
- Being tested
- Summer Treatment Program for Pre-Kindergarteners and Kindergarteners, School Readiness Parenting Program (SRPP), Cognitive Behavioral Therapy (CBT)
- Medical subject headings
- Attention Deficit and Disruptive Behavior Disorders, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Summer Treatment Program for Pre-Kindergarteners and KindergartenersBehavioural
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)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: Summer Treatment Program for Pre-Kindergarteners and Kindergarteners; Behavioral: School Readiness Parenting Program (SRPP); Behavioral: Cognitive Behavioral Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, between 4 to 6 months after baseline (post treatment), and 12-months
Secondary outcomes (5)
Behavior Assessment System for Children
A widely used behavior checklist that taps emotional and behavioral domains of children's functioning. There are three parent versions: Preschool Form (ages 2-5, 134 total items), Child Form (ages 6-11, 160 total items), and Adolescent form (ages 12-21, 150 total items).
Measured: Baseline, post treatment, 12-months
Disruptive Behavior Disorders Rating Scale
Assesses for the presence of Attention-Deficit/Hyperactivity Disorder, Oppositional Defiant Disorder, or Conduct Disorder symptoms . On the DBD, parents are asked to provide ratings of (0) not at all, (1) just a little, (2) pretty much, or (3) very much for each symptom listed.
Measured: Baseline, post treatment, 12-months
Treatment Satisfaction Survey
Parents will complete a 40-item treatment satisfaction survey assessing their child's response to treatment, their attitudes towards the treatment format, and other related outcomes.
Measured: Post treatment
SRPP activities practice
Percentage of weekly activities completed as part of SRPP sessions
Measured: During/Post-treatment
Difficult Puzzle Lab Task - Early Parenting Coding System (EPCS)
Children's emotion dysregulation will be coded during the task via global codes that have been previously used in prior temperament studies.
Measured: Baseline, post treatment, 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start7 Feb 2023
- Primary completion29 May 2026
- Study completion29 May 2026
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paulo A. Graziano, PhD, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626750
- Sponsor's protocol ID
- IRB-23-0039
- Status last verified
- Oct 2025
- First submitted
- 28 Aug 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified summary data from the study will be shared with other researchers upon request and after completion of study.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Stress Management Strategies Within the School Readiness Parenting Program
- ClinicalTrials.gov ID
- NCT06626750
- Acronym / sponsor ID
- IRB-23-0039
- Conditions
- Parenting, Stress, Disruptive Behavior Disorder, Parent-Child Relations, ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 29 May 2026 (actual)
- Study completion
- 29 May 2026 (actual)
- First posted
- 4 Oct 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional School Readiness Parenting Program | Active comparator | Behavioral: Summer Treatment Program for Pre-Kindergarteners and Kindergarteners, Behavioral: School Readiness Parenting Program (SRPP)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). |
| School Readiness Parenting Program + Cognitive Behavioral Therapy | Experimental | Behavioral: Summer Treatment Program for Pre-Kindergarteners and Kindergarteners, Behavioral: School Readiness Parenting Program (SRPP), Behavioral: Cognitive Behavioral Therapy (CBT)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). |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Summer Treatment Program for Pre-Kindergarteners and KindergartenersChildren 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. | Behavioural | School Readiness Parenting Program + Cognitive Behavioral Therapy, Traditional School Readiness Parenting Program |
| 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. | Behavioural | School Readiness Parenting Program + Cognitive Behavioral Therapy, Traditional School Readiness Parenting Program |
| 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. | Behavioural | School Readiness Parenting Program + Cognitive Behavioral Therapy |
Primary outcome
Parent Stress Index (PSI)
Time frame: Baseline, between 4 to 6 months after baseline (post treatment), and 12-months
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.
Dyadic Parent-Child Interaction Coding System
Time frame: Baseline, between 4 to 6 months after baseline (post treatment), and 12-months
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.
Difficult Puzzle Lab Task - Early Parenting Coding System (EPCS)
Time frame: Baseline, between 4 to 6 months after baseline (post treatment), and 12-months
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.
Cognitive Behavioral Therapy Parent Quiz
Time frame: Baseline, between 4 to 6 months after baseline (post treatment), and 12-months
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.
5 secondary outcomes
Behavior Assessment System for Children
Time frame: Baseline, post treatment, 12-months
Disruptive Behavior Disorders Rating Scale
Time frame: Baseline, post treatment, 12-months
Treatment Satisfaction Survey
Time frame: Post treatment
SRPP activities practice
Time frame: During/Post-treatment
Difficult Puzzle Lab Task - Early Parenting Coding System (EPCS)
Time frame: Baseline, post treatment, 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified summary data from the study will be shared with other researchers upon request and after completion of study.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Summer Treatment Program for Pre-Kindergarteners and Kindergarteners, School Readiness Parenting Program (SRPP) and Cognitive Behavioral Therapy (CBT) in people with Parenting and Stress, run by Florida International 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 23 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Stress Index (PSI) (time frame: Baseline, between 4 to 6 months after baseline (post treatment), and 12-months). The study lists 4 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 23 Jul 2026.