Evaluating Stress Management Strategies Within the School Readiness Parenting Program (NCT06626750) | Clinical Trial Compass
CompletedNot Applicable
Evaluating Stress Management Strategies Within the School Readiness Parenting Program
United States123 participantsStarted 2023-02-07
Plain-language 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.
Who can participate
Age range
4 Years – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested stress management strategies within a parenting program for children with ADHD or disruptive behavior — since it's already completed, would it be worth asking whether the results are published and whether any of the stress management techniques from the program have been shown to help parents in situations like ours?
2The trial measured things like parent stress levels and how parents and children interact during challenging tasks — based on what was being studied, does this sound like the kind of support our family might benefit from, or would a different evidence-based parenting program be a better fit right now?
3Since this was a non-Phase trial focused on parenting strategies rather than a medication or medical procedure, how does it compare to standard recommended approaches for supporting parents of children with ADHD or disruptive behavior disorders?
4The program included cognitive behavioral therapy components for parents — is CBT-based parenting support something you'd recommend we pursue, and are there programs currently enrolling or already available that use similar approaches?
5Given that this trial has already completed recruitment, are there other active studies or community programs you know of that focus on stress management and parent-child interaction for families dealing with ADHD or disruptive behavior that we could explore together?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Parent Stress Index (PSI)
Timeframe: Baseline, between 4 to 6 months after baseline (post treatment), and 12-months
2
Dyadic Parent-Child Interaction Coding System
Timeframe: Baseline, between 4 to 6 months after baseline (post treatment), and 12-months
3
Difficult Puzzle Lab Task - Early Parenting Coding System (EPCS)
Timeframe: Baseline, between 4 to 6 months after baseline (post treatment), and 12-months
4
Cognitive Behavioral Therapy Parent Quiz
Timeframe: Baseline, between 4 to 6 months after baseline (post treatment), and 12-months