Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-04-11 @ 6:00 PM
Study NCT ID:
NCT06626750
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-20
First Post:
2024-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Stress Management Strategies Within the School Readiness Parenting Program
Sponsor:
Florida International University
Organization:
Study Overview
Official Title:
Evaluating Stress Management Strategies Within the School Readiness Parenting Program
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: