Clinical trial NCT06626750: Evaluating Stress Management Strategies Within the School Readiness Parenting Program
Official title: Evaluating Stress Management Strategies Within the School Readiness Parenting Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parenting
Stress
Disruptive Behavior Disorder
Parent-Child Relations
ADHD
Lead sponsor: Florida International University
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Parent Stress Index (PSI)
timeFrame: Baseline, between 4 to 6 months after baseline (post treatment), and 12-months
measure: Dyadic Parent-Child Interaction Coding System
timeFrame: Baseline, between 4 to 6 months after baseline (post treatment), and 12-months
measure: Difficult Puzzle Lab Task - Early Parenting Coding System (EPCS)
timeFrame: Baseline, between 4 to 6 months after baseline (post treatment), and 12-months
measure: Cognitive Behavioral Therapy Parent Quiz
timeFrame: Baseline, between 4 to 6 months after baseline (post treatment), and 12-months
Secondary outcomes:
measure: Behavior Assessment System for Children
timeFrame: Baseline, post treatment, 12-months
measure: Disruptive Behavior Disorders Rating Scale
timeFrame: Baseline, post treatment, 12-months
measure: Treatment Satisfaction Survey
timeFrame: Post treatment
measure: SRPP activities practice
timeFrame: During/Post-treatment
measure: Difficult Puzzle Lab Task - Early Parenting Coding System (EPCS)
timeFrame: Baseline, post treatment, 12-months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University
state: Florida
Study officials:
References: