Evaluating Stress Management Strategies Within the School Readiness Parenting Program

Not Applicable

Recruiting

• Conditions: Parenting; Stress; Disruptive Behavior Disorder; Parent-Child Relations; ADHD

• Registration Number: NCT06626750
• Lead Sponsor: Florida International University

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.

Study Timeline

• Study Start: 2023-02-07
• Study First Submitted: 2024-08-28
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-02
• Last Update Submitted: 2024-10-02
• Study First Posted: 2024-10-04
• Last Update Posted: 2024-10-04
• Primary Completion: 2026-05-29
• Study Completion: 2026-05-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Parent Stress Index (PSI)	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	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)	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	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.

Secondary Outcome Measures

Name	Time	Method
Behavior Assessment System for Children	Baseline, post treatment, 12-months	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).
Disruptive Behavior Disorders Rating Scale	Baseline, post treatment, 12-months	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.
Treatment Satisfaction Survey	Post treatment	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.
SRPP activities practice	During/Post-treatment	Percentage of weekly activities completed as part of SRPP sessions
Difficult Puzzle Lab Task - Early Parenting Coding System (EPCS)	Baseline, post treatment, 12-months	Children's emotion dysregulation will be coded during the task via global codes that have been previously used in prior temperament studies.

Trial Locations

Locations (1)

Florida International University; 🇺🇸 Miami, Florida, United States