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临床试验/NCT06626750
NCT06626750已完成不适用

Evaluating Stress Management Strategies Within the School Readiness Parenting Program

Florida International University1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2023年2月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
123
试验地点
1
主要终点
Parent Stress Index (PSI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
4 Years 至 6 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

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).

干预措施: Summer Treatment Program for Pre-Kindergarteners and Kindergarteners (Behavioral)

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).

干预措施: School Readiness Parenting Program (SRPP) (Behavioral)

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).

干预措施: Summer Treatment Program for Pre-Kindergarteners and Kindergarteners (Behavioral)

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).

干预措施: School Readiness Parenting Program (SRPP) (Behavioral)

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).

干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)

结局指标

主要结局

Parent Stress Index (PSI)

时间窗: 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

时间窗: 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)

时间窗: 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

时间窗: 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.

次要结局

  • Behavior Assessment System for Children(Baseline, post treatment, 12-months)
  • Disruptive Behavior Disorders Rating Scale(Baseline, post treatment, 12-months)
  • Treatment Satisfaction Survey(Post treatment)
  • SRPP activities practice(During/Post-treatment)
  • Difficult Puzzle Lab Task - Early Parenting Coding System (EPCS)(Baseline, post treatment, 12-months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paulo A. Graziano, PhD

Professor

Florida International University

研究点 (1)

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