Parent-Child Interaction Therapy (PCIT) for Children With Traumatic Brain Injury (TBI): A Stepped-Care Model
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in caregiver-perceived child behavior problems as measured by the Eyberg Child Behavior Inventory (ECBI) problem scale
研究概览
简要总结
The purpose of this study is to understand how a stepped-care model of Parent-Child Interaction Therapy (Step-Up PCIT) addresses child behavioral problems among children between the ages of 2 and 7 with a traumatic brain injury (TBI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child Inclusion Criteria:
- •Child is between the ages of 2 and 7
- •Child has a mild to moderate TBI
- •Primary Caregiver Inclusion Criteria:
- •Primary caregiver is 18 years or older
- •Primary caregiver speaks and reads in either English or Spanish
排除标准
- •- Children with major sensory impairments (e.g., deafness, blindness)
- •Primary Caregiver Exclusion Criteria:
- •- Primary caregiver with major sensory impairments (e.g., deafness, blindness)
研究组 & 干预措施
PCIT Group
Participants in this group will receive the PCIT intervention for up to 5 weeks.
干预措施: PCIT (Behavioral)
结局指标
主要结局
Change in caregiver-perceived child behavior problems as measured by the Eyberg Child Behavior Inventory (ECBI) problem scale
时间窗: Baseline and week 5
The ECBI questionnaire will be used to evaluate the number of behavioral problems and the frequency of their occurrence before and after the intervention program. ECBI provides a list of 36 problem behaviors commonly reported by parents. The inventory assesses behavior on two dimensions: 1) the frequency of the behavior; 2) whether parents consider it a problem. The frequency ratings range from 1 (never) to 7 (always), and are summed up to arrive at an overall problem behavior Intensity Score, ranging from 36 to 252. Higher score means more behavioral problems.
Change in parent stress as measured by the Parenting Stress Index Fourth Edition Short Form (PSI-SF) total score
时间窗: Baseline and week 5
PSI-4-SF assesses the parents stress level. PSI-4-SF contains 36 items: 12 items for Parental Stress (PS), 12 items for Parent-Child Dysfunctional Interaction (P-CDI), and 12 items for Difficult Child (DC).The normal range for scores is within the 16th to 84th percentiles.Scores in the 85th to 89th percentile are considered high, and scores in the 90th percentile or higher are considered clinically significant.
Change in how the caregiver perceptions about how it is to care for the child as measured by the Parenting Stress Index Fourth Edition Short Form (PSI-SF) Difficult Child (DC) score
时间窗: Baseline and week 5
PSI-4-SF assesses the parents stress level.PSI-4-SF contains 36 items: 12 items for Parental Stress (PS) , 12 items for Parent-Child dysfunctional Interaction (P-CDI), and 12 items for Difficult Child (DC).The normal range for scores is within the 16th to 84th percentiles.Scores in the 85th to 89th percentile are considered high,and scores in the 90th percentile or higher are considered clinically significant.
Number of week homework was completed by the caregiver
时间窗: Up to 5 weeks
Number of week homework was completed by the caregiver
Change in parenting skills as measured by the Dyadic Parent-Child Interaction Coding System-Fourth Edition (DPIC-IV)
时间窗: Baseline and week 5
The Dyadic Parent-Child Interaction Coding System-4th Ed is a structured behavioral observation coding system assessing caregiver-child interactions. Observed parenting behaviors will be coded during a 5-min parent-child play session with a tablet with educational apps and combined into two categories of positive (praises, behavior descriptions, and reflections) and negative (questions, commands, and negative talk) verbalizations, reflecting behaviors caregivers are taught to use and avoid in PCIT. The higher the score the higher quality the parenting behavior.
Acceptability of Intervention Measure (AIM)
时间窗: Up to 5 weeks
The Likert scale has 4 items. The scores will be summed to provide a total score. Scores range from completely disagree to completely agree.
Feasibility of Intervention Measure (FIM)
时间窗: Up to 5 weeks
The Likert scale has 4 items. The scores will be summed to provide a total score. Scores range from completely disagree to completely agree.
Change in parent stress as measured by the Parenting Stress Index Fourth Edition Short Form (PSI-SF) Parent Stress (PS) score
时间窗: Baseline and week 5
PSI-4-SF assesses the parents stress level.PSI-4-SF contains 36 items: 12 items for Parental Stress (PS) , 12 items for Parent-Child Dysfunctional Interaction (P-CDI), and 12 items for Difficult Child (DC).The normal range for scores is within the 16th to 84th percentiles.Scores in the 85th to 89th percentile are considered high, and scores in the 90th percentile or higher are considered clinically significant.
Change in parent-child dysfunctional interaction as measured by the Parenting Stress Index Fourth Edition Short Form (PSI-SF) Parent-Child Dysfunctional Interaction (P-CDI) score
时间窗: Baseline and week 5
PSI-4-SF assesses the parents stress level.PSI-4-SF contains 36 items: 12 items for Parental Stress (PS) , 12 items for Parent-Child Dysfunctional Interaction (P-CDI), and 12 items for Difficult Child (DC).The normal range for scores is within the 16th to 84th percentiles.Scores in the 85th to 89th percentile are considered high, and scores in the 90th percentile or higher are considered clinically significant.
Treatment satisfaction as measured by the Therapist Attitude Inventory (TAI)
时间窗: Up to 5 weeks
TAI is a valid index of consumer satisfaction for participants in behavioral parent training (BPT). Items are rated on a scale from one (indicating treatment dissatisfaction or lack of improvement) to five (indicating satisfaction with treatment and improvement). Parents will complete this form after the last session of the BPT program. BPT consists of 11 items that are scored on a 5-point Likert scale. The total score range is 11-55; the higher the score, the greater the satisfaction
Number of modules completed by the caregiver
时间窗: Up to 5 weeks
Number of modules completed by the caregiver
Intervention Appropriateness Measure (IAM)
时间窗: Up to 5 weeks
The Likert scale has 4 items. The scores will be summed to provide a total score. Scores range from completely disagree to completely agree.
Change in child behavior problem frequency and severity as measured by the Eyberg Child Behavior Inventory (ECBI) intensity scale
时间窗: Baseline and week 5
The ECBI questionnaire will be used to evaluate the number of behavioral problems and the frequency of their occurrence before and after the intervention program. ECBI provides a list of 36 problem behaviors commonly reported by parents. The inventory assesses behavior on two dimensions: 1) the frequency of the behavior; 2) whether parents consider it a problem. The frequency ratings range from 1 (never) to 7 (always), and are summed up to arrive at an overall problem behavior Intensity Score, ranging from 36 to 252. Higher score means more behavioral problems.
次要结局
- Change in family functioning as measure by the General Functioning (GF) Scale(Baseline and week 5)
- Change in child's peer relationship problems as measured by the Strengths and Difficulties Questionnaire (SDQ) peer relationship problems scale(Baseline and week 5)
- Change in child's functioning as measured by the Strengths and Difficulties Questionnaire (SDQ)(Baseline and week 5)
- Change in child's hyperactivity/inattention as measured by the Strengths and Difficulties Questionnaire (SDQ) hyperactivity/inattention scale(Baseline and week 5)
- Change in child's conduct problems as measured by the Strengths and Difficulties Questionnaire (SDQ) conduct problems scale(Baseline and week 5)
- Change in child's emotional symptoms as measured by the Strengths and Difficulties Questionnaire (SDQ) emotional symptoms scale(Baseline and week 5)
- Change in child's prosocial behaviors as measured by the Strengths and Difficulties Questionnaire (SDQ) prosocial behavior scale(Baseline and week 5)
研究者
Dainelys Garcia
Associate Professor of Clinical Pediatrics
University of Miami
