Assessing and Addressing Behaviors in Children With Hearing Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- Number of sessions attended by each enrolled parent
研究概览
简要总结
Purpose:
This study is a feasibility trial of an existing evidence-based behavioral parent training program with parents of preschool-aged children who were born deaf or hard of hearing (DHH).
The hypotheses of this study are (a) that a randomized control trial of the Family Check Up with this population will be feasible, (b) parents will rate the intervention as acceptable, and (c) a signal of effect will be observable among intervention group parents compared to controls for the following outcome variables: child behaviors, parenting behaviors, and parenting sense of competence.
详细描述
24 participants, comprising 6 parents and their preschool-aged child with a cochlear implant (CI; n=12) and 6 parents and their preschool-aged child with a hearing aid (HA; n=12) will be identified and recruited at routine clinic visits through university-affiliated hearing clinics. A dyad will consist of the child and his or her primary caregiver. Eligible participants will include children with clinically elevated behavior problems, as determined by having scored between the 70th and 90th percentiles on the Child Behavioral Checklist/1.5-5 (CBCL/1.5-5).
3 HA and 3 CI dyads will be randomized to the intervention group, and 3 HA and 3 CI dyads will be randomized to the control group. The intervention will consist of 3 Family Check-Up sessions within one month of baseline assessment. The control condition will consist of 3 behavioral placebo session within the same time frame, in which general information about healthy lifestyles will be presented. All intervention and control sessions will be delivered in the patients' usual hearing clinics. Each session will last between 60 and 90 minutes. One month post-intervention, all parent participants will complete post-test measures repeating baseline measures, plus acceptability ratings of the intervention.
Feasibility data will be collected via process measures of recruitment, retention, and session attendance. Acceptability will be measured with a parent-completed satisfaction survey. Measures of parenting behaviors, parent self-efficacy, parent-satisfaction, parent competence, child disruptive behaviors, parenting stress, and parental depression will also be piloted in preparation for a future study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent is age 18 years or older and the custodial guardian
- •The child is aged 3-5 years and lives full-time in the caregiver's home
- •The child has had a hearing aid or cochlear implant for at least 6 months and is currently being treated for hearing loss
- •The child scores above the 70th but below the 90th percentile on the externalizing subscale of the CBCL/1.5-575 (i.e., elevated level of disruptive behavior problems without clear need for specialized behavioral services)
- •Parent can speak, understand, and read English
排除标准
- •The child has been diagnosed with a severe developmental condition (e.g., extreme developmental delay, severe autism, or debilitating neurological conditions, for which this intervention may not be adequate or appropriate)
- •The parent already has accessed behavioral health services for the child
研究组 & 干预措施
Control Group
The control group will include 3 hearing aid (HA) and 3 cochlear implant (CI) caregiver-child dyads.
Parents in the control group will receive an initial assessment session followed by three behavioral placebo sessions followed by a post-placebo-intervention assessment. All sessions will be delivered in the patients' usual hearing clinics and will last between 60 and 90 minutes. One month post-intervention, participants will complete post-test measures repeating baseline measures, plus acceptability ratings of intervention.
干预措施: Behavioral Placebo (Behavioral)
Intervention Group
The intervention group will include 3 hearing aid (HA) and 3 cochlear implant (CI) caregiver-child dyads.
Intervention parents receive the initial assessment session followed by the 3-session Family Check Up Behavioral Parenting Training Program (BPT) within one month of baseline assessment followed by a post-intervention assessment. All sessions will be delivered in the patients' usual hearing clinics and will last between 60 and 90 minutes. One month post-intervention, participants will complete post-test measures repeating baseline measures, plus acceptability ratings of intervention.
干预措施: Family Check Up Behavioral Parenting Training Program (BPT) (Behavioral)
结局指标
主要结局
Number of sessions attended by each enrolled parent
时间窗: 3 months
次要结局
- Ability to recruit 12 parent-child dyas in the allotted time frame(10 months)
- Time required per participant to complete all instruments(Up to 3 hours)
- Proportion of missing data across all instruments and within each instrument(4 months)
- COACH fidelity rating form(10 months months)
- Proportions of each full instrument and interview that are successfully completed(4 months)
研究者
Matthew Bush, MD
Matthew Bush, MD, Assistant Professor, University of Kentucky
University of Kentucky