Behavioral Parent Training for Families With Deaf and Hard of Hearing Preschoolers
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 295
- 试验地点
- 1
- 主要终点
- Parenting Young Children (PARYC) Scale
研究概览
简要总结
Children who are deaf and hard of hearing (DHH) rarely receive behavioral interventions to prevent the long-term costly outcomes of behavior problems. This project will systematically adapt an evidence-based parent training intervention to increase its acceptability and relevance for parents of young DHH children. Effectiveness of the adapted intervention and its implementation with parents of young DHH children followed in "real world" hearing healthcare clinics will be assessed.
详细描述
Aim 1: This part of the study convened a Community Advisory Board for input on the study. CAB members were considered collaborators rather than research subjects. They provided no personal data for use in publications or other research dissemination efforts. No adverse event data related to the CAB were collected.
Aim 2: This part of the study involved qualitative interviews with parents and focus groups with stakeholders (speech-language pathologists, audiologists, and teachers of the Deaf) to guide the adaptation of the intervention. There was no intervention in this aim and it was not a clinical trial. No adverse event data related to the qualitative interviews were collected.
Aim 3: Please see Record NCT03483428 for details and results of Aim 3.
Aim 4: This part of the study was a randomized controlled trial of the adapted parent training intervention. Parents of DHH children were randomized to either receive the intervention or to a control condition.
Aim 5: This part of the study is collecting process data about how the intervention was delivered in Aim 4, as well as qualitative data regarding perspectives about the intervention from key stakeholders, including a subset of parents from Aim 4, the interventionists who delivered the intervention, and other stakeholders. There is no intervention in this aim and it is not a clinical trial. No adverse event data will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent is age 18 or older
- •Parent is custodial guardian of child
- •Parent can either speak/understand English or use American Sign Language
- •Parent lives in a state with an established referral network for parents of DHH children if additional services are needed
- •At baseline, child is between the ages of 3 and 6 years
- •At baseline, child lives majority of time in the parent/guardian's home
- •Child is deaf or hard of hearing
- •Child has used hearing aid(s), cochlear implant(s) and/or bone conduction device(s) for greater than 6 months
排除标准
- •Active child protective services case is open
- •Parent has already accessed behavioral health services for the child
- •Parent participated in formative research for this study
研究组 & 干预措施
Control
Parents are not offered the intervention but are not precluded from accessing other services for their young deaf and hard of hearing chidren.
Behavioral Parent Training
Parents are offered a evidence-based behavioral parent training intervention systematically adapted for parents of young deaf and hard of hearing children. The intervention is offered annually and includes up to 6 sessions each year.
干预措施: Parent Training Intervention (Behavioral)
结局指标
主要结局
Parenting Young Children (PARYC) Scale
时间窗: 6 months after parent baseline
parent self-report use of positive parenting strategies; score on a scale from 1 to 7, with higher scores indicating more positive parenting practices
Parenting Young Children (PARYC) Scale Total Score
时间窗: 6 months after parent baseline
On the Parenting Young Children (PARYC) scale, parents self-report use of positive parenting strategies by rating 21 specific parenting behaviors from 1 (not at all) to 7 (most of the time) based on how often in the past month they engaged in each parenting behavior. The PARYC Total Score is the sum of three subscale scores (Supporting Positive Behaviors, Setting Limits, Proactive Parenting) and can range from 21-147 with higher scores indicating more positive parenting practices.
次要结局
- Child Behavior Checklist (CBCL)(6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline)
- Parent Child Interaction System (PARCHISY)(12 months, 24 months, 36 months after parent baseline)
- Parent Motivation Inventory (PMI)(12 months, 24 months, 36 months after parent baseline)
- Hearing Aid Adherence Questionnaire(12 months, 24 months, 36 months after parent baseline)
- Beck Depression Inventory-II (BDI-II)(6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline)
- Change in Parenting Young Children scale (PARYC) scores over time(6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline)
- Parent Sense of Competence Scale (PSCS)(6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline)
- Therapy Attitude Inventory (TAI)(6 months, 18 months, 30 months after parent baseline)
- Change in Parenting Young Children Scale (PARYC) Total Scores Over Time(Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment)
- Change in Parenting Young Children Scale (PARYC) Supporting Positive Behavior Subscale Scores Over Time(Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment)
- Change in Parenting Young Children Scale (PARYC) Setting Limits Subscale Scores Over Time(Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment)
- Change in Parenting Young Children Scale (PARYC) Proactive Parenting Subscale Scores Over Time(Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment)
- Child Behavior Checklist (CBCL) Total Problems T-Score(Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment)
- Child Behavior Checklist (CBCL) Internalizing Problems T-Score(Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment)
- Child Behavior Checklist (CBCL) Externalizing Problems T-Score(Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment)
- Parent Sense of Competence Scale (PSCS) Total Score(Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment.)
- Parent Sense of Competence Scale (PSCS) Self-efficacy Score(Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment)
- Parent Sense of Competence Scale (PSCS) Satisfaction Score(Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment)
- Beck Depression Inventory-II (BDI-II)(Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment)
- Parent Child Interaction System (PARCHISY) - Parent Positive Control(Every 6 months from baseline to up to 18 months after baseline)
- Parent Child Interaction System (PARCHISY) - Parent Negative Control(Every 6 months from baseline to up to 18 months after baseline)
- Parent Child Interaction System (PARCHISY) - Parent Positive Affect(Every 6 months from baseline to up to 18 months after baseline)
- Parent Child Interaction System (PARCHISY) - Parent Negative Affect(Every 6 months from baseline to up to 18 months after baseline)
- Parent Child Interaction System (PARCHISY) - Child Positive Affect(Every 6 months from baseline to up to 18 months after baseline)
- Parent Child Interaction System (PARCHISY) - Child Negative Affect(Every 6 months from baseline to up to 18 months after baseline)
- Parent Child Interaction System (PARCHISY) - Child On-Task(Every 6 months from baseline to up to 18 months after baseline)
- Parent Child Interaction System (PARCHISY) - Child Noncompliance(Every 6 months from baseline to up to 18 months after baseline)
- Parent Child Interaction System (PARCHISY) - Conflict(Every 6 months from baseline to up to 18 months after baseline)
- Parent Motivation Inventory (PMI) Total Score(Annually from 12 months after baseline up to 36 months after baseline)
- Parent Motivation Inventory (PMI) Desire for Change Subscale(Annually from 12 months after baseline up to 36 months after baseline)
- Parent Motivation Inventory (PMI) Readiness to Change Subscale(Annually from 12 months after baseline up to 36 months after baseline)
- Parent Motivation Inventory (PMI) Perceived Ability to Change Subscale(Annually from 12 months after baseline up to 36 months after baseline)
- Hearing Aid Adherence Questionnaire(Every 12 months from completion of baseline assessment up to 36 months after baseline assessment)
- Therapy Attitude Inventory (TAI)(Annually from 6 months after baseline up to 30 months after baseline)
研究者
Christina Studts
Professor
University of Kentucky