Parent Training for Parents of Toddlers Born Very Premature: A Factorial Design to Test Web Delivery and Telephone Coaching
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 452
- 试验地点
- 3
- 主要终点
- Change in Parenting Self-efficacy and Competence (Parenting Sense of Competence Scale (PSOC))
研究概览
简要总结
The purpose of the study is to test the effects of the ezParent (web-based parent training program) intervention and telephone coaching calls (coach) on parent and child outcomes after 3-, 6-, and 12-months. Parents (n=220) will be randomized using a 2 x 2 factorial design to: (1) ezParent+coach, (2) ezParent, (3) Active Control+coach, or (4) Active control. The investigators will address these aims:
- Determine the independent and combined effects of ezParent and coaching calls on parent outcomes. H1: The ezParent and ezParent+coach groups will report greater improvements in parenting skills and self-efficacy and reductions in harsh and negative discipline; and exhibit observed improvements in parent-child emotional connection vs. active control H2: There will be a synergistic effect of ezParent and coaching calls on parent outcomes such that ezParent+coach will provide greater benefit than the sum of the main effects of ezParent or coaching calls.
- Determine the independent and combined effects of ezParent and coaching calls on child outcomes. H3: The ezParent and ezParent+coach groups will report greater reductions in child behavior problems vs. active control. H4: There will be a synergistic effect of ezParent and coaching calls on child outcomes such that ezParent+coach will provide greater benefit than the sum of the main effects of ezParent or coaching calls.
- Determine differences in ezParent engagement with and without coaching calls. Engagement will be assessed by frequency (the number of times parents use the program), activity (proportion of material completed), and duration (amount of time parents use the program). H5: Relative to the ezParent only group, the ezParent+coach group will exhibit higher engagement with the ezParent.
详细描述
The purpose of this study is to test the separate and combined effects of the ezParent behavioral parent training (BPT) program and coaching calls on parent and former very preterm (VPT) child outcomes. Currently, there is no effective, accessible BPT intervention for parents of former VPT infants. The goal is to develop a widely accessible and effective form of BPT delivery to address the unmet and unique needs of parents of VPT children. This is a critical gap, because without such tailored intervention, early behavior problems will persist and impair individual and family functioning over the long term.
A 2x2 factorial randomized design will be used with parent-child dyads (n=220) of children age 20-30 months corrected age (CA) who were born VPT (<32 weeks gestational age). Parent-child dyads will be randomized into one of four groups: (1) ezParent+coach, (2) ezParent, (3) Active Control+coach, or (4) Active Control. Parent and child outcome data will be collected at 4 time points (baseline; 3 months post-baseline; 6 months post-baseline; 12 months post-baseline).
The specific aims are to determine the independent and combined effects of ezParent and coaching calls on parent outcomes and child outcomes and to identify differences in ezParent engagement with and without coaching calls. Study hypotheses are:
- Parents in the ezParent and ezParent+coach groups will report greater improvements in parenting skills and self-efficacy and reductions in harsh and negative discipline; and exhibit observed improvements in parent-child emotional connection vs. active control.
- There will be a synergistic effect of ezParent and coaching calls on parent outcomes such that ezParent+coach will provide greater benefit than the sum of the main effects of ezParent or coaching calls.
- Parents in the ezParent and ezParent+coach groups will report greater reductions in child behavior problems vs. active control.
- There will be a synergistic effect of ezParent and coaching calls on child outcomes such that ezParent+coach will provide greater benefit than the sum of the main effects of ezParent or coaching calls.
- Relative to the ezParent only group, the ezParent+coach group will exhibit higher engagement with the ezParent.
Parent-child dyads (n=220) will be recruited for this study from 2 large pediatric academic medical centers that care for large and diverse populations of children born preterm (Nationwide Children's Hospital (NCH), Columbus, OH, and Rush University Medical Center (RUMC), Chicago IL). Recruitment will be coordinated through RUMC and NCH's NICU follow-up clinics. Recruitment methods include: (a) in person recruitment by trained Research Assistants (RAs) at scheduled NICU follow up clinic appointments, (b) study information provided by NICU follow up clinics, and (c) direct mailings (email and postal) to parents with children in the eligible age range generated through the NICU follow up clinics via listservs and patient lists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
RAs collecting baseline data are blind to the participant initial randomization condition until all surveys are completed. Once the parent participant has been randomized to their initial condition (e.g., ezParent, ezParent+coach, control, control+coach), they will be provided specific instructions based on their condition.
入排标准
- 年龄范围
- 20 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent or legal guardian of a child that was very preterm (VPT) (gestational age < 32 weeks) between 20 - 30 months corrected age
- •parent is English speaking
- •parent has a smartphone, tablet, or computer with Wi-Fi or wireless access to receive the digital intervention component for their assigned group.
排除标准
- •- child demonstrates a profound developmental and adaptive skill impairment (standard score of 55, 3 SDs below the M, below the 1st percentile) as reported by parents on the Vineland Adaptive Behavior Scale (3rd edition) Communication or Socialization Index.
研究组 & 干预措施
ezParent+ coach
ezParent - Program is a 6-module digital adaptation of the group-based Chicago Parent Program, 12-session program for parents of young children. A core objective of the CPP is to promote positive parenting behavior - for example, teaching parents to limit the amount of attention given to negative behaviors and reward the positive - to decrease child behavior problems and increase child prosocial behavior.
Coach - The purpose of the brief weekly telephone coaching calls is to provide parents with an opportunity to receive clarification of intervention content, encouragement and reinforcement of intervention completion, and support tailoring of intervention content for their child. The coaching calls will be guided by a semi-structured script aimed at supporting parent learning and motivation. Coaches will be trained in active and empathic listening and problem solving techniques to facilitate learning and support of parents.
干预措施: ezParent (Behavioral)
ezParent+ coach
ezParent - Program is a 6-module digital adaptation of the group-based Chicago Parent Program, 12-session program for parents of young children. A core objective of the CPP is to promote positive parenting behavior - for example, teaching parents to limit the amount of attention given to negative behaviors and reward the positive - to decrease child behavior problems and increase child prosocial behavior.
Coach - The purpose of the brief weekly telephone coaching calls is to provide parents with an opportunity to receive clarification of intervention content, encouragement and reinforcement of intervention completion, and support tailoring of intervention content for their child. The coaching calls will be guided by a semi-structured script aimed at supporting parent learning and motivation. Coaches will be trained in active and empathic listening and problem solving techniques to facilitate learning and support of parents.
干预措施: Coaching calls (Behavioral)
ezParent
ezParent - Program is a 6-module digital adaptation of the group-based Chicago Parent Program, 12-session program for parents of young children. A core objective of the CPP is to promote positive parenting behavior - for example, teaching parents to limit the amount of attention given to negative behaviors and reward the positive - to decrease child behavior problems and increase child prosocial behavior.
干预措施: ezParent (Behavioral)
Active Control+coach
Active Control - The active control is an adaptation of a digital application used in our previous study (HS024273). The program will include general information typically provided during well-child or NICU follow up visits but unrelated to parenting or child development and behavior. Six topic areas are: Immunizations, Common Childhood Illnesses, Nutrition, Dental Health, and Indoor and Outdoor Injury Prevention/Safety. The program includes digital handouts, websites, and resources provided to parents of children in this age group.
Coach - The purpose of the brief weekly telephone coaching calls is to provide parents with an opportunity to receive clarification of intervention content, encouragement and reinforcement of intervention completion, and support tailoring of intervention content for their child. The coaching calls will be guided by a semi-structured script aimed at supporting parent learning and motivation.
干预措施: Coaching calls (Behavioral)
Active Control+coach
Active Control - The active control is an adaptation of a digital application used in our previous study (HS024273). The program will include general information typically provided during well-child or NICU follow up visits but unrelated to parenting or child development and behavior. Six topic areas are: Immunizations, Common Childhood Illnesses, Nutrition, Dental Health, and Indoor and Outdoor Injury Prevention/Safety. The program includes digital handouts, websites, and resources provided to parents of children in this age group.
Coach - The purpose of the brief weekly telephone coaching calls is to provide parents with an opportunity to receive clarification of intervention content, encouragement and reinforcement of intervention completion, and support tailoring of intervention content for their child. The coaching calls will be guided by a semi-structured script aimed at supporting parent learning and motivation.
干预措施: Active Control (Behavioral)
Active Control
The active control is an adaptation of a digital application used in our previous study (HS024273). The program will include general information typically provided during well-child or NICU follow up visits but unrelated to parenting or child development and behavior. Six topic areas are: Immunizations, Common Childhood Illnesses, Nutrition, Dental Health, and Indoor and Outdoor Injury Prevention/Safety. The program includes digital handouts, websites, and resources provided to parents of children in this age group. Parents will be instructed to review each topic over 10-weeks (~1 topic every 1.5 weeks) to match the dose and timing of contact that the intervention groups will receive.
干预措施: Active Control (Behavioral)
结局指标
主要结局
Change in Parenting Self-efficacy and Competence (Parenting Sense of Competence Scale (PSOC))
时间窗: baseline; 3-month, 6-month, 12-month post-baseline
The Parenting Sense of Competence Scale (PSOC) has 17-items, with 2 subscales: satisfaction (person's liking of the parenting role) and efficacy (person's perceived competence in the parenting role). Scoring is on a 6-point scale (1 = strongly disagree to 6 = strongly agree). Higher scores indicate a better outcome (higher perceived parenting satisfaction and efficacy). The PSOC is correlated with other measures of family life and child behavior, and the satisfaction subscale is strongly correlated with measures of child behavior, parent well-being, and parenting style.
Change in Parenting Behaviors (Parent Questionnaire (PQ))
时间窗: baseline; 3-month, 6-month, 12-month post-baseline
Follow-through subscale from the Parent Questionnaire (PQ. The follow-through subscale has 6-items and is scored on a 5-point scale related to parents' perception of how they perceive their behavior in following through on instructions and discipline. Higher scores indicate a better outcome.
Change in observed parent-child interaction and emotional connection (Welch Emotional Connection Scale (WECS)
时间窗: 3-month post baseline
WECS is an observational instrument for measuring key indicators of parent-child dyadic emotional connection (attraction, vocal communication, facial communication, and sensitivity/reciprocity) and is a construct of early relational health (ERH).
Change in Child Behavior (Eyberg Child Behavior Inventory (ECBI))
时间窗: baseline; 3-month, 6-month, 12-month post-baseline
The Eyberg Child Behavior Inventory (ECBI) is a 36-item scale designed to measure the presence and intensity of problem behavior. Each item is measured on two scales: the Problem Scale (dichotomous) and Intensity Scale (7-point). Higher scores indicate a worse outcome (parent report of higher problem behaviors).The ECBI and CBCL are valid measure of child behavior problems, with established convergent validity across racial and ethnic populations and economically and linguistically diverse samples.
Change in Parenting Stress (Parenting Stress Index-Short Form (PSI-SF))
时间窗: baseline; 3-month, 6-month, 12-month post-baseline
A self-report screening tool that identify the sources and different types of stress that come with parenting. Parents report their level of agreement with 36 items. There are three subscales: parental distress, parent-child dysfunctional interaction, and difficult child. A total stress score is calculated that indicates the overall level of stress a person is feeling in their role as a parent. Higher scores indicate a worse outcome (higher parenting stress). The PSI-SF is a valid measure of parenting stress in multicultural samples and for parents from lower socioeconomic groups.
Change in Child Behavior (Child Behavior Checklist 1½-5 (CBCL))
时间窗: baseline; 3-month, 6-month, 12-month post-baseline
The Child Behavior Checklist 1½-5 (CBCL) is a 99-item parent-report measure of frequencies of problem behaviors of children aged 1½ - 5. Two scales (externalizing (disruptive behavior problems, aggression, and hyperactivity) and Internalizing (anxiety, inhibition, depression, and social withdrawal) are rated on a 3- point scale (0 = not true; 1 = somewhat or sometimes true; and 2 = very true or often true). The CBCL is a valid assessment of behavior among former VPT infants. Higher scores indicate a worse outcome (higher child behavior problems).
Change in Parenting Style and Behavior (Parenting Style Dimensions Questionnaire)
时间窗: baseline; 3-month, 6-month, 12-month post-baseline
The PSDQ is a 32-item questionnaire that is grouped into three styles and seven dimensions of parenting behaviors and styles. Parents respond to a 5-point scale (1 = never; 2= once in a while; 3= about half of the time; 4= very often; 5 = always). Scores are grouped to identify parenting style and dimensions, based on scores.
次要结局
- Program satisfaction(3-month post baseline follow up)
- Intervention engagement(up to 3-months post-baseline (during intervention period))
- Parent engagement - coaching calls(up to 3-months post-baseline (during intervention period))
研究者
Susie Breitenstein
Professor, Associate Dean for Research
Ohio State University