Premature Birth Clinical Trial
— ezParentOfficial title:
Parent Training for Parents of Toddlers Born Very Premature: A Factorial Design to Test Web Delivery and Telephone Coaching
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: 1. 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. 2. 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. 3. 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.
Status | Recruiting |
Enrollment | 490 |
Est. completion date | October 1, 2025 |
Est. primary completion date | October 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Months and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Rush University Children's Hospital | Chicago | Illinois |
United States | Nationwide Children's Hospital | Columbus | Ohio |
United States | Ohio State University College of Nursing | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University | Klein Buendel, Inc., Nationwide Children's Hospital, Rush University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | General Demographics and Income | Demographics (e.g., age, race/ethnicity, household structure) will be collected using a 32-item demographic inventory. | Baseline | |
Other | Neighborhood and community characteristics | 9 items from the National Survey of Children's Health. Questions include perceived neighborhood social support, condition, and safety | Baseline | |
Other | Confusion, Hubbub, and Order Scale (CHAOS) | The CHAOS is 15-items and is designed to assess the level of environmental confusion and disorganization in the home. Scoring is on a 4-point scale (1 = very much to 4 = not at all like your own home). A total score represents the level of chaos and disorganization in the home environment. Higher scores indicate greater home chaos and disorganization. | Baseline | |
Other | Confusion, Hubbub, and Order Scale (CHAOS) | The CHAOS is 15-items and is designed to assess the level of environmental confusion and disorganization in the home. Scoring is on a 4-point scale (1 = very much to 4 = not at all like your own home). A total score represents the level of chaos and disorganization in the home environment. Higher scores indicate greater home chaos and disorganization. | 3-month post-baseline | |
Other | Confusion, Hubbub, and Order Scale (CHAOS) | The CHAOS is 15-items and is designed to assess the level of environmental confusion and disorganization in the home. Scoring is on a 4-point scale (1 = very much to 4 = not at all like your own home). A total score represents the level of chaos and disorganization in the home environment. Higher scores indicate greater home chaos and disorganization. | 6-month post-baseline | |
Other | Confusion, Hubbub, and Order Scale (CHAOS) | The CHAOS is 15-items and is designed to assess the level of environmental confusion and disorganization in the home. Scoring is on a 4-point scale (1 = very much to 4 = not at all like your own home). A total score represents the level of chaos and disorganization in the home environment. Higher scores indicate greater home chaos and disorganization. | 12-month post-baseline | |
Other | Vineland Adaptive Behavior Scale (3rd edition) | Communication (receptive and expressive) and Socialization (interpersonal, play and leisure, and coping skills) scales of the Vineland-3 will be used to screen for study eligibility and evaluate developmental progress. The Parent/Caregiver Form asks about home and family-life behavior and parents respond to a series of questions about their child's abilities on a scale of 0=never; 1=sometimes; 2=usually or often and stop after they have given five scores of 0 in a row. This scale is used for eligibility screening (parents will not be included if: the 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) | Eligibility screening | |
Other | Perceived Stress Scale | Measures the degree to which situations in one's life are appraised as stressful. 10-items, scored on a 5-point scale ( 0 - never 1 - almost never 2 - sometimes 3 - fairly often 4 - very often); higher scores indicate higher perceived stress. | Baseline | |
Other | Perceived Stress Scale | Measures the degree to which situations in one's life are appraised as stressful. 10-items, scored on a 5-point scale ( 0 - never 1 - almost never 2 - sometimes 3 - fairly often 4 - very often); higher scores indicate higher perceived stress. | 3-month post-baseline | |
Other | Perceived Stress Scale | Measures the degree to which situations in one's life are appraised as stressful. 10-items, scored on a 5-point scale ( 0 - never 1 - almost never 2 - sometimes 3 - fairly often 4 - very often); higher scores indicate higher perceived stress. | 6-month post-baseline | |
Other | Perceived Stress Scale | Measures the degree to which situations in one's life are appraised as stressful. 10-items, scored on a 5-point scale ( 0 - never 1 - almost never 2 - sometimes 3 - fairly often 4 - very often); higher scores indicate higher perceived stress. | 12-month post-baseline | |
Primary | Change in Parenting Self-efficacy and Competence (Parenting Sense of Competence Scale (PSOC)) | 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. | baseline; 3-month, 6-month, 12-month post-baseline | |
Primary | Change in observed parent-child interaction and emotional connection (Welch Emotional Connection Scale (WECS) | 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). | 3-month post baseline | |
Primary | Change in Child Behavior (Eyberg Child Behavior Inventory (ECBI)) | 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. | baseline; 3-month, 6-month, 12-month post-baseline | |
Primary | Change in Parenting Behaviors (Parent Questionnaire (PQ)) | 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. | baseline; 3-month, 6-month, 12-month post-baseline | |
Primary | Change in Parenting Stress (Parenting Stress Index-Short Form (PSI-SF)) | 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. | baseline; 3-month, 6-month, 12-month post-baseline | |
Primary | Change in Child Behavior (Child Behavior Checklist 1½-5 (CBCL)) | 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). | baseline; 3-month, 6-month, 12-month post-baseline | |
Primary | Change in Parenting Style and Behavior (Parenting Style Dimensions Questionnaire) | 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. | baseline; 3-month, 6-month, 12-month post-baseline | |
Secondary | Program satisfaction | The 22-item satisfaction survey includes: usefulness of program in managing child's behavior (3-items), acceptability of treatment format procedures (3-items), acceptability of program content (4-items), perceived program impact on participant as a parent (8-items) and helpfulness of intervention as an immediate resource for behavioral concerns (4-items). | 3-month post baseline follow up | |
Secondary | Intervention engagement | Metrics include: time stamps of all parent use of the program. Data is all accessible through digital tracking. | up to 3-months post-baseline (during intervention period) | |
Secondary | Parent engagement - coaching calls | Metrics include: number of completed coaching phone calls, phone call attempts, and length of calls. Parents and coach will complete study developed process evaluation of parent engagement in calls and parent-coach relationship quality. | up to 3-months post-baseline (during intervention period) |
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