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Parent Training for Parents of Toddlers Born Very Premature: (ezParent)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05217615
Recruitment Status : Recruiting
First Posted : February 1, 2022
Last Update Posted : February 3, 2023
Sponsor:
Collaborators:
Rush University Medical Center
Nationwide Children's Hospital
Klein Buendel, Inc.
Information provided by (Responsible Party):
Susie Breitenstein, Ohio State University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Parenting Problem Behavior Premature Birth Parenting Intervention Behavioral: ezParent Behavioral: Coaching calls Behavioral: Active Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 490 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 2x2 Factorial Design
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Parent Training for Parents of Toddlers Born Very Premature: A Factorial Design to Test Web Delivery and Telephone Coaching
Actual Study Start Date : August 3, 2022
Estimated Primary Completion Date : October 1, 2025
Estimated Study Completion Date : October 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

Arm Intervention/treatment
Experimental: 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.

Behavioral: ezParent
The ezParent Program is a 6-module web-based adaptation of the group-based Chicago Parent Program (CPP). ezParent uses multiple strategies to promote skill development in parents. Each module includes (a) video narrator descriptions of parenting strategies, (b) video vignettes of parents and children as examples of how parenting strategies work, (c) questions following each vignette for parents to reflect upon, (d) interactive activities for parents to complete, (e) knowledge questions to assess parent understanding of the strategies, and (f) practice assignments. To tailor to the former VPT population, developmental tips are included. Parents are instructed to complete the 6 modules over 10-weeks, approximately 1 module every 1.5 weeks. At the end of each module, parents receive a practice assignment linked to the module content. To encourage and support program completion, parents receive automated text messages and badges.

Behavioral: Coaching calls
The purpose of the brief (~15 min) telephone coaching calls is to provide parents with clarification of program content, encouragement and reinforcement of program completion, and support tailoring of intervention content (ezParent or Active Control)for their child. Coaching calls are guided by a semi-structured script aimed at supporting parent learning and motivation. Calls will be scheduled every week for 10 weeks. Each call will include an opportunity for parents to identify and discuss:(a) questions regarding the materials and content received in their respective groups,(b) identification of potential barriers and strategies to overcome barriers for completion of intervention (ezParent or control) content in their respective group, and (c)follow up on discussion points from previous calls. In both conditions, coaches will have access to a web-based usage portal to guide the discussion.

Experimental: 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.
Behavioral: ezParent
The ezParent Program is a 6-module web-based adaptation of the group-based Chicago Parent Program (CPP). ezParent uses multiple strategies to promote skill development in parents. Each module includes (a) video narrator descriptions of parenting strategies, (b) video vignettes of parents and children as examples of how parenting strategies work, (c) questions following each vignette for parents to reflect upon, (d) interactive activities for parents to complete, (e) knowledge questions to assess parent understanding of the strategies, and (f) practice assignments. To tailor to the former VPT population, developmental tips are included. Parents are instructed to complete the 6 modules over 10-weeks, approximately 1 module every 1.5 weeks. At the end of each module, parents receive a practice assignment linked to the module content. To encourage and support program completion, parents receive automated text messages and badges.

Active Comparator: 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.

Behavioral: Coaching calls
The purpose of the brief (~15 min) telephone coaching calls is to provide parents with clarification of program content, encouragement and reinforcement of program completion, and support tailoring of intervention content (ezParent or Active Control)for their child. Coaching calls are guided by a semi-structured script aimed at supporting parent learning and motivation. Calls will be scheduled every week for 10 weeks. Each call will include an opportunity for parents to identify and discuss:(a) questions regarding the materials and content received in their respective groups,(b) identification of potential barriers and strategies to overcome barriers for completion of intervention (ezParent or control) content in their respective group, and (c)follow up on discussion points from previous calls. In both conditions, coaches will have access to a web-based usage portal to guide the discussion.

Behavioral: Active Control
The active control is an adaptation of a web-based application developed in our previous study (R01-HS024273). The program will include general information typically provided during well-child or NICU follow up visits. Six topic areas are: Immunizations, Common Childhood Illnesses, Nutrition, Dental Health, and Indoor and Outdoor Injury Prevention/Safety. The program includes handouts, websites, and resources provided to parents of children in this age group. Parents will be instructed to review each topic over 10-weeks, approximately 1 topic every 1.5 weeks

Placebo Comparator: 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.
Behavioral: Active Control
The active control is an adaptation of a web-based application developed in our previous study (R01-HS024273). The program will include general information typically provided during well-child or NICU follow up visits. Six topic areas are: Immunizations, Common Childhood Illnesses, Nutrition, Dental Health, and Indoor and Outdoor Injury Prevention/Safety. The program includes handouts, websites, and resources provided to parents of children in this age group. Parents will be instructed to review each topic over 10-weeks, approximately 1 topic every 1.5 weeks




Primary Outcome Measures :
  1. Change in Parenting Self-efficacy and Competence (Parenting Sense of Competence Scale (PSOC)) [ Time Frame: 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.

  2. Change in observed parent-child interaction and emotional connection (Welch Emotional Connection Scale (WECS) [ Time Frame: 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).

  3. Change in Child Behavior (Eyberg Child Behavior Inventory (ECBI)) [ Time Frame: 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.

  4. Change in Parenting Behaviors (Parent Questionnaire (PQ)) [ Time Frame: 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.

  5. Change in Parenting Stress (Parenting Stress Index-Short Form (PSI-SF)) [ Time Frame: 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.

  6. Change in Child Behavior (Child Behavior Checklist 1½-5 (CBCL)) [ Time Frame: 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).

  7. Change in Parenting Style and Behavior (Parenting Style Dimensions Questionnaire) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Program satisfaction [ Time Frame: 3-month post baseline follow up ]
    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).

  2. Intervention engagement [ Time Frame: up to 3-months post-baseline (during intervention period) ]
    Metrics include: time stamps of all parent use of the program. Data is all accessible through digital tracking.

  3. Parent engagement - coaching calls [ Time Frame: up to 3-months post-baseline (during intervention period) ]
    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.


Other Outcome Measures:
  1. General Demographics and Income [ Time Frame: Baseline ]
    Demographics (e.g., age, race/ethnicity, household structure) will be collected using a 32-item demographic inventory.

  2. Neighborhood and community characteristics [ Time Frame: Baseline ]
    9 items from the National Survey of Children's Health. Questions include perceived neighborhood social support, condition, and safety

  3. Confusion, Hubbub, and Order Scale (CHAOS) [ Time Frame: Baseline ]
    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.

  4. Confusion, Hubbub, and Order Scale (CHAOS) [ Time Frame: 3-month post-baseline ]
    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.

  5. Confusion, Hubbub, and Order Scale (CHAOS) [ Time Frame: 6-month post-baseline ]
    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. Confusion, Hubbub, and Order Scale (CHAOS) [ Time Frame: 12-month post-baseline ]
    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.

  7. Vineland Adaptive Behavior Scale (3rd edition) [ Time Frame: Eligibility screening ]
    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)

  8. Perceived Stress Scale [ Time Frame: Baseline ]
    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.

  9. Perceived Stress Scale [ Time Frame: 3-month post-baseline ]
    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.

  10. Perceived Stress Scale [ Time Frame: 6-month post-baseline ]
    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.

  11. Perceived Stress Scale [ Time Frame: 12-month post-baseline ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05217615


Contacts
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Contact: Susie Breitenstein, PhD 614-688-4614 breitenstein.5@osu.edu
Contact: Sandra Solove, MA 614-247-8366 solove.3@osu.edu

Locations
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United States, Illinois
Rush University Children's Hospital Recruiting
Chicago, Illinois, United States, 60612
Contact: Kousiki Patra, MD    312-942-6640    kousiki_patra@rush.edu   
Principal Investigator: Kousiki Patra, MD         
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Amanda Miglin, BS    614-722-2777    amanda.miglin@nationwidechildrens.org   
Principal Investigator: Sarah Keim, PhD         
Ohio State University College of Nursing Recruiting
Columbus, Ohio, United States, 43210
Contact: Susie Breitenstein, PhD         
Sponsors and Collaborators
Ohio State University
Rush University Medical Center
Nationwide Children's Hospital
Klein Buendel, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Susie Breitenstein, Professor, Assistant Dean for Research and Innovation, Ohio State University
ClinicalTrials.gov Identifier: NCT05217615    
Other Study ID Numbers: 2020B0244
First Posted: February 1, 2022    Key Record Dates
Last Update Posted: February 3, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Problem Behavior
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Behavioral Symptoms