Parent Training for Parents of Toddlers Born Very Premature:

NCT05217615 | Completed DMC

• 1 other identifier: 2020B0244
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 3

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. 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. 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. 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.

Conditions

Parenting; Problem Behavior; Premature Birth; Parenting Intervention

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• 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)

Other Outcomes (11)

• General Demographics and Income

  Baseline

• Neighborhood and community characteristics

  Baseline

• Confusion, Hubbub, and Order Scale (CHAOS)

  Baseline

Study Arms (4)

ezParent+ coach

EXPERIMENTAL

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; Behavioral: Coaching calls

ezParent

EXPERIMENTAL

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

Active Control+coach

ACTIVE 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. 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; Behavioral: Active Control

Active Control

PLACEBO COMPARATOR

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

Interventions

ezParent BEHAVIORAL

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.

ezParent; ezParent+ coach

Coaching calls BEHAVIORAL

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.

Active Control+coach; ezParent+ coach

Active Control BEHAVIORAL

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

Active Control; Active Control+coach

Eligibility Criteria

• Age: 20 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Ohio State University: lead
• Rush University Medical Center: collaborator
• Klein Buendel, Inc.: collaborator
• Nationwide Children's Hospital: collaborator

Study Sites (3)

Rush University Children's Hospital

Chicago, Illinois, 60612, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Ohio State University College of Nursing

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Greene MM, Schoeny ME, Berteletti J, Keim SA, Neel ML, Patra K, Smoske S, Breitenstein S. ezPreemie study protocol: a randomised controlled factorial trial testing web-based parent training and coaching with parents of children born very preterm. BMJ Open. 2022 Jun 22;12(6):e063706. doi: 10.1136/bmjopen-2022-063706.

  PMID: 35732380 DERIVED

MeSH Terms

Conditions

Problem Behavior; Premature Birth

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Associate Dean for Research

Model Details: 2x2 Factorial Design

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: February 1, 2022
• Study Start: August 3, 2022
• Primary Completion: January 21, 2026
• Study Completion: January 21, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)