Clinical trial NCT05217615: Parent Training for Parents of Toddlers Born Very Premature:
Official title: Parent Training for Parents of Toddlers Born Very Premature: A Factorial Design to Test Web Delivery and Telephone Coaching
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parenting
Problem Behavior
Premature Birth
Parenting Intervention
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Rush University Medical Center
name: Klein Buendel, Inc.
name: Nationwide Children's Hospital
First posted: 2022-02-01
Enrollment: 490
Sex: ALL
Minimum age (years): 20
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2 Factorial Design
Primary purpose: PREVENTION

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.

Detailed description: 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:

1. 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.
2. 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.
3. Parents in the ezParent and ezParent+coach groups will report greater reductions in child behavior problems vs. active control.
4. 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.
5. 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.

After consent and completion of baseline surveys, parent-child dyads are randomized to one of four groups: ezParent, ezParent+coach, control, or control+coach. Based on participants' random group assignments, parents will receive instructions on the use of the assigned digital intervention and if parents are in a coaching group will schedule their first coaching call. The intervention period is 10-weeks. Parents in all groups will complete their digital program during that 10-weeks and parents in coaching groups will participate in weekly, brief (\~15 minutes) coaching calls. Intervention activities are for parents only. There is no active child involvement during the intervention period. However, children may experience changes in parent behavior based on their receipt of the intervention content.

The ezParent Program is a 6-module digital adaptation of the group-based Chicago Parent Program (CPP). The CPP is an evidence-based, 12-session program for parents of young children. The purpose of the program is to strengthen parenting, decrease child d behavior problems, and increase child prosocial behavior. Each module includes: a video narrator describing parenting strategies; video vignettes of parents and children as examples of how parenting strategies work; questions following each vignette for parents to reflect upon; interactive activities for parents to complete; knowledge questions to assess parent understanding of the strategies; and practice assignments. The control program includes 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 in the coaching groups will receive brief (\~15 min) weekly telephone coaching calls to provide parents with an opportunity to receive clarification of intervention content (e.g., ezParent or control), encouragement and reinforcement of intervention completion, and support tailoring of intervention content for their child.

Parents will complete surveys and observations at 3-month post-baseline and surveys at 6 months and 12 months post-baseline.

Eligibility 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.

Primary outcomes:
measure: Change in Parenting Self-efficacy and Competence (Parenting Sense of Competence Scale (PSOC))
timeFrame: baseline; 3-month, 6-month, 12-month post-baseline
measure: Change in observed parent-child interaction and emotional connection (Welch Emotional Connection Scale (WECS)
timeFrame: 3-month post baseline
measure: Change in Child Behavior (Eyberg Child Behavior Inventory (ECBI))
timeFrame: baseline; 3-month, 6-month, 12-month post-baseline
measure: Change in Parenting Behaviors (Parent Questionnaire (PQ))
timeFrame: baseline; 3-month, 6-month, 12-month post-baseline
measure: Change in Parenting Stress (Parenting Stress Index-Short Form (PSI-SF))
timeFrame: baseline; 3-month, 6-month, 12-month post-baseline
measure: Change in Child Behavior (Child Behavior Checklist 1½-5 (CBCL))
timeFrame: baseline; 3-month, 6-month, 12-month post-baseline
measure: Change in Parenting Style and Behavior (Parenting Style Dimensions Questionnaire)
timeFrame: baseline; 3-month, 6-month, 12-month post-baseline
Secondary outcomes:
measure: Program satisfaction
timeFrame: 3-month post baseline follow up
measure: Intervention engagement
timeFrame: up to 3-months post-baseline (during intervention period)
measure: Parent engagement - coaching calls
timeFrame: up to 3-months post-baseline (during intervention period)
Other outcomes:
measure: General Demographics and Income
timeFrame: Baseline
measure: Neighborhood and community characteristics
timeFrame: Baseline
measure: Confusion, Hubbub, and Order Scale (CHAOS)
timeFrame: Baseline
measure: Confusion, Hubbub, and Order Scale (CHAOS)
timeFrame: 3-month post-baseline
measure: Confusion, Hubbub, and Order Scale (CHAOS)
timeFrame: 6-month post-baseline
measure: Confusion, Hubbub, and Order Scale (CHAOS)
timeFrame: 12-month post-baseline
measure: Vineland Adaptive Behavior Scale (3rd edition)
timeFrame: Eligibility screening
measure: Perceived Stress Scale
timeFrame: Baseline
measure: Perceived Stress Scale
timeFrame: 3-month post-baseline
measure: Perceived Stress Scale
timeFrame: 6-month post-baseline
measure: Perceived Stress Scale
timeFrame: 12-month post-baseline
Locations:
city: Chicago
country: United States
facility: Rush University Children's Hospital
state: Illinois
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohio State University College of Nursing
state: Ohio
Study officials:
References:
citation: 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.