ParentingezParentNCT05217615
Parent Training for Parents of Toddlers Born Very Premature:
A study testing ezParent and Coaching calls in people with Parenting and Problem Behavior, run by Ohio State University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 months and older
- Conditions the study is for
- Parenting, Problem Behavior, Premature Birth
- What is being tested?
- ezParent and Coaching calls
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 452 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Aug 2022to 21 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Rush University Children's Hospital
Chicago, Illinois, 60612
Nationwide Children's Hospital
Columbus, Ohio, 43205
Ohio State University College of Nursing
Columbus, Ohio, 43210
About this study
Official 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:
- 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.
Read the 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:
- 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.
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.
- Conditions
- Parenting, Problem Behavior, Premature Birth, Parenting Intervention
- Being tested
- ezParent, Coaching calls, Active Control
- Medical subject headings
- Problem Behavior, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ezParentBehavioural
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.
Coaching callsBehavioural
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 ControlBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: baseline; 3-month, 6-month, 12-month post-baseline
Secondary outcomes (3)
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).
Measured: 3-month post baseline follow up
Intervention engagement
Metrics include: time stamps of all parent use of the program. Data is all accessible through digital tracking.
Measured: up to 3-months post-baseline (during intervention period)
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.
Measured: up to 3-months post-baseline (during intervention period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start3 Aug 2022
- Primary completion21 Jan 2026
- Study completion21 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 Factorial Design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Rush University Medical Center, Klein Buendel, Inc., Nationwide Children's Hospital
- Responsible party
- Principal investigator, Susie Breitenstein, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217615
- Sponsor's protocol ID
- 2020B0244
- Acronym
- ezParent
- Status last verified
- Apr 2026
- First submitted
- 3 Jan 2022
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Breitenstein SM, Greene MM, Miller G, Smoske S, Alqasem S, Harrington J, Filipkowski J, Moser MJ, Schoeny M. Integrating coaching into digital behavioral interventions: a scalable training model and fidelity evaluation. Ann Behav Med. 2026 Jan 7;60(1):kaag014. doi: 10.1093/abm/kaag014.
PubMed 42847362Greene 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.
PubMed 35732380
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Training for Parents of Toddlers Born Very Premature: A Factorial Design to Test Web Delivery and Telephone Coaching
- ClinicalTrials.gov ID
- NCT05217615
- Acronym / sponsor ID
- ezParent / 2020B0244
- Conditions
- Parenting, Problem Behavior, Premature Birth, Parenting Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Rush University Medical Center, Klein Buendel, Inc., Nationwide Children's Hospital
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 21 Jan 2026 (actual)
- Study completion
- 21 Jan 2026 (actual)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 2x2 Factorial Design
| Arm | Type | Receives |
|---|---|---|
| ezParent+ coach | Experimental | Behavioral: ezParent, Behavioral: Coaching callsezParent - 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. |
| ezParent | Experimental | Behavioral: ezParentezParent - 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. |
| Active Control+coach | Active comparator | Behavioral: Coaching calls, Behavioral: Active ControlActive 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. |
| Active Control | Placebo comparator | Behavioral: Active ControlThe 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. |
Who may qualify
- Ages
- 20 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ezParentThe 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. | Behavioural | ezParent, ezParent+ coach |
| Coaching callsThe 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. | Behavioural | Active Control+coach, ezParent+ coach |
| Active ControlThe 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 | Behavioural | Active Control, Active Control+coach |
Primary outcome
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.
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).
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.
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.
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.
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).
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.
3 secondary outcomes
Program satisfaction
Time frame: 3-month post baseline follow up
Intervention engagement
Time frame: up to 3-months post-baseline (during intervention period)
Parent engagement - coaching calls
Time frame: up to 3-months post-baseline (during intervention period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Derived from this study: PubMed 42847362Breitenstein SM, Greene MM, Miller G, Smoske S, Alqasem S, Harrington J, Filipkowski J, Moser MJ, Schoeny M. Integrating coaching into digital behavioral interventions: a scalable training model and fidelity evaluation. Ann Behav Med. 2026 Jan 7;60(1):kaag014. doi: 10.1093/abm/kaag014.
- Derived from this study: PubMed 35732380Greene 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ezParent and Coaching calls in people with Parenting and Problem Behavior, run by Ohio State University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05217615, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.