Parent Training for Premature Birth Outcomes

(ezParent Trial)

Not currently recruiting at 2 trial locations

Overseen By Susie Breitenstein, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Profound developmental impairment

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a digital program called ezParent, along with weekly coaching calls, can assist parents of children born very preterm (before 32 weeks of pregnancy). The study will examine the effects of these tools on parenting skills and child behavior over time. Eligible participants include English-speaking parents with a child aged 20-30 months born very preterm and who have internet access. The trial will compare different combinations of the ezParent program and coaching calls to assess their impact on family outcomes. As an unphased trial, this study provides a unique opportunity for parents to contribute to innovative research that could enhance family well-being.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on a web-based parent training program and coaching, so it's unlikely that medication changes are required.

What prior data suggests that the ezParent program and coaching calls are safe for parents and children?

Research shows that the ezParent program is an online tool designed to help parents improve their parenting skills. Based on the Chicago Parent Program, which has a proven track record, studies have not found any major safety concerns with ezParent, suggesting participants generally find it safe to use.

When combined with coaching calls, ezParent aims to offer extra support and clear guidance. These coaching calls are brief, lasting about 15 minutes each week. Previous research tested this approach and found no safety issues. The combination of online sessions and phone support enhances learning without creating risk.

Overall, both the ezParent program and the coaching calls are considered safe according to available research. This makes participating in these activities a low-risk option for parents who want to improve their skills and support their children's development. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ezParent program because it offers a unique, digital approach to improving parenting skills for parents of premature infants. Unlike traditional in-person parenting programs, ezParent is an accessible digital tool that parents can use at their convenience. It focuses on promoting positive parenting behaviors, such as rewarding positive actions and minimizing attention to negative ones, to improve child behavior outcomes. Additionally, the inclusion of brief weekly coaching calls provides personalized support and motivation, enhancing the program's impact. This combination of digital convenience and personalized coaching sets ezParent apart from other parenting resources, aiming to make a significant difference in outcomes for premature infants and their families.

What evidence suggests that this trial's treatments could be effective for improving parent and child outcomes after premature birth?

Research shows that the ezParent program, a digital version of the Chicago Parent Program, encourages positive parenting. Studies have found that parents using ezParent feel more confident and use less harsh discipline. While one study didn't find significant changes in parent or child behavior, another showed high engagement, with parents completing most of the program. In this trial, some participants will receive the version of ezParent that includes coaching calls. Evidence suggests these calls increase parent involvement and aid learning. Overall, combining ezParent with coaching may enhance the program's effectiveness, leading to better outcomes for both parents and children. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for English-speaking parents or guardians of very preterm toddlers (born before 32 weeks gestation) aged between 20-30 months, who have access to a smartphone, tablet, or computer with Wi-Fi. Children with profound developmental impairments as measured by the Vineland Scale are not eligible.

Inclusion Criteria

I am a parent and I speak English.

Parent has a smartphone, tablet, or computer with Wi-Fi or wireless access to receive the digital intervention component for their assigned group.

I am the parent or guardian of a child born very preterm, now aged 20-30 months.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Parents participate in a 10-week intervention period involving the ezParent program and/or coaching calls

10 weeks

Weekly coaching calls for those in coaching groups

Follow-up

Participants are monitored for changes in parenting and child behavior outcomes

12 months

Surveys and observations at 3, 6, and 12 months post-baseline

What Are the Treatments Tested in This Trial?

Interventions

• Active Control
• Coaching calls
• ezParent

Trial Overview The study tests a web-based parent training program called ezParent and telephone coaching calls on improving parenting skills and child behavior. Parents will be randomly assigned to one of four groups: ezParent with coach, just ezParent, Active Control with coach, or just Active Control.

How Is the Trial Designed?

Group I: ezParent+ coach Experimental Treatment 2 Interventions

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.

Group II: ezParent Experimental Treatment 1 Intervention

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.

Group III: Active Control+coach Active Control 2 Interventions

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.

Group IV: Active Control Placebo Group 1 Intervention

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.

ezParent is already approved in United States for the following indications:

Approved in United States as ezParent for:

• Parenting skills improvement
• Child behavior problems prevention

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Nationwide Children s Hospital in Columbus, Ohio

Collaborator

Trials

3

Recruited

2,500+

Rush University Medical Center

Collaborator

Trials

448

Recruited

247,000+

Nationwide Children's Hospital

Collaborator

Trials

354

Recruited

5,228,000+

Klein Buendel, Inc.

Industry Sponsor

Trials

41

Recruited

20,000+

Published Research Related to This Trial

Participation in parent groups for parents of extremely premature newborns during hospitalization was beneficial, with most parents reporting positive outcomes from their involvement.

The study, which included 44 parents of extremely premature infants, suggests that establishing such support groups is an important psychological intervention in neonatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Parent groups. Crisis intervention for parents of extremely premature infants during hospitalization]. Sylvest, A., Peitersen, B.[2015]

A study involving 160 low-income parents showed that most had good access to the internet and were comfortable using it, indicating a strong potential for internet-based parent training programs.

In a pilot study with 89 parents, while there was high initial interest in an online parenting program, only 9% reported frequent use, highlighting the need for strategies to encourage deeper engagement with the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Internet-based Parent Training for Low-income Parents of Young Children. McGoron, L., Hvizdos, E., Bocknek, EL., et al.[2019]

The ezParent program, a tablet-based adaptation of a parent training program, was used by 59 parents of young children in low-income areas, revealing that those who completed more modules experienced greater benefits from the program.

Parents who faced barriers to completing the modules were less likely to report benefits, indicating that understanding user experiences can help improve the design and effectiveness of digital parenting interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Income Parents' Perceptions of and Engagement With a Digital Behavioral Parent Training Program: A Mixed-Methods Study. Brager, J., Breitenstein, SM., Miller, H., et al.[2021]

The ezParent program, a tablet-based adaptation of the Chicago Parent Program, achieved an impressive module completion rate of 85.4%, significantly higher than the 50.6% attendance rate of the traditional face-to-face program, indicating it is a more accessible option for busy parents.

Parents using the ezParent program reported high satisfaction, with 88% finding it very helpful, and showed significant improvements in parenting warmth, suggesting that this digital approach can effectively enhance parenting skills in low-income, ethnic minority families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent Use and Efficacy of a Self-Administered, Tablet-Based Parent Training Intervention: A Randomized Controlled Trial. Breitenstein, SM., Fogg, L., Ocampo, EV., et al.[2018]

An individualized psychosocial parental support (PPS) program for parents of extremely low-birth-weight (ELBW) infants was associated with a significant reduction in the length of hospital stay (LOS), with the PPS group averaging 86 days compared to 99 days for the control group.

The study involved 41 ELBW infants, and while the PPS program showed benefits in reducing LOS, no other significant differences in short-term neonatal outcomes were observed, indicating the need for further research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial parental support programs and short-term clinical outcomes in extremely low-birth-weight infants. Nearing, GB., Salas, AA., Granado-Villar, D., et al.[2011]

The study will evaluate the implementation and efficacy of the ezParent program, a tablet-based behavioral parent training intervention, in four pediatric primary care sites with 312 parents of children aged 2 to 5 years.

This innovative approach aims to increase parent participation in training programs, potentially improving child behavior outcomes and parent-child relationships while being cost-effective and accessible through existing healthcare infrastructure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study protocol testing the implementation, efficacy, and cost effectiveness of the ezParent program in pediatric primary care. Breitenstein, SM., Schoeny, M., Risser, H., et al.[2018]

This review aims to evaluate the effectiveness of eHealth educational interventions on parental outcomes, such as mental health and involvement in infant pain management, as well as infant outcomes related to pain and health.

The study will include various experimental designs and focus on parents from pregnancy to one year postpartum, assessing how well these interventions improve knowledge and reduce stress related to managing their infant's pain during medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of parent-targeted eHealth educational interventions on infant procedural pain management: a systematic review protocol. Richardson, B., Benoit, B., Rutledge, K., et al.[2023]

The ezParent program, combined with weekly coaching calls, was well-accepted by parents of very low birth weight infants, with high completion rates of 85% for the program modules and 89% for coaching calls over a 10-week period.

Parents reported improvements in their self-efficacy and observed reductions in their child's externalizing behaviors, indicating that the program may effectively support parenting practices for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation and Acceptability of a Digitally Delivered Intervention for Parents of Very Low Birth Weight Infants. Greene, MM., Patra, K., Czyzewski, P., et al.[2021]

The Infant Health and Development Program, which targeted low birth weight and premature infants, showed small but significant improvements in mother-child interactions at 30 months, with mothers providing better assistance and children displaying more enthusiasm and competence.

Factors such as maternal ethnicity and education significantly influenced the quality of interactions, highlighting the importance of considering these variables in early intervention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing maternal interactive behavior and child social competence in low birth weight, premature infants. Spiker, D., Ferguson, J., Brooks-Gunn, J.[2021]

Citations

1. trialx.com trialx.com/clinical-trials/listings/275224/parent-training-for-parents-of-toddlers-born-very-premature/

Parent Training for Parents of Toddlers Born Very Premature The purpose of the study is to test the effects of the ezParent (web-based parent training program) intervention and telephone coaching calls ( ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9226920/

a randomised controlled factorial trial testing web-based ... The purpose of this study is to test the effects of ezParent and coaching calls on outcomes of parents and children born VPT after 3, 6 and 12 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022347620314980

A Randomized Trial of Digitally Delivered, Self ... Our findings suggest that ezParent as a fully self-administered digital intervention did not improve parent or child behavior in this population of parents.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3442153/

The Chicago Parent Program: Comparing 1-Year Outcomes ... Compared to controls, intervention parents had improved self-efficacy, used less corporal punishment and more consistent discipline, and ...

5. europepmc.org europepmc.org/article/med/32496399

Adaptation and Acceptability of a Digitally Delivered ... The study evaluated the ezParent program with coaching calls for parents of VLBW infants. Parents completed 85% of modules and 89% of calls, with modest ...

6. withpower.com withpower.com/trial/phase-problem-behavior-4-2022-3c4b0

Parent Training for Premature Birth Outcomes (ezParent Trial) Is the ezParent program safe for use in humans? The available research on the ezParent program, a digital parent training intervention, does not report any ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11255911/

Parent-Guided Developmental Intervention for Infants With ... Parent-guided early intervention can improve neurodevelopmental outcome of very preterm or very low birth weight infants born in LMICs.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0885200624001364

Family Check-Up Online effects on parenting and ... The current study evaluates the efficacy of a mobile app-based parenting support program, the Family Check-Up Online (FCU-O) with telehealth coaching support, ...