Parent Training for Premature Birth Outcomes

(ezParent Trial)

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

490 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that Parent Training for Premature Birth Outcomes is an effective treatment?

The available research shows that the Parent Training for Premature Birth Outcomes, specifically the ezParent program with coaching calls, is well-received by parents of very low birth weight infants, suggesting its acceptability. Additionally, a study on a similar intervention, the Infant Health and Development Program, found positive effects on mother-child interactions and child social competence. This indicates that such programs can improve parent-child relationships and child behavior. Furthermore, parent groups for extremely premature infants were found to be beneficial for parents during their child's hospitalization, highlighting the importance of psychological support. These findings collectively support the effectiveness of Parent Training for Premature Birth Outcomes. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Parent Training for Premature Birth Outcomes?

Research shows that digital parent training programs like ezParent, combined with coaching calls, are well-received by parents of very low birth weight infants, suggesting they may help improve behavioral outcomes. Additionally, early intervention programs for low birth weight infants have shown positive effects on mother-child interactions and child social competence. ^{1 2 3 4 5}

What safety data exists for the Parent Training for Premature Birth Outcomes treatment?

The available research primarily focuses on the feasibility, engagement, and efficacy of the ezParent program, a digital adaptation of the Chicago Parent Program. While these studies highlight the program's potential benefits and barriers, they do not specifically address safety data. The studies emphasize the program's accessibility and usability among low-income parents, but there is no direct mention of safety concerns or adverse effects related to the treatment. ^{2 6 7 8 9}

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 safety concerns for its use in humans. The studies focus on its feasibility, accessibility, and engagement, particularly among low-income parents, without mentioning any adverse effects. ^{2 6 7 8 9}

Is the treatment ezParent a promising treatment for premature birth outcomes?

Yes, the ezParent program is a promising treatment. It is a digital parent training program that helps improve parenting skills and child behavior, especially for low-income families. It is convenient and accessible, as it can be used on tablets, making it easier for parents to participate. Studies show that parents who use more of the program report more benefits, and it is designed to be effective and acceptable for families in need. ^{1 6 7 8 9}

How is the ezParent treatment unique for premature birth outcomes?

The ezParent treatment is unique because it is a tablet-based, self-administered parent training program designed to be more accessible and convenient for parents, especially those in low-income settings, compared to traditional face-to-face sessions. It adapts the Chicago Parent Program to a digital format, making it easier to deliver in primary care settings and includes features like weekly coaching calls for parents of very low birth weight infants. ^{1 6 7 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Adaptation and Acceptability of a Digitally Delivered Intervention for Parents of Very Low Birth Weight Infants. [2021]

2. Australia pubmed.ncbi.nlm.nih.gov

The impact of parent-targeted eHealth educational interventions on infant procedural pain management: a systematic review protocol. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Enhancing maternal interactive behavior and child social competence in low birth weight, premature infants. [2021]

4. Denmark pubmed.ncbi.nlm.nih.gov

[Parent groups. Crisis intervention for parents of extremely premature infants during hospitalization]. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Psychosocial parental support programs and short-term clinical outcomes in extremely low-birth-weight infants. [2011]

6. Canada pubmed.ncbi.nlm.nih.gov

Parent Use and Efficacy of a Self-Administered, Tablet-Based Parent Training Intervention: A Randomized Controlled Trial. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Feasibility of Internet-based Parent Training for Low-income Parents of Young Children. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Low-Income Parents' Perceptions of and Engagement With a Digital Behavioral Parent Training Program: A Mixed-Methods Study. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

A study protocol testing the implementation, efficacy, and cost effectiveness of the ezParent program in pediatric primary care. [2018]