Parent Coaching for Children on Ventilators

Overseen By Sarah Sobotka, MD, MSCP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Wards of the state

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new support system for parents of children who rely on ventilators to breathe. The study aims to determine if parent-to-parent coaching from experienced parents can help new parents manage home healthcare for their children. It is designed for parents in Illinois whose children are about to leave the hospital with a tracheostomy and a ventilator. Parents near the University of Chicago may find this trial a suitable opportunity. As an unphased trial, it offers a unique chance to contribute to innovative support systems and improve care for similar families.

Do I have to stop taking my current medications to join the trial?

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

What prior data suggests that this parent-to-parent coaching model is safe for children on ventilators?

Research has shown that parent-to-parent coaching can be a helpful and safe method for families with children on ventilators. One study found that parents felt more emotionally supported after joining these programs, with satisfaction scores rising from 81.7 to 87.0. This indicates that the coaching is well-received and not harmful.

Other studies emphasize the importance of educating and training parents. These programs often include practice with emergency situations, such as ventilator problems. Parents report feeling more prepared after this training.

Overall, evidence suggests that parent-to-parent coaching is safe and beneficial. Participants find the coaching supportive and empowering, with no reports of negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about parent-to-parent coaching for families of children on ventilators because it offers a unique, supportive approach that current medical treatments don't provide. Unlike traditional medical interventions that focus on the child’s physical health, this method empowers parents by building their confidence and skills through shared experiences and practical advice. This coaching emphasizes real-world strategies for managing home healthcare, fostering a sense of community and resilience among parents who often face overwhelming challenges. By equipping parents with these tools and insights, the treatment aims to improve the overall care environment and quality of life for both the child and the family.

What evidence suggests that parent-to-parent coaching is effective for children on ventilators?

This trial will evaluate the effectiveness of parent-to-parent coaching for families with children who need ventilators. Research has shown that coaching from one parent to another can be beneficial. Specifically, studies found that parents felt better supported emotionally, with satisfaction scores rising from 81.7 to 87.0. Additionally, fewer security calls for upset parents suggest that the coaching reduces stress. This method aims to empower parents by sharing practical tips and support from those with similar experiences, creating a supportive community that makes caring for their child at home feel less overwhelming. ^{1 2 6 7 8}

Who Is on the Research Team?

Sarah Sobotka, MD, MSCP

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for parents in Illinois with children who have a tracheostomy and ventilator, awaiting hospital discharge. Parents should live within an hour of the University of Chicago and be enrolling their child in the DSCC Home Care Program. They must have legal custody and plan to reside with the child.

Inclusion Criteria

Parents of children with a tracheostomy and ventilator awaiting hospital discharge in Illinois

Parents must live or have their child hospitalized within approximately a 1 hour radius of the University of Chicago

The child must be enrolled in, or in the process of enrolling in the Division of Specialized Care for Children (DSCC) Home Care Program

Exclusion Criteria

Wards of the state

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Parent Coaching

Parent-to-parent coaching model with experienced family members of children with IMV as parent coaches. Includes introductions, rapport building, and a series of coaching points.

6 months

Meetings as needed (text, video, phone, in-person)

Follow-up

Participants are monitored for changes in empowerment and nursing coverage, and satisfaction with the coaching program.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Parent-to-parent coaching

Trial Overview The study tests a parent-to-parent coaching model where experienced family members guide those new to caring for children on invasive mechanical ventilation (IMV), aiming to empower them before hospital discharge.

How Is the Trial Designed?

Group I: Parent Coaching Experimental Treatment 1 Intervention

Participants will be involved for about 6 months or until they feel that they no longer need the parent-to-parent support. Parents will participate in the following contact attempts: * Introductions and rapport building which will include a demographic survey with a needs assessment, and the Family Empowerment Scale (FES) * A series of coaching points which may include some or all of the following topics * Interviewing and selecting a home health agency * Expectation setting for home based nursing care * Tips for finding home health professionals from inpatient nursing * Tips for using personal and professional care networks to find and recruit home health team members * An exit interview assessment including the FES and components of the demographic survey that may have changed

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

The study highlights the significant impact of having a ventilator-dependent child on family dynamics, revealing that parents face various barriers and require resources to manage their child's care effectively.

Parents emphasized the importance of normalizing their child's experiences and being assertive in interactions with healthcare professionals, indicating a need for external support systems beyond the family.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing chronic illness: parents with a ventilator--dependent child. Scharer, K., Dixon, DM.[2006]

A qualitative study involving 35 ventilator-dependent children and their parents revealed that mechanical ventilation improved the children's health and quality of life, as they felt better with sufficient breath, although the exact benefits were hard to measure, especially for preverbal children.

The study highlighted the need for redefined healthcare services that focus on children's perspectives of quality of life, as many experienced negative social impacts and low self-esteem, indicating that current home healthcare services may not adequately address their social needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health and quality of life of ventilator-dependent children. Noyes, J.[2016]

A structured parent-to-parent support program can effectively help parents cope with the stress of having a baby in the neonatal intensive care unit (NICU) by providing essential resources and emotional support.

Successful implementation of such a program requires commitment from hospital staff, recruitment and training of volunteer parents, and continuous collaboration between parents and professionals to ensure the program's sustainability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent partners: a parent-to-parent support program in the NICU. Part II: Program implementation. Jarrett, MH.[2004]

A parent-to-parent support program at Butterworth Hospital, involving 110 trained volunteer parents, significantly improved maternal mood, maternal-infant relationships, and home environments for over 900 families with high-risk infants in the NICU.

The program effectively addresses the emotional and informational needs of parents during a crisis, demonstrating that support from experienced parents can be invaluable in helping new NICU families cope with their challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creative caring in the NICU: parent-to-parent support. Lindsay, JK., Roman, L., DeWys, M., et al.[2013]

A study involving 486 parents of children admitted to a PICU found that 94% consented to receive follow-up questionnaires 12 months later, highlighting strong parental willingness to participate in follow-up research.

The method of questionnaire completion significantly affected response rates, with online submissions having the highest completion rate (77%), indicating that accommodating parental preferences can enhance participation in follow-up studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Methods to Collect Follow-Up Information From Parents 12 Months After Their Child's Emergency Admission to Pediatric Intensive Care. Pulham, RA., Wray, J., Feinstein, Y., et al.[2020]

A study involving 22 parents of critically injured children revealed that two years post-injury, parents face significant emotional challenges and require ongoing psychosocial support to aid their recovery.

The research highlights the need for a dedicated trauma family support role to provide continuous care and targeted interventions, which can help families adapt and prevent long-term negative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent perspectives and psychosocial needs 2 years following child critical injury: A qualitative inquiry. Foster, K., Van, C., McCloughen, A., et al.[2021]

In a study involving 272 parents of critically ill children on ECMO, over 60% felt pressured to consent to the treatment due to their child's severe condition, highlighting the emotional burden parents face during such critical decisions.

Parents reported that communication with healthcare providers and observing their child's progress helped alleviate anxiety, emphasizing the importance of supportive care and follow-up contact after the experience, especially for those who faced the loss of their child.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental experience of highly technical therapy: survivors and nonsurvivors of extracorporeal membrane oxygenation support. Curley, MA., Meyer, EC.[2015]

Parents of ventilator-dependent children transitioning from hospital to home experience significant emotional and practical burdens, including feelings of isolation and the challenge of maintaining a sense of normalcy.

Families can provide competent care at home when adequately supported, highlighting the need for better education and resources for healthcare professionals to assist these families during the discharge process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parents' perceptions of the transition of their child who is ventilator dependent from hospital to home. Condon, A.[2023]

The implementation of a standardized family stress screening tool in a pediatric intensive care unit (PICU) led to a significant increase in stress screenings from 0% to 100% over 18 months, ensuring that all families received timely support.

Parent satisfaction regarding emotional support improved significantly, with scores rising from 81.7 to 87.0, and the number of security calls for distressed families decreased by 50%, indicating a reduction in family crises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Co-designed PICU Family Stress Screening and Response System to Improve Experience, Quality, and Safety. Liaw, KR., Cho, J., Devins, L., et al.[2023]

A navigator-based parent support intervention (PICU Supports) was positively received by parents, with 91.1% finding it helpful, but it did not significantly improve satisfaction scores compared to a standard informational brochure.

In a study involving 382 families, the percentage of 'excellent' responses regarding decision-making satisfaction was slightly higher for the PICU Supports group (60.4%) than for the brochure group (56.1%), but this difference was not statistically significant, indicating the need for further research with larger sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Comparative Trial to Evaluate a PICU Navigator-Based Parent Support Intervention. Michelson, KN., Frader, J., Charleston, E., et al.[2022]

Empowering parents in pediatric intensive care can significantly enhance the quality of care by incorporating their satisfaction and experiences into quality improvement initiatives.

A framework that focuses on family-centered care and parental needs can lead to effective quality improvement projects, ultimately benefiting both parents and healthcare teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent satisfaction in the pediatric ICU. Latour, JM., van Goudoever, JB., Hazelzet, JA.[2008]

Children who survive critical illness in pediatric intensive care units (PICUs) often face long-term health challenges known as post-intensive care syndrome-pediatrics (PICS-p), which can impact their development for years.

There is a growing recognition in the PICU community of the need to assess long-term outcomes for these children, and efforts are being made to establish standardized follow-up care and research programs to better support families and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transitions from short to long-term outcomes in pediatric critical care: considerations for clinical practice. Long, DA., Fink, EL.[2022]

Out of 407 articles on pediatric critical illness outcomes, 161 (40%) specifically measured overall health, with a focus on populations like traumatic brain injury and general PICU patients, indicating a significant interest in understanding health post-illness.

A total of 39 different measures were used to assess overall health, with the Glasgow Outcome Scale and Pediatric Overall Performance Category being the most prevalent, highlighting the need for standardized evaluation methods to improve care and recovery for critically ill children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overall Health Following Pediatric Critical Illness: A Scoping Review of Instruments and Methodology. Carlton, EF., Pinto, N., Smith, M., et al.[2023]

Citations

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Parent education programs for children assisted by ... In this program, simulated emergency scenarios for parents of children assisted by IMV included decannulation, ventilator malfunction, respiratory distress, ...

2. withpower.com withpower.com/trial/parent-coaching-for-children-on-ventilators-b10c0

Parent Coaching for Children on Ventilators Parent satisfaction regarding emotional support improved significantly, with scores rising from 81.7 to 87.0, and the number of security calls for distressed ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0882596322001543

Parent education programs for children assisted by ... The aim of this review is to identify existing literature about parent education programs, synthesize the evidence, and identify gaps in the literature for ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772628223000535

Supporting decisions about pediatric home ventilation Parents and clinicians of children facing home ventilation decisions were enrolled at 3 centers using a pre/post cohort design.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37348312/

Family-Reflections.com: Creating a parent-to ... This novel parent-to-parent tool shows promise for expanding access to balanced, family-centered information about pediatric home ventilation.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0882596324002641

Parent perspectives on education to support hospital ... Parent caregivers of children with invasive mechanical ventilation undergo extensive hospital-based education. •. Many parents report training prepared them to ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39025713/

Parent perspectives on education to support hospital ... Parent perspectives on education to support hospital discharge for children with invasive mechanical ventilation.

8. researchgate.net researchgate.net/publication/371630144_Family-Reflectionscom_Creating_a_Parent-to-Parent_Web-Based_Tool_Regarding_Pediatric_Home_Ventilation

Creating a Parent-to-Parent Web-Based Tool Regarding ... Results: We created 6 composite character families to communicate 6 themes about home ventilation: 1) Considering treatment options, 2) Talking ...