Recruiting

Observational Study

Sponsor:

Nationwide Children's Hospital

Code:

NCT06769334

Conditions

Childhood Cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

PLAY Program

Study Details

Brief summary:

The goal of this clinical trial is to test and improve an online program for caregivers of young childhood cancer survivors called the Preparing for Life and Academics for Young Survivors program (PLAY). The PLAY program was created with a group of caregivers of young children with cancer and healthcare providers. Ultimately, investigators hope to see if the program can improve positive parenting behaviors, reduce caregiver stress, and help get young children ready for school. In the preliminary phase of this clinical trial, investigators are aiming to answer these questions:

1. Are caregivers of childhood cancer survivors willing to participate in the PLAY program and complete assessments before and after the program?
2. Do caregivers of childhood cancer survivors rate the PLAY program as easy to use?
3. Are caregivers of childhood cancer survivors satisfied with the PLAY program?
4. How can the PLAY program be improved in the future?
5. Does PLAY help improve how caregivers interact and read with their children or how they manage their own stress?

When the child is transitioning to maintenance phase therapies or is no longer actively in cancer treatment, caregivers will be invited to participate. If they agree to participate, they will complete surveys when they begin the study as well as a videotaped interaction task reading and playing with their child. Children will complete brief developmental testing at the beginning of the program.

Caregivers will then complete the PLAY Program, which will involve completing 7 weekly or bi-weekly online modules and meeting with a trained coach by videoconference for up to 10 one-hour sessions over three months. Sessions will focus on helping their child get ready for school and helping their family adjust and cope with stress.

Caregivers will repeat the surveys and videotaped interaction task again three months later, after the PLAY program is completed. They will also be invited to participate in an interview to learn about their experience in the program.

This study will happen over two phases. Participants in Phase I of this study will complete all parts of the study as described above. Participants in Phase II (beginning in winter 2025) will complete all parts of the study as described above and a six month follow up that will involve repeating the similar questionnaires and an additional videotaped interaction with their child. Teachers of children will also take part in Phase II with questionnaires at baseline and 3-months later, after participants have completed the PLAY program.

Conditions

Childhood Cancer

Study ID

NCT06769334

Start date

Dec 12, 2024

Status verified date

Nov, 2025

Completion date

Jan 30, 2027

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

For the caregiver:

  • Caregiver is the legal guardian of the child (e.g., mothers, fathers, grandparents, adoptive parents)
  • Caregiver lives with the child more than 50% of the time
  • Caregiver primary language is English
  • Caregiver lives within 150 miles of Nationwide Children's Hospital

For the childhood cancer survivor:

  • Received treatment for their cancer (e.g., chemotherapy, surgical resection, radiation therapy)
  • Completed cancer treatment or on maintenance therapy only, without evidence of recurrent disease
  • Childhood cancer survivor is currently between the ages of 3 years old to 6 years old, but no older than 6.5 years old at study enrollment

Exclusion Criteria for the childhood cancer survivor:

  • Has a documented neurodevelopmental disorder prior to their cancer diagnosis (e.g., neurofibromatosis, tuberous sclerosis, Down's syndrome, autism)
  • Did not receive any treatment for their cancer (e.g., chemotherapy, surgical resection, radiation)
  • Treated for a benign tumor

For the teacher:

Classroom or daycare teacher of the childhood cancer survivor

Study Design

Enrollment

105 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Preparing for Life and Academics for Young (PLAY) survivors program

PLAY is a digital health intervention involving 7 self-directed web-modules and up to 10 virtual coaching sessions conducted weekly to biweekly (7 paired plus up to 3 booster sessions) for caregivers of young childhood cancer survivors (3-6 years). The module content focuses on psychoeducation and positive parenting skills and the coaching focuses on live practice of positive parenting skills.

Interventions

PLAY Program

The PLAY Program is a web-based program created for caregivers of childhood cancer survivors. The program consists of seven modules with the following topics: 1) Introduction to the program 2) Self-Care 3) Relationships 4) Getting Ready for School 5) Talking, Reading, and Counting together 6) Social and Emotional Development 7) Review Module. The program is meant to be completed over approximately three months, and caregivers in the program will meet with a coach on a weekly or bi-weekly basis to discuss what they learned in the modules and how to practice it in their daily lives.

Primary outcome measure

  • System Usability Scale [ Time Frame: 3 months post-enrollment ]
  • Intervention Appropriateness Measure (IAM) [ Time Frame: 3 Months Post-Enrollment ]
  • Acceptability of Intervention Measure (AIM) [ Time Frame: 3 Months Post-Enrollment ]
  • Adapted Website Evaluation Questionnaire (WEQ) [ Time Frame: 3 months post-enrollment ]
  • Feasibility of the PLAY program [ Time Frame: 3 month post-enrollment (Phase I); 3 and 6 month post-enrollment (Phase II) ]

Central Contacts and Locations

Central contacts

Emily L Moscato, PhD

614-722-4724moscato_lab@nationwidechildrens.org

Cynthia Gerhardt, PhD

cynthia.gerhardt@nationwidechildrens.org

Locations

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Moscato Lab Email

614-722-4724moscatolab@nationwidechildrens.org

Principal Investigator:

Emily Moscato, PhD

More Information

Sponsor

Nationwide Children's Hospital

Last update posted

Nov 17, 2025

Last verified

Nov, 2025

Keywords

  • positive parenting
  • development
  • school readiness
  • digital health
  • caregiver stress
  • school advocacy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nationwide Children's Hospital on 2025-11-17.