Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06769334

Preparing for Life and Academics for Young Childhood Cancer Survivors

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.

Recruiting

Interested in participating?

Request Info

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location status: Recruiting

Location contact

Emily Moscato, PhD

PRINCIPAL_INVESTIGATOR

Moscato Lab Email

CONTACT

[email protected]

614-722-4724

About this study

This study will occur in two phases. Phase I will involve rapid cycle testing of the intervention and Phase II will be a single-arm trial of the PLAY program.

For phase I, the aim of this study is to refine PLAY to optimize feasibility and acceptability (ORBIT Phase Ib) through rapid-cycle testing with families of YCCS (n=5 per group, up to 15 total) in partnership with advisory boards comprised of 10 families of YCCS, including rural and Appalachian YCCS, and 10 healthcare providers ("co-designers"). Rapid cycle testing to iteratively refine PLAY will determine its optimal timing, dose, and duration until three caregivers sequentially endorse above-average usability (System Usability Scale score >68), feasibility, and acceptability ratings (>80%), or up to n=15 families have completed the PLAY program.

Following rapid cycle testing, phase II will involve a single-arm trial of PLAY program with up to 20 new families of YCCS to evaluate the refined program's feasibility, acceptability, and proof-of-concept. Caregivers will be recruited and will participate using analogous procedures and measures, as described in Phase I, with the addition of 6-month post-baseline assessments.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PLAY Program

Other

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 outcomes

  1. System Usability Scale

    Time frame: 3 months post-enrollment

    This is a 10-item measure that will quantitatively assess usability of our web-based program. The SUS measures how accessible the website is and whether participants can understand the content of the website on a scale of 0-100. We will continue to recruit until our website has achieved an average score of >68% (above average).

  2. Intervention Appropriateness Measure (IAM)

    Time frame: 3 Months Post-Enrollment

    Participants will use this four-item measure to rate the appropriateness of the PLAY program. Each item is rated from 1-5 and the final score for the measure is the average number for all answers. A higher score means a participant rated the PLAY program as more appropriate, an overall score of 4 or higher (80%) means a participant found the program to be appropriate.

  3. Acceptability of Intervention Measure (AIM)

    Time frame: 3 Months Post-Enrollment

    This is a four-item measure that will have participants rate the acceptability of the PLAY program. Each item is rated from 1-5 and the final score for the measure is the average number for all answers. A higher score means a participant rated the PLAY program as more acceptable, an overall score of 4 or higher (80%) means a participant found the program to be acceptable.

  4. Adapted Website Evaluation Questionnaire (WEQ)

    Time frame: 3 months post-enrollment

    This measure will assess accessibility and satisfaction with the PLAY Program. Four overall items will be rated from 1-10 by participants. The overall score will be the average response across items. A higher score indicates higher satisfaction with the program. Overall scores of 8 or higher (> 80%) are an indication of satisfaction with the PLAY program.

  5. Feasibility of the PLAY program

    Time frame: 3 month post-enrollment (Phase I); 3 and 6 month post-enrollment (Phase II)

    Enrollment rate (#enrolled/#approached; milestone greater than or equal to 50%), completion rate (# completing core PLAY sessions/#enrolled; milestone greater than or equal to 75%), retention rate (#completers of 3 and 6 month assessments/ # enrolled at baseline; milestone greater than or equal to 70%); Caregivers who rate the intervention greater than or equal to 80% on the Feasibility Intervention Measure (FIM; milestone >80%), which is a four-item measure. Each item is rated from 1-5 and the final score for the measure is the average number for all answers. A higher score means a participant rated the PLAY program as more feasible, an overall score of 4 or higher (80%) means a participant found the program to be feasible.

Secondary outcomes

  1. Play and Alternative Learning Strategies parent-child interaction coding

    Time frame: Baseline, 3 and 6 month follow up (Phase II)

    Caregivers will record themselves playing with with their child for at least 10 minutes for a measure of observed positive parenting behaviors which will be rated with the standardized Play and Learning Strategies coding scheme by trained raters blinded to timepoint. The coding scheme involves 1 to 5 Likert scale ratings of positive parenting behaviors (i.e., warmth, contingent responsiveness, maintaining, verbal scaffolding, demonstration/physical teaching). Proof of concept will be determined if 8 of 15 caregivers demonstrate improvements by greater than 1 point on observed positive parenting behaviors from baseline.

  2. Parenting Stress Index-Short Form

    Time frame: Baseline, 3 and 6 months post-enrollment (Phase II)

    Caregivers will complete the Parenting Stress Inventory, Short Form (PSI-SF), yielding a Total Parenting Stress Score. Proof-of-concept will be determined if at least 8 of 15 caregivers report either maintenance of non-clinical levels of parenting stress or reduction to non-clinical levels post-intervention (i.e., Total Parenting Stress < 85th percentile).

  3. Hospital Depression and Anxiety Scale (HADS)

    Time frame: Baseline, 3 and 6 months post-enrollment (Phase II)

    Caregivers will complete the Hospital Anxiety and Depression Scale (HADS) which yields Anxiety and Depression Total Scores. Proof-of-concept will be determined if at least 8 of 15 caregivers report either maintenance of non-clinical levels of anxiety/depression or reduction to non-clinical levels post-intervention (i.e., HADS scores less than a score of 8).

Other outcomes

  1. Behavior Rating Inventory of Executive Function (BRIEF-P or -2)

    Time frame: Baseline, 3 and 6 months post-enrollment (Phase II)

    Caregivers and teachers will complete the Behavior Rating Inventory of Executive Function, Preschool (BRIEF-P; ages 2 to 5 years) or the BRIEF-2 (ages 5 years+), yielding a General Executive Composite. Proof of concept will be determined if 8 of 15 caregivers and teachers report either that the child has maintained non-clinical levels of executive functioning problems or has reduced executive functioning problems to the non-clinical range post-intervention (i.e., General Executive Composite T-score less than or equal to 65).

  2. Adaptive Behavior Assessment System, Third Edition (ABAS-3; Pre-Academics or Functional Academics subscale)

    Time frame: Baseline, 3 and 6 months post-enrollment (Phase II)

    Caregivers and teachers will also complete the Adaptive Behavior Assessment System, Third Edition (ABAS-3; Pre-Academics or Functional Academics subscale). Proof of concept will be determined if 8 of 15 caregivers and teachers either report that the child has maintained on track performance for pre-academic skills, or has improved in their pre-academic skills to a non-delayed range (i.e., scaled score greater than or equal to 6).

Study contacts

Contact information is provided by the study sponsor or research team.

Cynthia Gerhardt, PhD

CONTACT

[email protected]

Emily L Moscato, PhD

CONTACT

[email protected]

614-722-4724

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Digital Health Intervention to Improve Neurodevelopmental Outcomes for Young Childhood Cancer Survivors in Underserved Communities

Acronym: PLAY

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 10, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.