Childhood CancerPLAYNCT06769334
Preparing for Life and Academics for Young Childhood Cancer Survivors
A study testing PLAY Program in people with Childhood Cancer, run by Nationwide Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Childhood Cancer
- What is being tested?
- PLAY Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2024to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cynthia Gerhardt, PhD contact
United States1 site, 1 recruiting
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Moscato Lab Email, 614-722-4724, moscatolab@nationwidechildrens.org
Emily Moscato, PhD
About this study
Official title: Digital Health Intervention to Improve Neurodevelopmental Outcomes for Young Childhood Cancer Survivors in Underserved Communities
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:
- Are caregivers of childhood cancer survivors willing to participate in the PLAY program and complete assessments before and after the program?
- Do caregivers of childhood cancer survivors rate the PLAY program as easy to use?
- Are caregivers of childhood cancer survivors satisfied with the PLAY program?
- How can the PLAY program be improved in the future?
- Does PLAY help improve how caregivers interact and read with their children or how they manage their own stress?
Read more
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.
Read the detailed description
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.
- Conditions
- Childhood Cancer
- Being tested
- PLAY Program
- Keywords
- positive parenting, development, school readiness, digital health, caregiver stress, school advocacy
- Medical subject headings
- Neoplasms, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLAY ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Preparing for Life and Academics for Young (PLAY) survivors program | Experimental | 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. Receives: Other: PLAY Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale
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).
Measured: 3 months post-enrollment
Intervention Appropriateness Measure (IAM)
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.
Measured: 3 Months Post-Enrollment
Acceptability of Intervention Measure (AIM)
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.
Measured: 3 Months Post-Enrollment
Adapted Website Evaluation Questionnaire (WEQ)
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.
Measured: 3 months post-enrollment
Feasibility of the PLAY program
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.
Measured: 3 month post-enrollment (Phase I); 3 and 6 month post-enrollment (Phase II)
Secondary outcomes (3)
Play and Alternative Learning Strategies parent-child interaction coding
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.
Measured: Baseline, 3 and 6 month follow up (Phase II)
Parenting Stress Index-Short Form
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).
Measured: Baseline, 3 and 6 months post-enrollment (Phase II)
Hospital Depression and Anxiety Scale (HADS)
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).
Measured: Baseline, 3 and 6 months post-enrollment (Phase II)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start12 Dec 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (71)Papers the sponsor has linked to this study.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Emily Moscato, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769334
- Sponsor's protocol ID
- STUDY00004302
- Other IDs
- K08CA290060
- Acronym
- PLAY
- Status last verified
- Oct 2026
- First submitted
- 6 Jan 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected, deidentified quantitative IPD for the primary and secondary outcomes of the study for participants who consent to have their data shared.
Publications
Moscato EL, Darow E, Quach J, M Winning A, Schmidt M, Wade SL, Gerhardt CA, Sezgin E. Usability Testing of an Internet-Based Responsive Parenting Program for Caregivers of Young Survivors of Childhood Cancer Living in Rural and Appalachian Communities: Mixed Methods Study. JMIR Pediatr Parent. 2025 Aug 5;8:e70055. doi: 10.2196/70055.
PubMed 40764035Yao N, Alcala HE, Anderson R, Balkrishnan R. Cancer Disparities in Rural Appalachia: Incidence, Early Detection, and Survivorship. J Rural Health. 2017 Sep;33(4):375-381. doi: 10.1111/jrh.12213. Epub 2016 Sep 7.
PubMed 27602545Wochos GC, Semerjian CH, Walsh KS. Differences in parent and teacher rating of everyday executive function in pediatric brain tumor survivors. Clin Neuropsychol. 2014;28(8):1243-57. doi: 10.1080/13854046.2014.971875. Epub 2014 Oct 24.
PubMed 25343533Winter AL, Conklin HM, Tyc VL, Stancel H, Hinds PS, Hudson MM, Kahalley LS. Executive function late effects in survivors of pediatric brain tumors and acute lymphoblastic leukemia. J Clin Exp Neuropsychol. 2014;36(8):818-30. doi: 10.1080/13803395.2014.943695. Epub 2014 Aug 15.
PubMed 25126830Willard VW, Qaddoumi I, Zhang H, Huang L, Russell KM, Brennan R, Wilson MW, Rodriguez-Galindo C, Phipps S. A longitudinal investigation of parenting stress in caregivers of children with retinoblastoma. Pediatr Blood Cancer. 2017 Apr;64(4):10.1002/pbc.26279. doi: 10.1002/pbc.26279. Epub 2016 Nov 3.
PubMed 27808461Willard VW, Gordon ML, Means B, Brennan RC, Conklin HM, Merchant TE, Vinitsky A, Harman JL. Social-Emotional Functioning in Preschool-Aged Children With Cancer: Comparisons Between Children With Brain and Non-CNS Solid Tumors. J Pediatr Psychol. 2021 Aug 11;46(7):790-800. doi: 10.1093/jpepsy/jsab018.
PubMed 33682007Willard VW, Cox LE, Russell KM, Kenney A, Jurbergs N, Molnar AE Jr, Harman JL. Cognitive and Psychosocial Functioning of Preschool-Aged Children with Cancer. J Dev Behav Pediatr. 2017 Oct;38(8):638-645. doi: 10.1097/DBP.0000000000000512.
PubMed 28937451Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459Ward R, Reynolds JE, Pieterse B, Elliott C, Boyd R, Miller L. Utilisation of coaching practices in early interventions in children at risk of developmental disability/delay: a systematic review. Disabil Rehabil. 2020 Oct;42(20):2846-2867. doi: 10.1080/09638288.2019.1581846. Epub 2019 Apr 25.
PubMed 31021669Wade SL, Cassedy AE, Shultz EL, Zang H, Zhang N, Kirkwood MW, Stancin T, Yeates KO, Taylor HG. Randomized Clinical Trial of Online Parent Training for Behavior Problems After Early Brain Injury. J Am Acad Child Adolesc Psychiatry. 2017 Nov;56(11):930-939.e2. doi: 10.1016/j.jaac.2017.09.413. Epub 2017 Sep 14.
PubMed 29096775Vance YH, Eiser C. The school experience of the child with cancer. Child Care Health Dev. 2002 Jan;28(1):5-19. doi: 10.1046/j.1365-2214.2002.00227.x.
PubMed 11856182Van Schoors M, Caes L, Knoble NB, Goubert L, Verhofstadt LL, Alderfer MA; Guest Editors: Cynthia A. Gerhardt, Cynthia A. Berg, Deborah J. Wiebe and Grayson N. Holmbeck. Systematic Review: Associations Between Family Functioning and Child Adjustment After Pediatric Cancer Diagnosis: A Meta-Analysis. J Pediatr Psychol. 2017 Jan 1;42(1):6-18. doi: 10.1093/jpepsy/jsw070.
PubMed 28173163Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
PubMed 12914662Schorr E, Wade SL, Taylor HG, Stancin T, Yeates KO. Parenting styles as a predictor of long-term psychosocial outcomes after traumatic brain injury (TBI) in early childhood. Disabil Rehabil. 2020 Aug;42(17):2437-2443. doi: 10.1080/09638288.2019.1602676. Epub 2019 Apr 21.
PubMed 31006276Rodriguez EM, Dunn MJ, Zuckerman T, Vannatta K, Gerhardt CA, Compas BE. Cancer-related sources of stress for children with cancer and their parents. J Pediatr Psychol. 2012 Mar;37(2):185-97. doi: 10.1093/jpepsy/jsr054. Epub 2011 Aug 13.
PubMed 21841187
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Health Intervention to Improve Neurodevelopmental Outcomes for Young Childhood Cancer Survivors in Underserved Communities
- ClinicalTrials.gov ID
- NCT06769334
- Acronym / sponsor ID
- PLAY / STUDY00004302
- Conditions
- Childhood Cancer
- Keywords
- positive parenting, development, school readiness, digital health, caregiver stress, school advocacy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Are caregivers of childhood cancer survivors willing to participate in the PLAY program and complete assessments before and after the program?
- Do caregivers of childhood cancer survivors rate the PLAY program as easy to use?
- Are caregivers of childhood cancer survivors satisfied with the PLAY program?
- How can the PLAY program be improved in the future?
- 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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preparing for Life and Academics for Young (PLAY) survivors program | Experimental | Other: PLAY ProgramPLAY 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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
- Classroom or daycare teacher of the childhood cancer survivor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLAY ProgramThe 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. | Other | Preparing for Life and Academics for Young (PLAY) survivors program |
Primary outcome
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).
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.
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.
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.
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.
3 secondary outcomes
Play and Alternative Learning Strategies parent-child interaction coding
Time frame: Baseline, 3 and 6 month follow up (Phase II)
Parenting Stress Index-Short Form
Time frame: Baseline, 3 and 6 months post-enrollment (Phase II)
Hospital Depression and Anxiety Scale (HADS)
Time frame: Baseline, 3 and 6 months post-enrollment (Phase II)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 40764035Moscato EL, Darow E, Quach J, M Winning A, Schmidt M, Wade SL, Gerhardt CA, Sezgin E. Usability Testing of an Internet-Based Responsive Parenting Program for Caregivers of Young Survivors of Childhood Cancer Living in Rural and Appalachian Communities: Mixed Methods Study. JMIR Pediatr Parent. 2025 Aug 5;8:e70055. doi: 10.2196/70055.
- Background: PubMed 27602545Yao N, Alcala HE, Anderson R, Balkrishnan R. Cancer Disparities in Rural Appalachia: Incidence, Early Detection, and Survivorship. J Rural Health. 2017 Sep;33(4):375-381. doi: 10.1111/jrh.12213. Epub 2016 Sep 7.
- Background: PubMed 25343533Wochos GC, Semerjian CH, Walsh KS. Differences in parent and teacher rating of everyday executive function in pediatric brain tumor survivors. Clin Neuropsychol. 2014;28(8):1243-57. doi: 10.1080/13854046.2014.971875. Epub 2014 Oct 24.
- Background: PubMed 25126830Winter AL, Conklin HM, Tyc VL, Stancel H, Hinds PS, Hudson MM, Kahalley LS. Executive function late effects in survivors of pediatric brain tumors and acute lymphoblastic leukemia. J Clin Exp Neuropsychol. 2014;36(8):818-30. doi: 10.1080/13803395.2014.943695. Epub 2014 Aug 15.
- Background: PubMed 27808461Willard VW, Qaddoumi I, Zhang H, Huang L, Russell KM, Brennan R, Wilson MW, Rodriguez-Galindo C, Phipps S. A longitudinal investigation of parenting stress in caregivers of children with retinoblastoma. Pediatr Blood Cancer. 2017 Apr;64(4):10.1002/pbc.26279. doi: 10.1002/pbc.26279. Epub 2016 Nov 3.
- Background: PubMed 33682007Willard VW, Gordon ML, Means B, Brennan RC, Conklin HM, Merchant TE, Vinitsky A, Harman JL. Social-Emotional Functioning in Preschool-Aged Children With Cancer: Comparisons Between Children With Brain and Non-CNS Solid Tumors. J Pediatr Psychol. 2021 Aug 11;46(7):790-800. doi: 10.1093/jpepsy/jsab018.
- Background: PubMed 28937451Willard VW, Cox LE, Russell KM, Kenney A, Jurbergs N, Molnar AE Jr, Harman JL. Cognitive and Psychosocial Functioning of Preschool-Aged Children with Cancer. J Dev Behav Pediatr. 2017 Oct;38(8):638-645. doi: 10.1097/DBP.0000000000000512.
- Background: PubMed 28851459Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Background: PubMed 31021669Ward R, Reynolds JE, Pieterse B, Elliott C, Boyd R, Miller L. Utilisation of coaching practices in early interventions in children at risk of developmental disability/delay: a systematic review. Disabil Rehabil. 2020 Oct;42(20):2846-2867. doi: 10.1080/09638288.2019.1581846. Epub 2019 Apr 25.
- Background: PubMed 29096775Wade SL, Cassedy AE, Shultz EL, Zang H, Zhang N, Kirkwood MW, Stancin T, Yeates KO, Taylor HG. Randomized Clinical Trial of Online Parent Training for Behavior Problems After Early Brain Injury. J Am Acad Child Adolesc Psychiatry. 2017 Nov;56(11):930-939.e2. doi: 10.1016/j.jaac.2017.09.413. Epub 2017 Sep 14.
- Background: PubMed 11856182Vance YH, Eiser C. The school experience of the child with cancer. Child Care Health Dev. 2002 Jan;28(1):5-19. doi: 10.1046/j.1365-2214.2002.00227.x.
- Background: PubMed 28173163Van Schoors M, Caes L, Knoble NB, Goubert L, Verhofstadt LL, Alderfer MA; Guest Editors: Cynthia A. Gerhardt, Cynthia A. Berg, Deborah J. Wiebe and Grayson N. Holmbeck. Systematic Review: Associations Between Family Functioning and Child Adjustment After Pediatric Cancer Diagnosis: A Meta-Analysis. J Pediatr Psychol. 2017 Jan 1;42(1):6-18. doi: 10.1093/jpepsy/jsw070.
- Individual participant dataSharing planned: Yes. All collected, deidentified quantitative IPD for the primary and secondary outcomes of the study for participants who consent to have their data shared.
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Knowledge, Attitudes, Practice
Recruiting
Facial Expression Awareness Training to Understand and Recognize Emotions
Survivors of Pediatric Brain Tumors, Pediatric Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cynthia Gerhardt, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLAY Program in people with Childhood Cancer, run by Nationwide Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily L Moscato, PhD (614-722-4724, moscato_lab@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (time frame: 3 months post-enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06769334, which also lists 71 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.