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Survivors of Pediatric Brain TumorsFEATURENCT07923370

Facial Expression Awareness Training to Understand and Recognize Emotions

A study testing FaceSay and SuccessMaker Reading in people with Survivors of Pediatric Brain Tumors and Pediatric Cancer, run by Children's Hospital of Philadelphia at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this research is to find out if a computer-based treatment program, called FaceSay, is a feasible and effective intervention for survivors of pediatric brain tumors (SPBT). The goal of this intervention is to improve survivors' facial affect recognition, social attention, and social adjustment. Read more about this study

Who is it for?
Ages 6 to 13 years
What is being tested?
FaceSay and SuccessMaker Reading
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
30 Oct 2025to Dec 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 6 to 13 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Eligible participants are SPBT who:
  • are between the ages 6-13
  • completed some form of tumor-directed treatment (surgery, chemotherapy, and/or radiation therapy)
  • are off tumor-directed therapy
  • demonstrate difficulties on at least one of the following:
  • Parent- or self-rated Patient-Reported Outcomes Measurement Information System (PROMIS) Peer Relationships Short Form: T-score 1 standard deviation below the mean, which translates to T scores of 40 or below
  • Social Responsiveness Scale-2 (SRS-2): T-score above 60 on any scale
  • Child Behavior Checklist (CBCL): T-score below 30 on social competence scale or T-score above 64 on social problems subscale

Who cannot join

  • Ineligible participants are individuals who:
  • have a genetic condition affecting neurocognitive or social function, or severe developmental delays (excluding NF1, ASD, and Moya Moya)
  • are non-English speaking (FaceSay is only available in English and some assessments only have been validated in English)
  • 4) a motor or visual limitation that precludes computer use

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Matthew Hocking, PhD (Clinical Psychology) contact

267-426-5561

hockingm@chop.edu

Manali Zope, BS (Biological Sciences) contact

267-425-0174

zopem@chop.edu

United States1 site, 1 recruiting
  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19335

    Manali Zope, BS (Biological Sciences), 267-425-0174, zopem@chop.edu

    Matthew Hocking, PhD (Clinical Psychology)

    Recruiting

Other trials in United States

About this study

Official title: The FEATURE Study: Facial Expression Awareness Training to Understand and Recognize Emotions

The purpose of this research is to find out if a computer-based treatment program, called FaceSay, is a feasible and effective intervention for survivors of pediatric brain tumors (SPBT). The goal of this intervention is to improve survivors' facial affect recognition, social attention, and social adjustment.

Read the detailed description

The proposed research is for a pilot randomized clinical trial (RCT) of a face processing intervention, FaceSay, compared to an active control condition in SPBT who demonstrate peer-related social difficulties that are similar to autistic youth. Using a randomized, active control trial with a 1:1: randomization, this study will evaluate the feasibility and acceptability of the intervention with SPBT and estimate the effects of the program on key social functioning domains. Participants will be randomized into either the FaceSay condition or an active control condition, SuccessMaker, which is an online academic skill-building program. Participants will be evaluated at baseline prior to the intervention (T1), immediately after the intervention (T2), and 3 months later (T3). The study duration per subject will be approximately 18 weeks including 3 in-person study visits and the 6-week intervention period. This is a single-site study with all potential participants being recruited from the Neuro-Oncology program at the Children's Hospital of Philadelphia (CHOP). The goal is to randomize 40 participants in this pilot study.

Being tested
FaceSay, SuccessMaker Reading
Keywords
Pediatric Cancer, Social Functioning, Digital Social Intervention, Facial Affect Recognition, Social Information Processing, Pediatric Brain Tumor Survivor, Cancer Survivorship
Medical subject headings
Neoplasms, Social Adjustment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FaceSayDevice

    FaceSay (http://www.facesay.com/) is a computer-delivered, software program to enhance face processing in youth, a core component of social information processing (SIP). The training occurs in a game-like environment that repeatedly challenges different aspects of face processing. FaceSay contains three different games that target various skills. "Amazing Gazing" targets users' eye gaze and joint attention and requires users to respond based on the game character's eye gaze. In the game "Band Aid Clinic," users reconstruct a game character's face by applying the correct band aid that includes pictures of facial features. This game promotes processing of facial expressions through different facial features and configurations. The final game, "Follow the Leader," requires users to match facial expressions from one game character to another. As the user advances, the facial expressions become increasingly subtle and more challenging.

  • SuccessMaker ReadingDevice

    SuccessMaker: SuccessMaker is an online, academic skills building program. Using adaptive lessons tailored to the participant's reading level, SuccessMaker aims to enhance understanding in phonological awareness, phonics, fluency, vocabulary, comprehension, and concepts of print. The program adapts to the performance of the user across areas to introduce new skills when appropriate to the user. SuccessMaker targets different domains than by FaceSay and those not associated with social difficulties. SuccessMaker uses adaptive lessons tailored to the participant's reading level to enhance understanding in phonological awareness, phonics, fluency, vocabulary, comprehension, and concepts of print. The program adapts to the performance of the user across areas to introduce new skills when appropriate to the user.

Study groups in NCT07923370
Study groupRoleWhat they receive
FaceSayExperimentalBeginning within two weeks of baseline testing, participants will be asked to complete two 20-minute sessions of FaceSay per week for 6 weeks (12 sessions total), which is identical to prior FaceSay trials. Research staff will conduct brief, weekly phone or telehealth-based check-ins during training to monitor progress and discuss strategies to support engagement with the programs.
Receives: Device: FaceSay
SuccessMaker ReadingActive comparatorBeginning within two weeks of baseline testing, participants will be asked to complete two 20-minute sessions of SuccessMaker Reading per week for 6 weeks (12 sessions total), which is identical to prior FaceSay trials. Research staff will conduct brief, weekly phone or telehealth-based check-ins during training to monitor progress and discuss strategies to support engagement with the programs.
Receives: Device: SuccessMaker Reading

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FaceSay Feasibility and Acceptability: Enrollment Rates

    Survivors and families will demonstrate interest in FaceSay, as defined by at least 75% of those approached enrolling in the study.

    Measured: Across recruitment outreach period, up to 5 no-response contacts

  2. FaceSay Feasibility and Acceptability: Training Completion Rate

    FaceSay will be feasible, as defined by 75% of randomized participants achieving over 80% treatment adherence (i.e., 10 of 12 training sessions over a 6-week period).

    Measured: Training completion will be tracked for each participant across 6 weeks. A final completion rate for each participant will be calculated at the end of the 6-week period.

  3. FaceSay Feasibility and Acceptability: Intervention Acceptability

    FaceSay will be acceptable, as defined by family reports of ease-of-use and satisfaction.

    Measured: Parent reports of the intervention across their 6-week training period will be assessed at their T2 follow-up visit.

Secondary outcomes (8)
  1. FaceSay Efficacy: Facial Identity Recognition Improvement

    At each time point, participants will be asked to complete the Victoria/Yale face processing assessment, which tests facial identity recognition skills. Overall accuracy scores (ranging from 0-100) for the facial identity recognition task will be used to quantify these skills, with higher scores reflecting better facial identity recognition.

    Measured: Enrollment to T3 (18 weeks)

  2. FaceSay Efficacy: Social Attention Improvement

    At each time point, participants doing in-person visits will complete a social attention paradigm that uses eye-tracking technology to capture the child's attention during a video of children playing. This task measures eye gaze during thirty-two 15-second videos depicting pairs of siblings engaging in either joint, cooperative or separate, parallel play. A Social Prioritization score will be calculated by subtracting the proportion of fixation time for background objects from the proportion of fixation time for faces. Higher Social Prioritization scores indicate more looking at faces and less looking at background objects. This task will only be completed for in-person study visits as it requires the use of a physical eye tracking device.

    Measured: Enrollment to T3 (18 weeks)

  3. FaceSay Efficacy: Social Deficits Improvement

    At each time point, caregivers of participants will complete the Social Responsiveness Scale, 2nd Edition (SRS- 2). The SRS-2 is a 65-item parent-report questionnaire that evaluates the frequency of reciprocal social behaviors, communication, and repetitive and stereotypic behaviors in the child. The school-age form (for ages 4-18 years) will be used. The questionnaire yields a single summary T-score that can be used as an index of the child's severity of social deficits, with higher scores indicating greater deficits.

    Measured: Enrollment to T3 (18 weeks)

  4. FaceSay Efficacy: Facial Expression Recognition Improvement

    At each time point, participants will be asked to complete the Victoria/Yale face processing assessment, which tests facial expression recognition skills. Overall accuracy scores (ranging from 0-100) for the facial expression recognition task will be used to quantify these skills, with higher scores reflecting better facial identity recognition.

    Measured: Enrollment to T3 (18 weeks)

  5. FaceSay Efficacy: Social Functioning Improvement

    At each time point, caregivers and youth will complete the Pediatric Quality of Life Inventory 4.0 (PedsQL). The PedsQL 4.0 is a 23-item measure broken down by participant age that examines physical, social, emotional, and school functioning over the past month. Scores from the social functioning sub-domain (ranging from 0-100) will be used to quantify social functioning, with higher scores indicating better social functioning.

    Measured: Enrollment to T3 (18 weeks)

  6. FaceSay Efficacy: Peer Relationship Improvement

    At each time point, caregivers and youth will complete the Patient Reported Outcomes Measurement Information System (PROMIS) Peer Relationships questionnaire. The PROMIS Peer Relationships questionnaire assesses the quality of the child's peer relationships. Overall T-scores for the measure will be assessed, with higher scores indicating better peer relationship quality.

    Measured: Enrollment to T3 (18 weeks)

  7. FaceSay Efficacy: Social Functioning Improvement

    At each time point, caregivers will complete the Childhood Behavioral Checklist (CBCL). The CBCL is a parent-report that evaluates a variety of behaviors in children including activities, school performance, and social interactions. T-scores from the social competence subdomain will be used to quantify social functioning, with higher scores reflecting better social functioning.

    Measured: Enrollment to T3 (18 weeks)

  8. FaceSay Efficacy: Social Information Processing

    At each time point, participants will complete the attribution and coping questionnaire which assess the child's attribution of peer's behaviors during hypothetical, ambiguous social interactions and their coping response. The percent of time the child choses each attribution and coping style will be assessed, and group differences in dominant styles will be assessed.

    Measured: Enrollment to T3 (18 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2026
  2. Study start30 Oct 2025
  3. Primary completionAug 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The proposed research is for a pilot randomized clinical trial (RCT) of a face processing intervention, FaceSay, compared to an active control condition, SuccessMaker, in SPBT.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07923370
Sponsor's protocol ID
25-023500
Acronym
FEATURE
Status last verified
Nov 2026
First submitted
5 Oct 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Desjardins L, Barrera M, Chung J, Cataudella D, Janzen L, Bartels U, Downie A, Fairclough D. Are we friends? Best friend nominations in pediatric brain tumor survivors and associated factors. Support Care Cancer. 2019 Nov;27(11):4237-4244. doi: 10.1007/s00520-019-04706-3. Epub 2019 Mar 8.

    PubMed 30847703
  • King AA, Seidel K, Di C, Leisenring WM, Perkins SM, Krull KR, Sklar CA, Green DM, Armstrong GT, Zeltzer LK, Wells E, Stovall M, Ullrich NJ, Oeffinger KC, Robison LL, Packer RJ. Long-term neurologic health and psychosocial function of adult survivors of childhood medulloblastoma/PNET: a report from the Childhood Cancer Survivor Study. Neuro Oncol. 2017 May 1;19(5):689-698. doi: 10.1093/neuonc/now242.

    PubMed 28039368
  • Brinkman TM, Ness KK, Li Z, Huang IC, Krull KR, Gajjar A, Merchant TE, Klosky JL, Partin RE, Tonning Olsson I, Boop F, Klimo P Jr, Chemaitilly W, Khan RB, Srivastava D, Robison LL, Hudson MM, Armstrong GT. Attainment of Functional and Social Independence in Adult Survivors of Pediatric CNS Tumors: A Report From the St Jude Lifetime Cohort Study. J Clin Oncol. 2018 Sep 20;36(27):2762-2769. doi: 10.1200/JCO.2018.77.9454. Epub 2018 Aug 9.

    PubMed 30091946
  • Ostrom QT, Cioffi G, Gittleman H, Patil N, Waite K, Kruchko C, Barnholtz-Sloan JS. CBTRUS Statistical Report: Primary Brain and Other Central Nervous System Tumors Diagnosed in the United States in 2012-2016. Neuro Oncol. 2019 Nov 1;21(Suppl 5):v1-v100. doi: 10.1093/neuonc/noz150.

    PubMed 31675094
  • Rice LM, Wall CA, Fogel A, Shic F. Computer-Assisted Face Processing Instruction Improves Emotion Recognition, Mentalizing, and Social Skills in Students with ASD. J Autism Dev Disord. 2015 Jul;45(7):2176-86. doi: 10.1007/s10803-015-2380-2.

    PubMed 25694364
  • Hopkins IM, Gower MW, Perez TA, Smith DS, Amthor FR, Wimsatt FC, Biasini FJ. Avatar assistant: improving social skills in students with an ASD through a computer-based intervention. J Autism Dev Disord. 2011 Nov;41(11):1543-55. doi: 10.1007/s10803-011-1179-z.

    PubMed 21287255
  • Hocking MC, Parish-Morris J, Schultz RT, Minturn JE, Brodsky C, Shabason EK, Herrington JD. Diminished social attention in pediatric brain tumor survivors: Using eye tracking technology during naturalistic social perception. Neuropsychology. 2020 Mar;34(3):350-358. doi: 10.1037/neu0000623. Epub 2020 Jan 30.

    PubMed 31999166
  • Moxon-Emre I, Farb NAS, Oyefiade AA, Bouffet E, Laughlin S, Skocic J, de Medeiros CB, Mabbott DJ. Facial emotion recognition in children treated for posterior fossa tumours and typically developing children: A divergence of predictors. Neuroimage Clin. 2019;23:101886. doi: 10.1016/j.nicl.2019.101886. Epub 2019 Jun 12.

    PubMed 31254938
  • Hocking MC, Schultz RT, Minturn JE, Brodsky C, Albee M, Herrington JD. Reduced Fusiform Gyrus Activation During Face Processing in Pediatric Brain Tumor Survivors. J Int Neuropsychol Soc. 2022 Oct;28(9):937-946. doi: 10.1017/S135561772100117X. Epub 2021 Oct 4.

    PubMed 34605383
  • Hocking MC, Noll RB, Kazak AE, Brodsky C, Phillips P, Barakat LP. Friendships in Pediatric Brain Tumor Survivors and Non-Central Nervous System Tumor Survivors. J Pediatr Psychol. 2020 Mar 1;45(2):194-202. doi: 10.1093/jpepsy/jsz101.

    PubMed 31925436
  • Fantozzi PM, Anil A, McHugh S, Srsich AR, Zope M, Parish-Morris J, Schultz RT, Herrington J, Hocking MC. Social impairment in survivors of pediatric brain tumors via reduced social attention and emotion-specific facial expression recognition. Pediatr Blood Cancer. 2024 Jun;71(6):e30943. doi: 10.1002/pbc.30943. Epub 2024 Mar 12.

    PubMed 38470289
  • Yeates KO, Bigler ED, Dennis M, Gerhardt CA, Rubin KH, Stancin T, Taylor HG, Vannatta K. Social outcomes in childhood brain disorder: a heuristic integration of social neuroscience and developmental psychology. Psychol Bull. 2007 May;133(3):535-56. doi: 10.1037/0033-2909.133.3.535.

    PubMed 17469991
  • Vannatta K, Gartstein MA, Short A, Noll RB. A controlled study of peer relationships of children surviving brain tumors: teacher, peer, and self ratings. J Pediatr Psychol. 1998 Oct;23(5):279-87. doi: 10.1093/jpepsy/23.5.279.

    PubMed 9782676
  • Hocking MC, Albee M, Brodsky C, Shabason E, Wang L, Schultz RT, Herrington J. Face Processing and Social Functioning in Pediatric Brain Tumor Survivors. J Pediatr Psychol. 2021 Oct 18;46(10):1267-1275. doi: 10.1093/jpepsy/jsab067.

    PubMed 34313751
  • Hocking MC, Quast LF, Brodsky C, Deatrick JA. Caregiver perspectives on the social competence of pediatric brain tumor survivors. Support Care Cancer. 2017 Dec;25(12):3749-3757. doi: 10.1007/s00520-017-3805-6. Epub 2017 Jul 8.

    PubMed 28689249

Questions about this trial

What is this clinical trial studying?

A study testing FaceSay and SuccessMaker Reading in people with Survivors of Pediatric Brain Tumors and Pediatric Cancer, run by Children's Hospital of Philadelphia 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 8 inclusion and 4 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 6 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 Matthew Hocking, PhD (Clinical Psychology) (267-426-5561, hockingm@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FaceSay Feasibility and Acceptability: Enrollment Rates (time frame: Across recruitment outreach period, up to 5 no-response contacts). The study lists 3 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 NCT07923370, which also lists 16 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 6 Nov 2026.

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