Recruiting

FaceSay

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT07923370

Conditions

Survivors of Pediatric Brain Tumors

Pediatric Cancer

Eligibility Criteria

Sex: All

Age: 6 - 13

Healthy Volunteers: Not accepted

Interventions

FaceSay

SuccessMaker Reading

Study Details

Brief 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.

Conditions

Survivors of Pediatric Brain Tumors

Pediatric Cancer

Study ID

NCT07923370

Start date

Oct 30, 2025

Status verified date

Nov, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 13

Healthy Volunteers: Not accepted

Inclusion Criteria:

Eligible participants are SPBT who:

1. are between the ages 6-13
2. completed some form of tumor-directed treatment (surgery, chemotherapy, and/or radiation therapy)
3. are off tumor-directed therapy
4. demonstrate difficulties on at least one of the following:

1. 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
2. Social Responsiveness Scale-2 (SRS-2): T-score above 60 on any scale
3. Child Behavior Checklist (CBCL): T-score below 30 on social competence scale or T-score above 64 on social problems subscale

Exclusion Criteria:

Ineligible participants are individuals who:

1. have a genetic condition affecting neurocognitive or social function, or severe developmental delays (excluding NF1, ASD, and Moya Moya)
2. 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: FaceSay

Beginning 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.

active comparator: SuccessMaker Reading

Beginning 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.

Interventions

FaceSay

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 Reading

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.

Primary outcome measure

  • FaceSay Feasibility and Acceptability: Enrollment Rates [ Time Frame: Across recruitment outreach period, up to 5 no-response contacts ]
  • FaceSay Feasibility and Acceptability: Training Completion Rate [ Time Frame: 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. ]
  • FaceSay Feasibility and Acceptability: Intervention Acceptability [ Time Frame: Parent reports of the intervention across their 6-week training period will be assessed at their T2 follow-up visit. ]

Central Contacts and Locations

Central contacts

Matthew Hocking, PhD (Clinical Psychology)

267-426-5561hockingm@chop.edu

Manali Zope, BS (Biological Sciences)

267-425-0174zopem@chop.edu

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19335

Contacts

Manali Zope, BS (Biological Sciences)

267-425-0174zopem@chop.edu

Principal Investigator:

Matthew Hocking, PhD (Clinical Psychology)

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Nov 6, 2026

Last verified

Nov, 2026

Keywords

  • Pediatric Cancer
  • Social Functioning
  • Digital Social Intervention
  • Facial Affect Recognition
  • Social Information Processing
  • Pediatric Brain Tumor Survivor
  • Cancer Survivorship

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-07. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2026-11-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.