The study was registered at ClinicalTrials.gov (NCT05834725) on April 28, 2023. This study is a single-center pilot, 2-arm, RCT using a mixed methods approach (quantitative patient outcome measures combined with qualitative interview data). Participants are recruited from an outpatient pediatric rheumatology clinic and an interdisciplinary pain clinic at the Children’s Hospital of Philadelphia (CHOP) in Philadelphia, PA, USA. See Multimedia Appendix 1 for the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) checklist.

PRISM consists of 4 required skill-based sessions that focus on stress management, goal setting, cognitive restructuring, and benefit finding (see Figure 1). The optional fifth “coming together” session focuses on discussing with a family member, with the participant’s permission, the skills that the participant found beneficial, the ones they did not, and how they can continue to implement the skills learned in the future once the program finishes. Each session is around 30-50 minutes, with sessions scheduled 1-2 weeks apart. Participants are given access to “cheat sheets” and worksheets for each session and a mobile app that can be used to practice the skills learned.

PRISM coaches have a bachelor’s degree (at minimum), have gone through an 8-hour training and certification process for the administration of PRISM, and have practiced delivering the intervention with 2 peers to demonstrate competency. A standardized manual is used to guide PRISM coaches through each session and includes guided discussion prompts to facilitate rapport building and patient participation. Sessions are audio-recorded, and fidelity checks are conducted regularly by a supervisor. There is a standardized fidelity checklist used for scoring purposes and a safety plan to address psychological distress, as needed.

This study includes males and females aged ≥12 and <17 years who have a new diagnosis of CMP and are coming in person for a clinic visit, and one of their parents or legal guardians. Exclusion criteria include patients (1) with isolated and localized head pain or abdominal pain, (2) with a diagnosis of complex regional pain syndrome (CRPS), (3) currently receiving CBT, and (4) not capable of understanding the study or providing assent/consent.

Eligible participants are identified by study personnel through screening of the pediatric rheumatology and subspecialty pain clinic schedule via electronic medical records (EMRs). An EMR review is conducted to confirm eligibility, and if further information is needed, an in-person or telephone query is conducted to ensure eligibility. Study personnel approach the eligible patient and a parent or legal guardian at the time of their clinic visit or retroactively via telephone. The study is introduced using the Institutional Review Board (IRB)-approved informed consent form as guidance, and all questions are answered in accordance with IRB regulations. If the patient and their parent express interest but need more time to think about it, they fill out a contact information sheet, are provided with a consent form to take home, and are contacted after the clinic visit via telephone. If eligible and interested, they can provide electronic consent (e-consent) at the time of the clinic visit (Figure 2).

Those who are not approached at their clinic visit can be contacted retroactively via telephone and, if interested and eligible, can be e-consented via REDCap (Research Electronic Data Capture), a secure, web-based software platform designed to support data capture for research studies [24,25]. For anyone who declines participation, their reasoning is recorded in the study’s master log. Study personnel attempt to contact patient-caregiver dyads a maximum of 3 times before discontinuing recruitment efforts. Once baseline surveys are complete, the dyads will be randomly assigned to a study arm using a 1:1 allocation ratio: PRISM+usual care versus usual care.

Stratified randomization will be implemented by the study statistician in REDCap to ensure a balance in sex (male vs female) and clinic (rheumatology clinic vs interdisciplinary pain [amplified musculoskeletal pain] clinic) between the 2 study arms. The final randomization scheme will be prepared by a statistician independent of the study team to prevent bias. Study staff will not get access to randomization algorithms. Tracking of dyads and randomization will be recorded in the study’s master log.

Each enrolled participant’s medical chart will be reviewed by a study team member for information relevant to the study, including demographics, previous diagnoses, family medical history, previous surgeries, pain-related symptoms, and past treatment. Both members of each dyad will complete questionnaires at 0 months/time of enrollment; 3 months postenrollment or, if in the treatment group, immediately after intervention completion; and 9 months postenrollment. Questionnaires will be completed using an online REDCap survey. Participants will get 45 days to complete each set of questionnaires. Reminder emails or text messages (depending on participant preference) will be sent once a week to ensure completion, and reminder calls will be made a maximum of 3 times. Participants will be compensated for their time and completion of surveys. Caregivers will be paid US $20 for completion of survey 1, US $40 for completion of survey 2, and US $20 for completion of survey 3. Patient participants will be paid US $25 for completion of survey 1, US $50 for completion of survey 2, and US $25 for completion of survey 3. Should subjects request early termination, we will enumerate the next study survey as the final study survey and compensate participants with US $10 for completion of the final surveys. Next, we describe the study measures included in the questionnaires.

The patient measures are as follows:

The caregiver measures are as follows:

The study was approved by the CHOP IRB (IRB 22-020664; approval date April 21, 2023; most recent amendment #21 approved on May 8, 2025). The protocol was also reviewed by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at the NIH. Any further amendments to the study protocol will be communicated to the CHOP IRB and NIAMS at the NIH for formal approval.

Written informed consent will be obtained from all participants, as described in this protocol. All participants will provide informed consent by acknowledging that they have read and understood the consent form before randomization. Information about the study’s significance, purpose, procedures, risks, and benefits will be provided to all eligible patients during the consent process. Identifiable information will be collected from subjects and parent participants only to link the questionnaires and qualitative data from the interviews to the EMR data. Identifiable information linking individual subjects to their PHI (i.e., the master list) will be stored electronically in a Microsoft Excel file located on a secure research SAN drive for the duration of the study and will be maintained in keeping with CHOP policy. Research documents located on the SAN drive will be accessible only to members of the study team. Upon study completion, the database will be maintained in locked mode for a minimum of 3 years, as per regulatory guidelines. Data management procedures are included in our manual of operating procedures, which can be made available upon request.

Since the survey measures ask questions about mood, stressors, psychological symptoms, and feelings, this might put participants at risk for having negative thoughts and emotions. It is not likely that answering these survey measures will create additional distress beyond that which is already present, but research staff will offer referral for clinical services (for child or parent) for any reported distress warranting clinical attention. In addition, if during study participation, the study team discovers abuse or neglect or if threat to harm self or others occurs, they will follow established institutional procedures for mandatory reporting of this information and will provide referrals for appropriate clinical follow-up. We also have a data safety monitoring plan (DSMP) and a data safety monitoring board (DSMB). The DSMB consists of 4 members, who meet once a year to review study progress and safety or confidentiality concerns. In the unlikely event of an adverse outcome associated with this study protocol (eg, disclosure of patient information), it will be documented and discussed with the research team and promptly reported to the local IRB and study sponsor, if appropriate. Any serious adverse events will be reported to the local IRB and the DSMB within 48 hours and to the study sponsor.

Patients randomized to the treatment (PRISM+usual care) group will complete the first PRISM session within ~45 days of enrollment. Patients will complete the PRISM sessions remotely using a HIPAA (Health Insurance Portability and Accountability Act)-complaint videoconferencing platform. Each session will be scheduled approximately 1-2 weeks apart but must be completed within 45 days of the previous session. We will invite each patient-parent dyad to participate in an optional 30-minute semistructured interview (see Multimedia Appendix 2 for the interview guide) that will ask about their thoughts regarding PRISM, including background, timing, duration, attendance, content, sessions, and overall satisfaction. Participants will be purposively selected to enrich the cohort for those with early dropout and ensure representation of a variety of ages, races, and ethnicities. These interviews will be conducted by a study staff member other than the PRISM coach, and they will be audio-recorded and transcribed verbatim for qualitative assessment. Participants will be paid US $25 each for their time and completion of semistructured interviews.

This is the usual care group. This group will be assigned online questionnaires, as described earlier. Control group participants will not receive the PRISM intervention but will receive usual care. Although adolescent participants cannot be actively engaged in CBT at the time of enrollment, they will be allowed to start any type of mental health treatment recommended as part of their treatment plan for their CMP at any point during the study. Additionally recommended as part of usual care will be cardiovascular exercise and desensitization, which may include formal physical and occupational therapy. See Figure 3 for a comprehensive description of study visit activities and the timeline for both study arms.

The primary objective of this study is to determine whether PRISM, along with usual care, reduces functional disability more than usual care alone. The primary outcome or measure of efficacy is the FDI score at 3 months postrandomization (control group) or postintervention. The secondary efficacy outcomes are patient psychological distress (as measured with the K6), as well as the patient-reported pain intensity (as measured with the PROMIS Pediatric Numeric Rating Scale v1.0 – Pain Intensity). The secondary objectives are to determine a reduction in pain intensity and psychological distress with PRISM at intervention completion; determine reductions in functional disability, pain intensity, and psychological distress with PRISM at 6 months postintervention; evaluate potential patient- and caregiver-level moderators of PRISM; examine implementation outcomes (feasibility, acceptability, appropriateness); and identify facilitators of and barriers to engagement in PRISM.

The study team plans to publish the study findings in a peer-reviewed pediatrics, psychology, or rheumatology journal to disseminate the findings. No individually identifiable protected health information will be published. Summary results will be available on ClinicalTrials.gov.

This pilot RCT protocol is designed to assess whether the addition of PRISM to usual care is associated with greater improvements in functional disability compared to usual care alone. This intervention has the potential to enhance pain management and overall well-being for youth with CMP, who have been shown to have lower resilience than unaffected adolescents. The results of this study will heighten our understanding of the role of resilience over time and shed light on strategies that promote psychological resilience for patients with CMP and their caregivers. These insights will lay the groundwork for multicenter studies on the efficacy of PRISM in CMP and inform future treatment strategies for this population.

In terms of limitations of this protocol, it may be lacking in generalizability, as the population with CMP at our institution has been limited in racial and ethnic diversity. However, we do expect that our study sample will reflect the demographic makeup of patients with CMP within our clinic population. It is unclear based on the current literature whether our patient population aligns demographically with the population with CMP nationally. Our protocol is also limited to English-speaking participants. Offering PRISM in other languages would further increase the generalizability of future studies. Additionally, although pilot trial participants have approved of our flexibility in scheduling PRISM sessions outside of normal business hours, this may not be feasible in real-world clinical settings. Similarly, the 1-on-1 format of the intervention may be too time and resource intensive for routine clinical practice. This emphasizes the importance of future research to address these limitations and guide future implementation efforts.

Findings from this work will further enhance our understanding of psychosocial factors that play an important role in adolescent CMP, with the goal of reducing the disease burden and improving long-term outcomes. A future multicenter RCT of PRISM for adolescents with CMP will provide further evidence of the efficacy of this program and inform clinical implementation. For some adolescents, the addition of PRISM to routine clinical care could offer sufficient pain-coping skills to reduce their need for individual counseling. For others, these learned skills may serve as a critical interim until formal CBT becomes available. Although PRISM would not fully solve issues such as clinic wait times, the integration of PRISM into clinical care could help prioritize the limited appointments in pediatric chronic pain clinics for those with the greatest need for interdisciplinary care.