The PediQUEST Response to Pain Of Children With Neurologic Disability Pilot Randomized Controlled Trial
Key facts
- Who runs it
- Massachusetts General Hospital
- Where
- Birmingham and Boston, United StatesSee the 3 sitesAlso in 1 other country, 1 site
- Trial code
- Status
- Completed
- People taking part
- 54 people enrolled
- Started
- 8 May 2024
- Ended
- 31 Jul 2025
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- PediQUEST ResPOND
- Record updated
- 21 January 2026
Who can take part
- Age
- 1 year and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Parent-child dyads will be included based on the following criteria:; Child participants will be selected from the base population of patients who are:
- ≥ 1 year old,
- receiving routine (ongoing) care at Boston Children's Hospital, AND
- followed by the Neurology, Cerebral Palsy or Complex Care services; All patients from the base population will be screened to include any patient who:
- has severe neurological impairment, defined as:; a Central Nervous System disorder resulting in motor and cognitive impairment and an inability to communicate either verbally or through sign language, AND; has complete caregiver dependency for activities of daily living AND
- date of diagnosis of SNI is ≥ 4 months prior to the date of screening
Who cannot take part
- Parent-child dyads will be excluded if any of the following apply:; the child,; is already followed by the palliative care team, OR; is not expected to survive at least 2 months after enrollment; OR; does not have "moderate to severe recurrent pain", as measured through the baseline Child Pain Survey (PPP). Specifically, we will exclude participants whose:
- "Good days" AND "Difficult days" PPP scores are <14, AND
- "Most troublesome pain" PPP score is <30, AND
- Number of "difficult days" are <8 in past month, AND
- Number of days with "most troublesome pain" are <4 in past month; OR • both parents,; do not have legal guardianship, OR; are unable to read, write, and speak English OR Spanish; are unable to understand and complete surveys
Where in United States
Also in 1 other country, 1 site
- University of Alabama BirminghamBirmingham, United StatesNo longer taking part
- Boston Children's HospitalBoston, United StatesNo longer taking part
- Dana-Farber Cancer InstituteBoston, United StatesNo longer taking part
About the trial
What the trial wants to find out
The goal of this pilot randomized controlled trial is to test the feasibility of running a full scale randomized controlled trial that compares the effect of the PQ-ResPOND intervention versus usual care to improve recurrent pain in children, adolescents, and young adults with severe neurologic impairment. The main questions it aims to answer are:
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* Is the study feasible and acceptable for participants? * Does PQ-ResPOND have a potential to be effective?
Participants will:
* answer surveys (their parents will) telling us about the child's pain, symptoms, and use of complementary therapies, and about their own psychological distress and satisfaction with care. * a group will receive the PQ-ResPOND intervention which consists of:
* activating parents and providers by using the PediQUEST system, a web platform that administers surveys and generates feedback reports alerting parents and providers about the child's experience, AND * responding to child pain or discomfort by incorporating the Response team (members of the hospital's palliative care team) into the child's care to privde a standardized approach to managing recurrent pain.
Researchers will use a comparison (control) group consisting of participants who will answer surveys and receive usual care (no feedback reports or consult with palliative care in this group) to see if a randomized design is feasible.
The 2 groups in the trial
- PQ-ResPOND (Intervention)Treatment being tested
Participants in the intervention arm will (i) answer weekly PQ-ResPOND Surveys over 12 weeks, (ii) receive feedback reports (generated by the PediQUEST system to summarize parents answers), and (iii) engage with the pediatric palliative care (PPC) team. The interprofessional PPC team will focus on child's recurrent pain and related symptoms using a standardized approach and work on family activation strategies.
Treatment: PediQUEST ResPOND
- Usual care (Control)No study treatment, for comparison
Participants randomized to the control arm will be assigned weekly PQ-ResPOND Surveys up to week 12. Participants in this arm will not have access to the full PediQUEST system, i.e. no reports will be generated. They will not meet the PPC team but can receive regular palliative care consultations following the site's usual referral procedures. Children in the usual care arm will receive standard care, which at Boston Children's Hospital usually involves several primary clinicians (primarily neurologists or Complex Care Service attending physicians) and access to psychosocial clinician care throughout the illness course. PPC referrals are typically made at the discretion of the primary clinician, often for decision making reasons and/or closer to end-of-life. If a child presents persistent distress, they will be cared through the usual mechanisms. The rationale for collecting weekly surveys is to minimize reporting bias and may increase adherence and retention.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Feasibility of The PediQUEST Response to Pain Of Children With Neurologic Disability (PQ-ResPOND) Intervention: a Pilot Randomized Controlled Trial (RCT)
- Record updated
- 21 January 2026