Cerebral Palsy InfantilePQ-ResPONDNCT06075797
The PediQUEST Response to Pain Of Children With Neurologic Disability Pilot Randomized Controlled Trial
A study testing PediQUEST ResPOND in people with Cerebral Palsy Infantile and Disabilities Multiple, run by Massachusetts General Hospital at 4 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Cerebral Palsy Infantile, Disabilities Multiple, Pain
- What is being tested?
- PediQUEST ResPOND
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 8 May 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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 join
- 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
Show all 12Show fewer
- "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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
University of Alabama, Birmingham
Birmingham, Alabama, 35294
Boston Children's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Feasibility of The PediQUEST Response to Pain Of Children With Neurologic Disability (PQ-ResPOND) Intervention: a Pilot Randomized Controlled Trial (RCT)
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:
- Is the study feasible and acceptable for participants?
- Does PQ-ResPOND have a potential to be effective?
Read more
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.
Read the detailed description
Background: In the US, tens of thousands of children, adolescents, and young adults (AYA) are estimated to live with severe neurologic impairment (SNI). Over 60% of these children endure uncontrolled and often persistent pain, which frequently goes unrecognized and untreated. The impact extends to their parents who commonly experience unremitting physical and psychological distress. There has been a lack of rigorous studies that focus on interventions to alleviate recurrent pain in children with SNI. This gap might be attributed to the stigmatization of these children, who are often from historically marginalized backgrounds, resulting in a low prioritization in research endeavors. To address this inequity and using the ORBIT Model for intervention development, the investigators have adapted and are refining an intervention previously applied in children with cancer. The PediQUEST Response to Pain Of children with Neurologic Disability (PQ-ResPOND) will respond to child distress by using "reciprocal activation" strategies to overcome normalization-the acceptance among parents and clinicians that symptom distress is an unavoidable outcome of serious illness-and integration of a specialty pediatric palliative care team (PPC). The overall objective of the study is to evaluate the feasibility of running a full-scale RCT that compares the effect of the PediQUEST ResPOND intervention vs. usual care in children and AYA with SNI.
Specific Aims are to 1. assess study's feasibility and acceptability by evaluating recruitment (rates and suitability of screening/tracking), adherence to the intervention (by study participants and interventionists), and retention (dropout rates, reasons, and demographics); and, 2. explore potential for intervention's efficacy by estimating effect sizes and variability of the outcomes proposed for the full-scale RCT (child recurrent pain and symptom burden, and parent outcomes) and assessing intervention's acceptability through semi-structured interviews.
Methods: Researchers will conduct a single site Phase II Pilot 2:1 RCT of PQ-ResPOND (intervention, n=30) vs. usual care (control, n=15) in 45 children ≥1 year-old \& AYA with SNI and moderate to severe recurrent pain behaviors. After randomization, participants will answer weekly PQ-ResPOND surveys and monthly outcome surveys over 12 weeks via the PQ App, and a semi-structured exit interview. Intervention: participants assigned to this arm will receive the PQ-ResPOND intervention which combines (i) parent-mediated activation through weekly collection and feedback to parents and clinicians, via our PQ App, of parent reported child pain (Non-Communicating Children's Pain Checklist-Revised scale (NCCPC-R)) and other symptoms (PediQUEST-Memorial Symptom Assessment Scale adapted for children with SNI), with (ii) PPC team-mediated activation of primary clinicians and parents: through PPC consultation, and (iii) PPC team activation through training in a standardized approach to recurrent pain using the PQ-ResPOND Checklist (adapted by the study's interprofessional expert panel). Usual care: participants in this arm will continue receiving care as usual.
Outcomes: Investigators will use quantitative and qualitative outcomes to study feasibility and acceptability including recruitment and retention rates, intermittent attrition, adherence to intervention delivery by clinicians, and participant and clinician's acceptability of the intervention. To preliminarily estimate effect sizes and variability, the corresponding scores for child's pain and symptom burden, and parent distress and activation measures will be estimated.
Analysis: For feasibility and acceptability quantitative outcomes investigators will use descriptive statistics. Demographics and reasons for attrition will be reported to explore potential for selection bias. A focused thematic analysis will be used to analyze qualitative variables. To estimate effect sizes and variability of trial outcomes, mixed linear regression models will be estimated. A predefined set of progression criteria are in place.
Discussion: Results will inform whether a full-scale Phase III RCT is warranted, and will help with study design and sample size calculation, development of a manual of procedures and fidelity monitoring strategies.
- Conditions
- Cerebral Palsy Infantile, Disabilities Multiple, Pain
- Being tested
- PediQUEST ResPOND
- Keywords
- Disabled children, pain, palliative care, electronic patient reported outcomes measures, Severe neurologic impairment
- Medical subject headings
- Cerebral Palsy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PediQUEST ResPONDBehavioural
Also called Intervention Arm
PPC teams will have access to feedback reports and the PQ-ResPOND checklist (standardized framework to diagnosis and treatment of recurrent pain behaviors in children with severe neurologic impairment).
Integration of the PPC team into care will be achieved through (i) initial consultation (goals: identify treatment goals, and address recurrent pain), and (ii) follow-up: the team will contact or visit the family in response to feedback reports or for treatment monitoring purposes.
| Study group | Role | What they receive |
|---|---|---|
| PQ-ResPOND (Intervention) | Experimental | 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. Receives: Behavioral: PediQUEST ResPOND |
| Usual care (Control) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Proportion of contacted potential participants meeting initial inclusion criteria who consent to participate
Measured: 16 months
Recruitment/month
Number of participants recruited per month
Measured: 16 months
Randomization rate
Proportion of enrolled participants who meet randomization criteria (moderate to severe pain)
Measured: 16 months
Suitability of screening/tracking
Qualitative outcome: As reported by research staff and site investigators involved in patient validation
Measured: 16 months
Sample diversity
Proportion of enrolled participants by race/ ethnicity
Measured: 16 months
Refusal reasons
Qualitative: Description of reasons for refusal mentioned in the consent conversation or non-participation survey
Measured: 16 months
Dropout rate
Proportion of enrolled participants who dropout from the study
Measured: 16 months
Demographics of dropouts
Proportion of dropout participants by race/ ethnicity
Measured: 16 months
Dropout reasons
Description of dropout reasons referred by participants during exit interview or dropout conversation
Measured: 16 months
Intermittent attrition
Surveys' response rates and distribution of non-responses will be used to determine participant's adherence with study data collection procedures
Measured: 16 months
Adherence with answering surveys
Qualitative: Parent perspectives on survey frequency, length, relevance, and burden
Measured: 16 months
Feasibility of intervention delivery
Qualitative: Using information from the PQ system, medical records, and exit interviews we will assess how feasible it is to deliver the different intervention components.
Measured: 16 months
Participant's acceptability of the intervention
Satisfaction with the intervention measured through a numerical 0-10 rating score
Measured: At week 12
Likelihood that participants would recommend study to others
Agreement with recommending the study to others using a numeric 0-10 rating score
Measured: At week 12
Participant's acceptability of intervention (qualitative)
Qualitative: We will explore participant's views on the intervention during exit interviews
Measured: At week 12
Clinician's acceptability of intervention (qualitative)
Qualitative: Clinicians views on the intervention will be explored during semi-structured clinician interviews (these will be conducted every 6 months with a subset of clinicians)
Measured: 16 months
Participant's overall satisfaction with the study
We will analyze participant's overall satisfaction with the study on a 0 to 10 numeric scale
Measured: At study exit
Secondary outcomes (14)
Child pain
This is the proposed primary outcome for future Phase III trial. All secondary outcomes will be used to preliminarily estimate effect sizes and help with sample size calculations. We will present estimates of effect, variability, and intraclass correlation coefficients with their 95% Confidence Intervals (95%CI).
Difference between intervention and control arms of the average Pediatric Pain Profile (PPP) most difficult day of last week scores over 12 weeks, measured monthly, as reported by the parent for all enrolled children. Score range: 0-60, higher scores indicate more pain. Cut off point for pain: 14 (>14 indicates pain)
Measured: 12 weeks
Child symptom burden
Difference between intervention and control arms of the average (PediQUEST ResPOND Memorial Symptom Assessment Scale, PQ-ResPOND MSAS) total scores over 12 weeks, as reported weekly by the parent. PQ-ResPOND MSAS total scores are calculated as the average of the 21 individual symptom scores. Individual symptom scores are calculated as the average of the three symptom questions. Individual symptom scores and total scores range from 0-100, 100 indicates higher symptom burden.
Measured: 12 weeks
Parent Anxiety
Difference between trial arms of the average Spielberger's-State Anxiety Inventory-State scores over 12 weeks, measured monthly. Scores range from 20 to 80, with higher scores correlating with greater anxiety.
Measured: 12 weeks
Parent Depression
Difference between trial arms of the mean Center for Epidemiologic Studies Short Depression Scale (CES-D-10) scores over 12 weeks. Scores range from 0 to 30 (Score of 10 or higher indicates the presence of significant depressive symptoms).
Measured: 12 weeks
Parent Pain-related Stress
Difference between trial arms of the mean pain-related stress scores measured with an adapted version of the stress-portion of the Response to Stress Questionnaire-Pain, measured monthly. The tool assesses 12 potential stress sources. Scores range from 1-4 (higher means more stress). Symptom-related stress score calculated as the sum of the 12 item scores.
Measured: 12 weeks
Parent overall health quality
Difference between trial arms of the mean overall health quality score measured monthly with one item of the Short Form (12) Health Survey (SF-12). Uses a 5 point Likert type scale and is scored 0-100, where 100 is excellent overall health.
Measured: 12 weeks
Parent sleep quality - total sleep time
Parent sleep quality will be measured with an adapted version of the Consensus Sleep Diary. Difference between trial arms of the mean overall score of the weekly average total sleep time (in hours), measured monthly. More hours of sleep is better.
Measured: 12 weeks
Parent sleep quality - refreshing sleep
Measured with an adapted version of the Consensus Sleep Diary. Difference between trial arms of the mean overall weekly score of the refreshing sleep item, measured monthly. Response options 1 to 5, where 5 is extremely refreshing.
Measured: 12 weeks
Use of Complementary Therapies
Difference between trial arms of the No. of complementary therapies used measured monthly with the Use of Complementary therapies checklist (developed ad hoc). Continuous variable, where higher numbers indicates more use of complementary therapies.
Measured: 12 weeks
Parent Coping - Active coping
Difference between trial arms of the mean overall active coping score measured monthly with the Short version of the Coping Orientation to Problems Experienced Inventory (Brief COPE).
Scores on each scale (or item) range from 2 to 8, with higher scores indicating greater use of that strategy.
Measured: 12 weeks
Parent Coping - Planning
Difference between trial arms of the mean planning coping score measured monthly with the Short version of the Coping Orientation to Problems Experienced Inventory (Brief COPE). Scores on each scale (or item) range from 2 to 8, with higher scores indicating greater use of that strategy.
Measured: 12 weeks
Parent Coping - Instrumental support
Difference between trial arms of the mean instrumental support coping score measured monthly with the Short version of the Coping Orientation to Problems Experienced Inventory (Brief COPE). Scores on each scale (or item) range from 2 to 8, with higher scores indicating greater use of that strategy.
Measured: 12 weeks
Parent Coping - Acceptance
Difference between trial arms of the mean acceptance coping score measured monthly with the Short version of the Coping Orientation to Problems Experienced Inventory (Brief COPE).
Scores on each scale (or item) range from 2 to 8, with higher scores indicating greater use of that strategy.
Measured: 12 weeks
Parent Coping - Self-blame
Difference between trial arms of the mean self-blame coping score measured monthly with the Short version of the Coping Orientation to Problems Experienced Inventory (Brief COPE). Scores on each scale (or item) range from 2 to 8, with higher scores indicating greater use of that strategy.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start8 May 2024
- Primary completion15 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy InfantileStudies of the same condition, open and under way.
- More trials run by Massachusetts General 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2:1 parallel RCT
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Boston Children's Hospital, Dana-Farber Cancer Institute, University of Alabama at Birmingham, Deakin University
- Responsible party
- Principal investigator, Joanne Wolfe, MD, MPH, Massachusetts General Hospital
- Investigators
- Joanne Wolfe, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075797
- Sponsor's protocol ID
- 2023p002305
- Other IDs
- 1R21NR020433
- Acronym
- PQ-ResPOND
- Status last verified
- Oct 2024
- First submitted
- 26 Sep 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of The PediQUEST Response to Pain Of Children With Neurologic Disability (PQ-ResPOND) Intervention: a Pilot Randomized Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT06075797
- Acronym / sponsor ID
- PQ-ResPOND / 2023p002305
- Conditions
- Cerebral Palsy Infantile, Disabilities Multiple, Pain
- Keywords
- Disabled children, pain, palliative care, electronic patient reported outcomes measures, Severe neurologic impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Boston Children's Hospital, Dana-Farber Cancer Institute, University of Alabama at Birmingham, Deakin University
- Study start
- 8 May 2024 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 10 Oct 2023 (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 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:
- 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.
Detailed description
Background: In the US, tens of thousands of children, adolescents, and young adults (AYA) are estimated to live with severe neurologic impairment (SNI). Over 60% of these children endure uncontrolled and often persistent pain, which frequently goes unrecognized and untreated. The impact extends to their parents who commonly experience unremitting physical and psychological distress. There has been a lack of rigorous studies that focus on interventions to alleviate recurrent pain in children with SNI. This gap might be attributed to the stigmatization of these children, who are often from historically marginalized backgrounds, resulting in a low prioritization in research endeavors. To address this inequity and using the ORBIT Model for intervention development, the investigators have adapted and are refining an intervention previously applied in children with cancer. The PediQUEST Response to Pain Of children with Neurologic Disability (PQ-ResPOND) will respond to child distress by using "reciprocal activation" strategies to overcome normalization-the acceptance among parents and clinicians that symptom distress is an unavoidable outcome of serious illness-and integration of a specialty pediatric palliative care team (PPC). The overall objective of the study is to evaluate the feasibility of running a full-scale RCT that compares the effect of the PediQUEST ResPOND intervention vs. usual care in children and AYA with SNI.
Specific Aims are to 1. assess study's feasibility and acceptability by evaluating recruitment (rates and suitability of screening/tracking), adherence to the intervention (by study participants and interventionists), and retention (dropout rates, reasons, and demographics); and, 2. explore potential for intervention's efficacy by estimating effect sizes and variability of the outcomes proposed for the full-scale RCT (child recurrent pain and symptom burden, and parent outcomes) and assessing intervention's acceptability through semi-structured interviews.
Methods: Researchers will conduct a single site Phase II Pilot 2:1 RCT of PQ-ResPOND (intervention, n=30) vs. usual care (control, n=15) in 45 children ≥1 year-old \& AYA with SNI and moderate to severe recurrent pain behaviors. After randomization, participants will answer weekly PQ-ResPOND surveys and monthly outcome surveys over 12 weeks via the PQ App, and a semi-structured exit interview. Intervention: participants assigned to this arm will receive the PQ-ResPOND intervention which combines (i) parent-mediated activation through weekly collection and feedback to parents and clinicians, via our PQ App, of parent reported child pain (Non-Communicating Children's Pain Checklist-Revised scale (NCCPC-R)) and other symptoms (PediQUEST-Memorial Symptom Assessment Scale adapted for children with SNI), with (ii) PPC team-mediated activation of primary clinicians and parents: through PPC consultation, and (iii) PPC team activation through training in a standardized approach to recurrent pain using the PQ-ResPOND Checklist (adapted by the study's interprofessional expert panel). Usual care: participants in this arm will continue receiving care as usual.
Outcomes: Investigators will use quantitative and qualitative outcomes to study feasibility and acceptability including recruitment and retention rates, intermittent attrition, adherence to intervention delivery by clinicians, and participant and clinician's acceptability of the intervention. To preliminarily estimate effect sizes and variability, the corresponding scores for child's pain and symptom burden, and parent distress and activation measures will be estimated.
Analysis: For feasibility and acceptability quantitative outcomes investigators will use descriptive statistics. Demographics and reasons for attrition will be reported to explore potential for selection bias. A focused thematic analysis will be used to analyze qualitative variables. To estimate effect sizes and variability of trial outcomes, mixed linear regression models will be estimated. A predefined set of progression criteria are in place.
Discussion: Results will inform whether a full-scale Phase III RCT is warranted, and will help with study design and sample size calculation, development of a manual of procedures and fidelity monitoring strategies.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2:1 parallel RCT
| Arm | Type | Receives |
|---|---|---|
| PQ-ResPOND (Intervention) | Experimental | Behavioral: PediQUEST ResPONDParticipants 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. |
| Usual care (Control) | No intervention | –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. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Parent-child dyads will be included based on the following criteria:
- ≥ 1 year old,
- receiving routine (ongoing) care at Boston Children's Hospital, AND
- followed by the Neurology, Cerebral Palsy or Complex Care services.
- has severe neurological impairment, defined as:
Key exclusion criteria (12 listed)
- Parent-child dyads will be excluded if any of the following apply:
- "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,
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 |
|---|---|---|
| PediQUEST ResPONDAlso: Intervention ArmPPC teams will have access to feedback reports and the PQ-ResPOND checklist (standardized framework to diagnosis and treatment of recurrent pain behaviors in children with severe neurologic impairment). Integration of the PPC team into care will be achieved through (i) initial consultation (goals: identify treatment goals, and address recurrent pain), and (ii) follow-up: the team will contact or visit the family in response to feedback reports or for treatment monitoring purposes. | Behavioural | PQ-ResPOND (Intervention) |
Primary outcome
Recruitment rate
Time frame: 16 months
Proportion of contacted potential participants meeting initial inclusion criteria who consent to participate
Recruitment/month
Time frame: 16 months
Number of participants recruited per month
Randomization rate
Time frame: 16 months
Proportion of enrolled participants who meet randomization criteria (moderate to severe pain)
Suitability of screening/tracking
Time frame: 16 months
Qualitative outcome: As reported by research staff and site investigators involved in patient validation
Sample diversity
Time frame: 16 months
Proportion of enrolled participants by race/ ethnicity
Refusal reasons
Time frame: 16 months
Qualitative: Description of reasons for refusal mentioned in the consent conversation or non-participation survey
Dropout rate
Time frame: 16 months
Proportion of enrolled participants who dropout from the study
Demographics of dropouts
Time frame: 16 months
Proportion of dropout participants by race/ ethnicity
Dropout reasons
Time frame: 16 months
Description of dropout reasons referred by participants during exit interview or dropout conversation
Intermittent attrition
Time frame: 16 months
Surveys' response rates and distribution of non-responses will be used to determine participant's adherence with study data collection procedures
Adherence with answering surveys
Time frame: 16 months
Qualitative: Parent perspectives on survey frequency, length, relevance, and burden
Feasibility of intervention delivery
Time frame: 16 months
Qualitative: Using information from the PQ system, medical records, and exit interviews we will assess how feasible it is to deliver the different intervention components.
Participant's acceptability of the intervention
Time frame: At week 12
Satisfaction with the intervention measured through a numerical 0-10 rating score
Likelihood that participants would recommend study to others
Time frame: At week 12
Agreement with recommending the study to others using a numeric 0-10 rating score
Participant's acceptability of intervention (qualitative)
Time frame: At week 12
Qualitative: We will explore participant's views on the intervention during exit interviews
Clinician's acceptability of intervention (qualitative)
Time frame: 16 months
Qualitative: Clinicians views on the intervention will be explored during semi-structured clinician interviews (these will be conducted every 6 months with a subset of clinicians)
Participant's overall satisfaction with the study
Time frame: At study exit
We will analyze participant's overall satisfaction with the study on a 0 to 10 numeric scale
14 secondary outcomes
Child pain
Time frame: 12 weeks
Child symptom burden
Time frame: 12 weeks
Parent Anxiety
Time frame: 12 weeks
Parent Depression
Time frame: 12 weeks
Parent Pain-related Stress
Time frame: 12 weeks
Parent overall health quality
Time frame: 12 weeks
Parent sleep quality - total sleep time
Time frame: 12 weeks
Parent sleep quality - refreshing sleep
Time frame: 12 weeks
Use of Complementary Therapies
Time frame: 12 weeks
Parent Coping - Active coping
Time frame: 12 weeks
Parent Coping - Planning
Time frame: 12 weeks
Parent Coping - Instrumental support
Time frame: 12 weeks
Parent Coping - Acceptance
Time frame: 12 weeks
Parent Coping - Self-blame
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy Infantile
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
RecruitingObservational study
Study of Sagittal Pelvic Statics in the Sitting Position in Children With Cerebral Palsy
Cerebral Palsy Infantile
Not yet recruiting
Using Power Mobility Training to Promote Arm & Hand Function in Children With Cerebral Palsy
Cerebral Palsy, Hemiplegia, Infantile
Not yet recruiting
Coaching, Learning, Empowerment in Cerebral Palsy - a 6-Week Integrated PT/OT Caregiver "Primer" Bootcamp for Infants Diagnosed With or at High Risk for Cerebral Palsy
Cerebral Palsy, Cerebral Palsy (CP)
RecruitingObservational study
Motor-voice Assessment in Infants (MAMI)
Cerebral Palsy Infantile, Pre-Term
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. This study is not recruiting at the moment.
Joanne Wolfe, MD, MPH principal investigator
Massachusetts General Hospital
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PediQUEST ResPOND in people with Cerebral Palsy Infantile and Disabilities Multiple, run by Massachusetts General Hospital at 4 sites in 2 countries.
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 10 inclusion and 12 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: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 16 months). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2026.