Chronic PainPREPaReNCT04093921
Ready for Change: Enhancing Motivational Engagement Prior to IIPT
A study testing MET-based therapy in people with Chronic Pain, run by Boston Children's Hospital at 1 site in United States.
Trial summary
This is a randomized, motivational-interviewing-based intervention to improve readiness-to-change, or willingness to engage in a self-management approach to chronic pain, for patients referred to our intensive interdisciplinary pain rehabilitation day program. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- MET-based therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2020to 10 Dec 2023
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient age 8-18 at enrollment
- Presence of chronic pain condition for > 3 months with moderate or severe disability
- Accepts referral to PPRC and awaiting admission
Who cannot join
- Non-English speaking
- No access to device with telehealth capability
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Ready for Change: a Telehealth, Motivational Enhancement Pre-habilitation Training to Increase Engagement in Children and Families Entering Intensive Interdisciplinary Pain Rehabilitation
This is a randomized, motivational-interviewing-based intervention to improve readiness-to-change, or willingness to engage in a self-management approach to chronic pain, for patients referred to our intensive interdisciplinary pain rehabilitation day program.
Read the detailed description
Readiness to change, or willingness to engage in a self-management approach to chronic pain and disability, is the most powerful predictor of children's success in intensive pediatric pain rehabilitation. Motivational Enhancement Therapy (MET) is an approach that has been effective in increasing readiness to change and treatment engagement for other behaviorally-oriented health interventions. However, MET has never been systemically employed in the context of treating pediatric chronic pain and disability.
This demonstration project seeks to test the effects of a novel telehealth intervention using motivation enhancement therapy to improve patient and parent engagement in, and outcomes of, an intensive interdisciplinary day hospital program for children with complex chronic pain conditions and associated disability, the Pediatric Pain Rehabilitation Center (PPRC). The intervention, PPRC-Prep, is a 4 week MET-based telehealth intervention that will be offered to families of children with refractory chronic pain conditions awaiting admission to the PPRC at Boston Children's Hospital at Waltham. Families approved for and awaiting PPRC admission will be randomized to receive PPRC-Prep along with usual care or to a comparison group receiving treatment as usual. Study aims include assessing the feasibility and acceptability of the intervention along with measuring its potential to increase readiness to engage in a self-management approach assessed at time of admission to the PPRC using established measures of readiness to change, pain acceptance, and committed action. Investigators will also evaluate the effects of PPRC-Prep on program length of stay and on reductions of disability and pain at PPRC discharge and short-term (8-week) follow up through comparison of families who undergo PPRC-prep with families who do not undergo PPRC-prep. Demonstrating the feasibility and preliminary effectiveness of PPRC-Prep will enable the study team to establish this as a routine component of our approach to care for children with complex, refractory chronic pain and disability.
- Conditions
- Chronic Pain
- Being tested
- MET-based therapy, Standard Care
- Keywords
- chronic pain, pediatric
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MET-based therapyBehavioural
see previous
Standard CareBehavioural
To include all recommended outpatient treatments
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Receive motivational enhancement training based, telehealth-delivered 6-8 session intervention aimed at increasing readiness to engage in pain self-management, in addition to all recommended outpatient treatments. Receives: Behavioral: MET-based therapy; Behavioral: Standard Care |
| Standard Care | Active comparator | Participate in all recommended outpatient pain treatments while awaiting PPRC admission. Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
length of stay in PPRC program (in weeks)
Measured: PPRC discharge [within 6 months of baseline]
Functional disability inventory (FDI) total score
level of pain related functional disability, ranges from 0-60 with higher scores indicating more disability
Measured: at PPRC follow up (4-8 weeks post discharge)
Pain stages of change questionnaire for adolescents (PSOCQ-A)
readiness to change/embrace pain self-management. 13 item scale with total scores ranging from 13-65. Domain with highest score is considered current stage of change.
Measured: PPRC admission (within 2 months of baseline)
Pain stages of change questionnaire for adolescents (PSOCQ-A)
readiness to change/embrace pain self-management. 13 item scale with total scores ranging from 13-65. Domain with highest score is considered current stage of change.
Measured: PPRC discharge [within 6 months of baseline]
Pain stages of change questionnaire for adolescents (PSOCQ-A)
readiness to change/embrace pain self-management. 13 item scale with total scores ranging from 13-65. Domain with highest score is considered current stage of change.
Measured: at PPRC follow up (4-8 weeks post discharge)
Pain stages of change questionnaire for adolescents (PSOCQ-A)
readiness to change/embrace pain self-management. 13 item scale with total scores ranging from 13-65. Domain with highest score is considered current stage of change.
Measured: at PPRC follow up (1 year post discharge)
Modified Adolescent Treatment Engagement Questionnaire
Level of engagement in treatment. Scores 0-40 higher scores indicate more engagement.
Measured: At end of intervention, 4 weeks from baseline
Chronic Pain Acceptance Questionnaire total score
Measure of readiness to change/engage in pain self-management. 20 item questionnaire, will use total score. Range 0-120. HIgher scores indicate more pain acceptance.
Measured: At PPRC discharge [within 6 months of baseline]
Chronic Pain Acceptance Questionnaire total score
Measure of readiness to change/engage in pain self-management. 20 item questionnaire, will use total score. Range 0-120. HIgher scores indicate more pain acceptance.
Measured: At PPRC admission [typically within 3 months of baseline]
Treatment satisfaction inventory
Participant satisfaction with treatment. 13 items range 13-65, higher scores = more satisfaction
Measured: At end of intervention, 4 weeks from baseline
Readiness Rulers
Motivational interviewing based ratings of willingness, importance, awareness and confidence related to adopting a self-management approach to pain
Measured: During and at end of the intervention, for the treatment group only
Secondary outcomes (11)
Pain intensity
pain intensity on 0-10 numeric scale (10=worst pain)
Measured: At PPRC admission (4-6 weeks post baseline)
Pain intensity
pain intensity on 0-10 numeric scale (10=worst pain)
Measured: At PPRC discharge [within 6 months of baseline]
Functional disability inventory (FDI) total score
level of pain related functional disability, ranges from 0-60 with higher scores indicating more disability
Measured: at PPRC discharge [within 6 months of baseline]
Functional disability inventory (FDI) total score
level of pain related functional disability, ranges from 0-60 with higher scores indicating more disability
Measured: at PPRC follow up (1 year post discharge)
Pain intensity
pain intensity on 0-10 numeric scale (10=worst pain)
Measured: At first post-treatment follow up (4-8 weeks post discharge)
Pain intensity
pain intensity on 0-10 numeric scale (10=worst pain)
Measured: 1 year post-treatment
Committed action questionnaire total score
Secondary measure of readiness to change/engage in pain self-management. 8 item questionnaire with range 0-48. Higher scores indicate more committed action.
Measured: At PPRC admission [typically within 3 months of baseline]
Committed action questionnaire
Secondary measure of readiness to change/engage in pain self-management. 8 item questionnaire with range 0-48. Higher scores indicate more committed action/readiness.
Measured: At PPRC discharge [within 6 months of baseline]
Parental pain catastrophizing
Measure of parents' negative thoughts related to child's pain
Measured: At treatment admission and discharge, following intervention/control period
Adult responses to child pain - protect subscale
Parental protective responses to child pain behaviors
Measured: At treatment admission and discharge, following intervention/control period
Parental fear of pain questionnaire
Parent report of pain related fears/worries
Measured: At treatment admission and discharge, following intervention/control period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start15 Jun 2020
- Primary completion1 Dec 2023
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Boston Children's 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deirdre Logan, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093921
- Sponsor's protocol ID
- P00033150
- Acronym
- PREPaRe
- Status last verified
- Jan 2025
- First submitted
- 10 Sep 2019
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: THis is a very small, early phase RCT. There may be specific circumstances in which it would be appropriate to share our data. We welcome contact from investigators in the area of pediatric pain and would work to determine best sharing practices if relevant. All data would be de-identified.
Publications
Smith AM, Logan DE. Promoting readiness and engagement in pain rehabilitation for youth and families: Developing a pediatric telehealth motivational interviewing protocol. Paediatr Neonatal Pain. 2021 Oct 28;4(3):125-135. doi: 10.1002/pne2.12063. eCollection 2022 Sep.
PubMed 36188162
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ready for Change: a Telehealth, Motivational Enhancement Pre-habilitation Training to Increase Engagement in Children and Families Entering Intensive Interdisciplinary Pain Rehabilitation
- ClinicalTrials.gov ID
- NCT04093921
- Acronym / sponsor ID
- PREPaRe / P00033150
- Conditions
- Chronic Pain
- Keywords
- chronic pain, pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 18 Sep 2019 (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.
This is a randomized, motivational-interviewing-based intervention to improve readiness-to-change, or willingness to engage in a self-management approach to chronic pain, for patients referred to our intensive interdisciplinary pain rehabilitation day program.
Detailed description
Readiness to change, or willingness to engage in a self-management approach to chronic pain and disability, is the most powerful predictor of children's success in intensive pediatric pain rehabilitation. Motivational Enhancement Therapy (MET) is an approach that has been effective in increasing readiness to change and treatment engagement for other behaviorally-oriented health interventions. However, MET has never been systemically employed in the context of treating pediatric chronic pain and disability.
This demonstration project seeks to test the effects of a novel telehealth intervention using motivation enhancement therapy to improve patient and parent engagement in, and outcomes of, an intensive interdisciplinary day hospital program for children with complex chronic pain conditions and associated disability, the Pediatric Pain Rehabilitation Center (PPRC). The intervention, PPRC-Prep, is a 4 week MET-based telehealth intervention that will be offered to families of children with refractory chronic pain conditions awaiting admission to the PPRC at Boston Children's Hospital at Waltham. Families approved for and awaiting PPRC admission will be randomized to receive PPRC-Prep along with usual care or to a comparison group receiving treatment as usual. Study aims include assessing the feasibility and acceptability of the intervention along with measuring its potential to increase readiness to engage in a self-management approach assessed at time of admission to the PPRC using established measures of readiness to change, pain acceptance, and committed action. Investigators will also evaluate the effects of PPRC-Prep on program length of stay and on reductions of disability and pain at PPRC discharge and short-term (8-week) follow up through comparison of families who undergo PPRC-prep with families who do not undergo PPRC-prep. Demonstrating the feasibility and preliminary effectiveness of PPRC-Prep will enable the study team to establish this as a routine component of our approach to care for children with complex, refractory chronic pain and disability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: MET-based therapy, Behavioral: Standard CareReceive motivational enhancement training based, telehealth-delivered 6-8 session intervention aimed at increasing readiness to engage in pain self-management, in addition to all recommended outpatient treatments. |
| Standard Care | Active comparator | Behavioral: Standard CareParticipate in all recommended outpatient pain treatments while awaiting PPRC admission. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patient age 8-18 at enrollment
- Presence of chronic pain condition for > 3 months with moderate or severe disability
- Accepts referral to PPRC and awaiting admission
Key exclusion criteria (2 listed)
- Non-English speaking
- No access to device with telehealth capability
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 |
|---|---|---|
| MET-based therapysee previous | Behavioural | Intervention |
| Standard CareTo include all recommended outpatient treatments | Behavioural | Intervention, Standard Care |
Primary outcome
Length of stay
Time frame: PPRC discharge [within 6 months of baseline]
length of stay in PPRC program (in weeks)
Functional disability inventory (FDI) total score
Time frame: at PPRC follow up (4-8 weeks post discharge)
level of pain related functional disability, ranges from 0-60 with higher scores indicating more disability
Pain stages of change questionnaire for adolescents (PSOCQ-A)
Time frame: PPRC admission (within 2 months of baseline)
readiness to change/embrace pain self-management. 13 item scale with total scores ranging from 13-65. Domain with highest score is considered current stage of change.
Pain stages of change questionnaire for adolescents (PSOCQ-A)
Time frame: PPRC discharge [within 6 months of baseline]
readiness to change/embrace pain self-management. 13 item scale with total scores ranging from 13-65. Domain with highest score is considered current stage of change.
Pain stages of change questionnaire for adolescents (PSOCQ-A)
Time frame: at PPRC follow up (4-8 weeks post discharge)
readiness to change/embrace pain self-management. 13 item scale with total scores ranging from 13-65. Domain with highest score is considered current stage of change.
Pain stages of change questionnaire for adolescents (PSOCQ-A)
Time frame: at PPRC follow up (1 year post discharge)
readiness to change/embrace pain self-management. 13 item scale with total scores ranging from 13-65. Domain with highest score is considered current stage of change.
Modified Adolescent Treatment Engagement Questionnaire
Time frame: At end of intervention, 4 weeks from baseline
Level of engagement in treatment. Scores 0-40 higher scores indicate more engagement.
Chronic Pain Acceptance Questionnaire total score
Time frame: At PPRC discharge [within 6 months of baseline]
Measure of readiness to change/engage in pain self-management. 20 item questionnaire, will use total score. Range 0-120. HIgher scores indicate more pain acceptance.
Chronic Pain Acceptance Questionnaire total score
Time frame: At PPRC admission [typically within 3 months of baseline]
Measure of readiness to change/engage in pain self-management. 20 item questionnaire, will use total score. Range 0-120. HIgher scores indicate more pain acceptance.
Treatment satisfaction inventory
Time frame: At end of intervention, 4 weeks from baseline
Participant satisfaction with treatment. 13 items range 13-65, higher scores = more satisfaction
Readiness Rulers
Time frame: During and at end of the intervention, for the treatment group only
Motivational interviewing based ratings of willingness, importance, awareness and confidence related to adopting a self-management approach to pain
11 secondary outcomes
Pain intensity
Time frame: At PPRC admission (4-6 weeks post baseline)
Pain intensity
Time frame: At PPRC discharge [within 6 months of baseline]
Functional disability inventory (FDI) total score
Time frame: at PPRC discharge [within 6 months of baseline]
Functional disability inventory (FDI) total score
Time frame: at PPRC follow up (1 year post discharge)
Pain intensity
Time frame: At first post-treatment follow up (4-8 weeks post discharge)
Pain intensity
Time frame: 1 year post-treatment
Committed action questionnaire total score
Time frame: At PPRC admission [typically within 3 months of baseline]
Committed action questionnaire
Time frame: At PPRC discharge [within 6 months of baseline]
Parental pain catastrophizing
Time frame: At treatment admission and discharge, following intervention/control period
Adult responses to child pain - protect subscale
Time frame: At treatment admission and discharge, following intervention/control period
Parental fear of pain questionnaire
Time frame: At treatment admission and discharge, following intervention/control period
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 4 Feb 2025.
- Derived from this study: PubMed 36188162Smith AM, Logan DE. Promoting readiness and engagement in pain rehabilitation for youth and families: Developing a pediatric telehealth motivational interviewing protocol. Paediatr Neonatal Pain. 2021 Oct 28;4(3):125-135. doi: 10.1002/pne2.12063. eCollection 2022 Sep.
- Individual participant dataSharing planned: Undecided. THis is a very small, early phase RCT. There may be specific circumstances in which it would be appropriate to share our data. We welcome contact from investigators in the area of pediatric pain and would work to determine best sharing practices if relevant. All data would be de-identified.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MET-based therapy in people with Chronic Pain, run by Boston Children's Hospital 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 3 inclusion and 2 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 4 Feb 2025. 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?
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?
Length of stay (time frame: PPRC discharge [within 6 months of baseline]). The study lists 11 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 NCT04093921, which also lists 1 linked publication.
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 4 Feb 2025.