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Ready for Change: Enhancing Motivational Engagement Prior to IIPT

Ready for Change: a Telehealth, Motivational Enhancement Pre-habilitation Training to Increase Engagement in Children and Families Entering Intensive Interdisciplinary Pain Rehabilitation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04093921
Acronym
PREPaRe
Enrollment
78
Registered
2019-09-18
Start date
2020-06-15
Completion date
2023-12-10
Last updated
2025-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

chronic pain, pediatric

Brief 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.

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.

Interventions

BEHAVIORALMET-based therapy

see previous

BEHAVIORALStandard Care

To include all recommended outpatient treatments

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Masking description

Those providing care at the PPRC will not know which study arm their patients were in.

Eligibility

Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Non-English speaking * No access to device with telehealth capability

Design outcomes

Primary

MeasureTime frameDescription
Readiness RulersDuring and at end of the intervention, for the treatment group onlyMotivational interviewing based ratings of willingness, importance, awareness and confidence related to adopting a self-management approach to pain
Length of stayPPRC discharge [within 6 months of baseline]length of stay in PPRC program (in weeks)
Functional disability inventory (FDI) total scoreat 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)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.
Modified Adolescent Treatment Engagement QuestionnaireAt end of intervention, 4 weeks from baselineLevel of engagement in treatment. Scores 0-40 higher scores indicate more engagement.
Chronic Pain Acceptance Questionnaire total scoreAt 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.
Treatment satisfaction inventoryAt end of intervention, 4 weeks from baselineParticipant satisfaction with treatment. 13 items range 13-65, higher scores = more satisfaction

Secondary

MeasureTime frameDescription
Pain intensityAt PPRC admission (4-6 weeks post baseline)pain intensity on 0-10 numeric scale (10=worst pain)
Functional disability inventory (FDI) total scoreat PPRC discharge [within 6 months of baseline]level of pain related functional disability, ranges from 0-60 with higher scores indicating more disability
Committed action questionnaire total scoreAt PPRC admission [typically within 3 months of baseline]Secondary measure of readiness to change/engage in pain self-management. 8 item questionnaire with range 0-48. Higher scores indicate more committed action.
Committed action questionnaireAt PPRC discharge [within 6 months of baseline]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.
Parental pain catastrophizingAt treatment admission and discharge, following intervention/control periodMeasure of parents' negative thoughts related to child's pain
Adult responses to child pain - protect subscaleAt treatment admission and discharge, following intervention/control periodParental protective responses to child pain behaviors
Parental fear of pain questionnaireAt treatment admission and discharge, following intervention/control periodParent report of pain related fears/worries

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026