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Ready for Change: Enhancing Motivational Engagement Prior to IIPT

Not Applicable
Completed
Conditions
Chronic Pain
Interventions
Behavioral: MET-based therapy
Behavioral: Standard Care
Registration Number
NCT04093921
Lead Sponsor
Boston Children's Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
78
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
InterventionStandard 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.
InterventionMET-based therapyReceive 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 CareStandard CareParticipate in all recommended outpatient pain treatments while awaiting PPRC admission.
Primary Outcome Measures
NameTimeMethod
Length of stayPPRC discharge [within 6 months of baseline]

length of stay in PPRC program (in weeks)

Pain stages of change questionnaire for adolescents (PSOCQ-A)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.

Chronic Pain Acceptance Questionnaire total scoreAt 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.

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

Readiness RulersDuring 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

Modified Adolescent Treatment Engagement QuestionnaireAt end of intervention, 4 weeks from baseline

Level of engagement in treatment. Scores 0-40 higher scores indicate more engagement.

Treatment satisfaction inventoryAt end of intervention, 4 weeks from baseline

Participant satisfaction with treatment. 13 items range 13-65, higher scores = more satisfaction

Secondary Outcome Measures
NameTimeMethod
Pain intensity1 year post-treatment

pain intensity on 0-10 numeric scale (10=worst pain)

Functional disability inventory (FDI) total scoreat PPRC follow up (1 year post discharge)

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 period

Measure of parents' negative thoughts related to child's pain

Adult responses to child pain - protect subscaleAt treatment admission and discharge, following intervention/control period

Parental protective responses to child pain behaviors

Parental fear of pain questionnaireAt treatment admission and discharge, following intervention/control period

Parent report of pain related fears/worries

Trial Locations

Locations (1)

Boston Children's Hospital

🇺🇸

Boston, Massachusetts, United States

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