Ready for Change: Enhancing Motivational Engagement Prior to IIPT

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: MET-based therapy
* Behavioral: Standard Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Behavioral: MET-based therapy<br>* see previous<br>Behavioral: Standard Care<br>* To include all recommended outpatient treatments<br>|
| Active Comparator: Standard Care<br>Participate in all recommended outpatient pain treatments while awaiting PPRC admission. | Behavioral: Standard Care<br>* To include all recommended outpatient treatments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | length of stay in PPRC program (in days) | 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 | 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 | at PPRC follow up (4-8 weeks post discharge) | 
| Functional disability inventory (FDI) total score | level of pain related functional disability, ranges from 0-60 with higher scores indicating more disability | at PPRC follow up (1 year 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. | 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. | 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. | 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. | 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. | At end of intervention, 4 weeks from baseline | 
| Treatment satisfaction inventory | Participant satisfaction with treatment. 13 items range 13-65, higher scores = more satisfaction | At end of intervention, 4 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | pain intensity on 0-10 numeric scale (10=worst pain) | At PPRC admission (4-6 weeks post baseline) | 
| Pain intensity | pain intensity on 0-10 numeric scale (10=worst pain) | At PPRC discharge [within 6 months of baseline] | 
| Pain intensity | pain intensity on 0-10 numeric scale (10=worst pain) | At first post-treatment follow up (4-8 weeks post discharge) | 
| Pain intensity | pain intensity on 0-10 numeric scale (10=worst pain) | 1 year post-treatment | 
| Chronic Pain Acceptance Questionnaire total score | Secondary 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. | At PPRC admission [typically within 3 months of baseline] | 
| Chronic Pain Acceptance Questionnaire total score | Secondary 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. | At PPRC discharge [within 6 months of baseline] | 
| 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. | 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. | At PPRC discharge [within 6 months of baseline] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic pain, pediatric