Clinical trial NCT04093921: Ready for Change: Enhancing Motivational Engagement Prior to IIPT
Official title: Ready for Change: a Telehealth, Motivational Enhancement Pre-habilitation Training to Increase Engagement in Children and Families Entering Intensive Interdisciplinary Pain Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: chronic pain
pediatric
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2019-09-18
Enrollment: 78
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of stay
timeFrame: PPRC discharge [within 6 months of baseline]
measure: Functional disability inventory (FDI) total score
timeFrame: at PPRC follow up (4-8 weeks post discharge)
measure: Pain stages of change questionnaire for adolescents (PSOCQ-A)
timeFrame: PPRC admission (within 2 months of baseline)
measure: Pain stages of change questionnaire for adolescents (PSOCQ-A)
timeFrame: PPRC discharge [within 6 months of baseline]
measure: Pain stages of change questionnaire for adolescents (PSOCQ-A)
timeFrame: at PPRC follow up (4-8 weeks post discharge)
measure: Pain stages of change questionnaire for adolescents (PSOCQ-A)
timeFrame: at PPRC follow up (1 year post discharge)
measure: Modified Adolescent Treatment Engagement Questionnaire
timeFrame: At end of intervention, 4 weeks from baseline
measure: Chronic Pain Acceptance Questionnaire total score
timeFrame: At PPRC discharge [within 6 months of baseline]
measure: Chronic Pain Acceptance Questionnaire total score
timeFrame: At PPRC admission [typically within 3 months of baseline]
measure: Treatment satisfaction inventory
timeFrame: At end of intervention, 4 weeks from baseline
measure: Readiness Rulers
timeFrame: During and at end of the intervention, for the treatment group only
Secondary outcomes:
measure: Pain intensity
timeFrame: At PPRC admission (4-6 weeks post baseline)
measure: Pain intensity
timeFrame: At PPRC discharge [within 6 months of baseline]
measure: Functional disability inventory (FDI) total score
timeFrame: at PPRC discharge [within 6 months of baseline]
measure: Functional disability inventory (FDI) total score
timeFrame: at PPRC follow up (1 year post discharge)
measure: Pain intensity
timeFrame: At first post-treatment follow up (4-8 weeks post discharge)
measure: Pain intensity
timeFrame: 1 year post-treatment
measure: Committed action questionnaire total score
timeFrame: At PPRC admission [typically within 3 months of baseline]
measure: Committed action questionnaire
timeFrame: At PPRC discharge [within 6 months of baseline]
measure: Parental pain catastrophizing
timeFrame: At treatment admission and discharge, following intervention/control period
measure: Adult responses to child pain - protect subscale
timeFrame: At treatment admission and discharge, following intervention/control period
measure: Parental fear of pain questionnaire
timeFrame: At treatment admission and discharge, following intervention/control period
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References:
citation: 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.