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Completed

NCT Number: NCT04093921

Ready for Change: Enhancing Motivational Engagement Prior to IIPT

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MET-based therapy

Behavioral

see previous

Standard Care

Behavioral

To include all recommended outpatient treatments

Primary outcomes

  1. Length of stay

    Time frame: PPRC discharge [within 6 months of baseline]

    length of stay in PPRC program (in weeks)

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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

Secondary outcomes

  1. Pain intensity

    Time frame: At PPRC admission (4-6 weeks post baseline)

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

  2. Pain intensity

    Time frame: At PPRC discharge [within 6 months of baseline]

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

  3. Functional disability inventory (FDI) total score

    Time frame: at PPRC discharge [within 6 months of baseline]

    level of pain related functional disability, ranges from 0-60 with higher scores indicating more disability

  4. Functional disability inventory (FDI) total score

    Time frame: at PPRC follow up (1 year post discharge)

    level of pain related functional disability, ranges from 0-60 with higher scores indicating more disability

  5. Pain intensity

    Time frame: At first post-treatment follow up (4-8 weeks post discharge)

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

  6. Pain intensity

    Time frame: 1 year post-treatment

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

  7. Committed action questionnaire total score

    Time frame: At 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.

  8. Committed action questionnaire

    Time frame: At 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.

  9. Parental pain catastrophizing

    Time frame: At treatment admission and discharge, following intervention/control period

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

  10. Adult responses to child pain - protect subscale

    Time frame: At treatment admission and discharge, following intervention/control period

    Parental protective responses to child pain behaviors

  11. Parental fear of pain questionnaire

    Time frame: At treatment admission and discharge, following intervention/control period

    Parent report of pain related fears/worries

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

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

Acronym: PREPaRe

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 18, 2019
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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