Ready for Change: Enhancing Motivational Engagement Prior to IIPT (PREPaRe)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: MET-based therapy; Behavioral: Standard Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; see previous; Behavioral: Standard Care; To include all recommended outpatient treatments
Active Comparator: Standard Care; Participate in all recommended outpatient pain treatments while awaiting PPRC admission.	Behavioral: Standard Care; To include all recommended outpatient treatments

What is the study measuring?

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]

Collaborators and Investigators

• Sponsor: Boston Children's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2020
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: September 10, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (Actual): September 18, 2019

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: chronic pain; pediatric
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: P00033150

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a pilot study and we do not think the data should be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No