Ready for Change: Enhancing Motivational Engagement Prior to IIPT

Chronic Pain Clinical Trial

— PREPaRe  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04093921
• Other study ID #: P00033150
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 15, 2020
• Est. completion date: December 2023

Study information

• Verified date: October 2023
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• MET-based therapy
see previous
• Standard Care
To include all recommended outpatient treatments

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay	length of stay in PPRC program (in days)	PPRC discharge [within 6 months of baseline]
Primary	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]
Primary	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)
Primary	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)
Primary	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)
Primary	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]
Primary	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)
Primary	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)
Primary	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
Primary	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	Pain intensity	pain intensity on 0-10 numeric scale (10=worst pain)	At PPRC admission (4-6 weeks post baseline)
Secondary	Pain intensity	pain intensity on 0-10 numeric scale (10=worst pain)	At PPRC discharge [within 6 months of baseline]
Secondary	Pain intensity	pain intensity on 0-10 numeric scale (10=worst pain)	At first post-treatment follow up (4-8 weeks post discharge)
Secondary	Pain intensity	pain intensity on 0-10 numeric scale (10=worst pain)	1 year post-treatment
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]