CBT Program for Pain Management for Children and Youth With CP (CBT=Cognitive Behavioral Therapy; CP= Cerebral Palsy)

NCT04174326 | Unknown

• 1 other identifier: REB19-850
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This study will focus on the feasibility of a modified cognitive behavioral program for pain management among children and youth with cerebral palsy (CP) on developing pain coping skills and reducing pain interference levels The study design is a randomized control feasibility trial. Participants will be placed randomly into one of two groups based on chance (50/50). The 2 groups are: (1) immediate treatment group and (2) delayed wait-list treatment group. Both groups will receive the same intervention protocol.

Conditions

Cerebral Palsy; Chronic Pain

Keywords

Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (5)

• Pediatric Pain Interference Scale [PPIS]

  The Pediatric Pain Interference Scale (PPIS) was developed by the National Institutes of Health Patient Reported Outcomes Measurement Information System (PROMIS) initiative. The scale assesses pain-related behaviors across 5 domains (pain, fatigue, physical functioning, social health, and emotional health) and has been validated with pediatric populations (5-18 years) representing a variety of chronic health conditions, including CP. Scores vary from 8 to 40 with higher scores indicating higher level of pain interference. Decrease in levels of pain interference is considered a better outcome.

  Changes in PPIS from baseline to 6 and 18 weeks

• Proportion of eligible participants that are recruited as study participants during the study timeline [Feasibility]

  Participants must meet all eligibility criteria in order to be included in the analysis of this outcome measure. A higher proportion of eligible patients recruited is considered to be a better outcome.

  18 weeks

• Proportion of recruited participants that attend in 80% of the 6 study sessions during the intervention phase [Feasibility]

  Number of sessions participants engage in during the intervention phase vs. total number of sessions in the program. Participants must attend at least 5 of 6 sessions to reach 80% adherence to CBT sessions. Higher participation rate in therapy is considered to be a better outcome.

  18 weeks

• Proportion of recruited participants that completed 80% of the in-between session assignments during the intervention phase [Feasibility].

  Adherence to in-between sessions assignments score will be calculated based on number of assignments completed vs. anticipated compliance during the intervention phase (a total of 12 assignments). Higher adherence to complete in-between session assignments during therapy is considered to be a better outcome.

  18 weeks

• Proportion of recruited participants that attended the follow-up session 18 weeks from baseline [Feasibility].

  Adherence to participate in the follow-up session following the completion of the treatment. Higher adherence to participate in follow-up sessions is considered to be a better outcome.

  18 weeks

Secondary Outcomes (5)

• The Faces Pain Scale-Revised [FPS-R]

  Changes in pain intensity from baseline to 6 and 18 weeks

• Psychological Inflexibility in Pain Scale [PIPS]

  Changes in pain coping from baseline to 6 and 18 weeks

• KIDSCREEN-27 Health related quality of life [HRQoL]

  Changes in HRQoL from baseline to 18 weeks

• Pain Stages of Change Questionnaire-Parents [PSOCQ-P]

  Changes in PSOCQ-P from baseline to 18 6 and weeks

• Chronic Pain Acceptance Questionnaire-Parent [CPAQ-P]

  Changes in CPAQ-P from baseline to 6 and 18 weeks

Other Outcomes (2)

• Canadian Occupational Performance Measure [COPM]

  Changes in COPM from baseline to 18 weeks

• Pediatric Rehabilitation Intervention Measure of Engagement - Service Provider [PRIME-SP]

  Change in engagement in intervention session from baseline to 18 weeks.

Study Arms (2)

Intervention group

EXPERIMENTAL

A weekly 2 hour CBT for chronic pain group intervention for a duration of 6 weeks

Behavioral: Immediate intervention group

Delayed intervention group

NO INTERVENTION

A waiting list for CBT for chronic pain group intervention.

Interventions

Immediate intervention group BEHAVIORAL

Participants will be randomized to either the immediate or delayed intervention group at baseline. Participants in both groups will receive CBT for chronic pain management sequentially, once a week during the 6 week intervention period. Participants will be followed-up at 18 weeks from baseline. Two in-between sessions practice assignments will be added to each group therapy session during the the CBT program.

Also known as: Immediate

Intervention group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of CP
• Chronic pain lasting greater than 3 months and restricting some or all activities according to child/youth/parental self-report
• A baseline score of 70 (\~ -2 SD) on each of the three vineland adaptive behavior scales (VABS) sub-scales: communication, daily living skills and socialization
• Successful completion of a modified sorting task including sorting cubes according to size and rating activities in order of how much they like to do them
• Parent agreement to participate in the parents' program
• Can communicate in English, with or without the use of augmentative communication devices

You may not qualify if:

• Participants who meet any of the following criteria will not be eligible to take part in the trial:
• Diagnosis of major visual or hearing impairment
• Currently attending psychological treatment focused on pain management; (3) Uncontrolled seizure(s) (with or without medication) in the previous 12 months.

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead

Study Sites (1)

Holland-Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Cerebral Palsy; Chronic Pain

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Darcy Fehlings, MD, MSc

  Holland Bloorview Kids Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to either immediate treatment group or delayed waitlist treatment group at baseline. Participants in both groups will receive the same CBT intervention program consecutively, once a week during a period of 6 weeks. Two in-between sessions practice assignments will be included in each therapy session in the program. Participants will be followed-up at 18 weeks from the beginning of the intervention.

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 22, 2019
• Study Start: August 24, 2020
• Primary Completion: August 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)