Cognitive Behavioral Pain Management Program for Children and Youth With Cerebral Palsy (CBPM_CP): a Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cerebral Palsy
- Sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Proportion of eligible participants that are recruited as study participants during the study timeline [Feasibility]
- Last Updated
- 5 years ago
Overview
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.
Detailed Description
Children with CP often experience pain that is related to their medical condition and that may limit or interfere with their everyday activities and Quality of Life (QoL).One possible way to help these children is by using a modified cognitive behavioral therapy (CBT) for pain management. For this study, the investigators want to do a feasibility study, to see if participating in a six-week pain management CBT program for children and youth with CP and their parents, leads to better pain coping skills and lower levels of pain interference, when compared to a controlled waiting list. Participants in both groups (immediate and delayed treatment) will participate in a 2-hour CBT session, once a week, for a total of six weeks. Following 3-months from the last CBT session, participants will be contacted for a short follow-up screening. All participants will be enrolled in the study for a total of 18 weeks. This study will be done at the Holland Bloorview Kids Rehabilitation Hospital, Toronto, Canada. Sixteen participants with CP (gross motor function classification system (GMFCS) levels I-V), age 8 to 18, with evidence of chronic pain (detailed as pain lasting more than 3 months or lasting longer than the expected time to heal) and their parents, will be recruited for participation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Proportion of eligible participants that are recruited as study participants during the study timeline [Feasibility]
Time Frame: 18 weeks
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.
Proportion of recruited participants that completed 80% of the in-between session assignments during the intervention phase [Feasibility].
Time Frame: 18 weeks
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.
Proportion of recruited participants that attended the follow-up session 18 weeks from baseline [Feasibility].
Time Frame: 18 weeks
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.
Pediatric Pain Interference Scale [PPIS]
Time Frame: Changes in PPIS from baseline to 6 and 18 weeks
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.
Proportion of recruited participants that attend in 80% of the 6 study sessions during the intervention phase [Feasibility]
Time Frame: 18 weeks
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.
Secondary Outcomes
- 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)
- Chronic Pain Acceptance Questionnaire-Parent [CPAQ-P](Changes in CPAQ-P from baseline to 6 and 18 weeks)
- The Faces Pain Scale-Revised [FPS-R](Changes in pain intensity from baseline to 6 and 18 weeks)
- Pain Stages of Change Questionnaire-Parents [PSOCQ-P](Changes in PSOCQ-P from baseline to 18 6 and weeks)