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

Study 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.

Official Title
-----------------
Cognitive Behavioral Pain Management Program for Children and Youth With Cerebral Palsy (CBPM_CP): a Feasibility Study

Conditions
-----------------
Cerebral Palsy, Chronic Pain

Intervention / Treatment
-----------------
* Behavioral: Immediate intervention group


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>A weekly 2 hour CBT for chronic pain group intervention for a duration of 6 weeks | Behavioral: Immediate intervention group<br>* 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.<br>* Other names: Immediate;|
| No Intervention: Delayed intervention group<br>A waiting list for CBT for chronic pain group intervention. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Faces Pain Scale-Revised [FPS-R] | The Faces Pain Scale - Revised [FPS-R] is a self-report measure of pain intensity developed for children. The scale shows a close linear relationship with visual analog pain scales across the age range of 4-16 years. It is easy to administer and requires no equipment except for the photocopied faces. Numerical self-rating scales (0-10, with 0 equals No pain and 10 equals Very much pain) can be used with most children older than 8 years of age and behavioral observation scales are required for those unable to provide a self-report. Decrease in pain intensity is considered a better outcome | Changes in pain intensity from baseline to 6 and 18 weeks | 
| Psychological Inflexibility in Pain Scale [PIPS] | The Psychological Inflexibility in Pain Scale (PIPS) is a screening tool used to measure pain willingness and activities engagement of individuals living with chronic pain. It emphasizes the willingness to experience pain rather than trying to control or reduce pain symptoms. The tool was developed for adults and has been used with children and adults ages 8 - 84 years. It is a 16- item tool that consists of two subscales, avoidance and cognitive function. Participants rate how true the statements are on a 7-point Likert scale ranging from 'never true' to 'always true', with mean scores ranging from 1-7. Higher scores indicate greater levels of psychological inflexibility. Decrease in pain inflexibility is considered a better outcome | Changes in pain coping from baseline to 6 and 18 weeks | 
| KIDSCREEN-27 Health related quality of life [HRQoL] | The KIDSCREEN-27 questionnaire will be used for evaluating Health related quality of life. The questionnaire consists of 27 items which are used to assess HRQoL across 5 dimensions: Physical Well-Being (5 items); ; Psychological Well-Being (7 items) ; Parent Relations & Autonomy (7 items); Social Support & Peers (4 items), and; School Environment (4 items). The items assess either the frequency of behavior/feelings or, in fewer cases, the intensity of an attitude and are answered on a five-point scale. Mean scores range between 1-5 with higher values indicating higher health related quality of life. Increase in health related quality of life is considered a better outcome. | Changes in HRQoL from baseline to 18 weeks | 
| Pain Stages of Change Questionnaire-Parents [PSOCQ-P] | Pain Stages of Change Questionnaire will be used to assess parents' own levels of readiness to encourage their child to adopt a self-management approach to pain treatment. The Pain Stages of Change Questionnaire-Parents (PSOCQ-P) yields four validated subscales: Precontemplation, Contemplation, Action, and Maintenance, with precontemplation being the least ideal and indicating no consideration by the parent of having the child adopt a self-management approach to pain treatment. Mean scores on each scale range between 1 to 5, with higher scores indicating stronger endorsement of items representing each readiness stage domain. A decrease in Precontemplation and Contemplation scores and increase in Action and Maintenance scores indicate better outcome. | Changes in PSOCQ-P from baseline to 18 6 and weeks | 
| Chronic Pain Acceptance Questionnaire-Parent [CPAQ-P] | The Chronic Pain Acceptance Questionnaire- (parent version) (CPAQ-P) assesses parents' beliefs about child's acceptance of pain. The CPAQ-P consists of 16 items scored on a Likert scale of 0 = never true to 6 = always true. The 16 items comprise two subscales: Activity Engagement (9 items) and Pain Willingness (7 items). Activity engagement reflects the degree of participation in regular daily activities in the presence of pain (e.g. My life is going well, even though I have chronic pain). Pain willingness reflects the absence of attempts to avoid or control pain (e.g. I avoid putting myself in situations where my pain might increase - reverse keyed). Mean scores on each scale range between 1-6. Higher scores on both scales indicate greater parental beliefs about child acceptance of pain. An increase in scores on both scales is considered a better outcome. | Changes in CPAQ-P from baseline to 6 and 18 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognitive Behavioral Therapy