Clinical trial NCT04174326: CBT Program for Pain Management for Children and Youth With CP (CBT=Cognitive Behavioral Therapy; CP= Cerebral Palsy)
Official title: Cognitive Behavioral Pain Management Program for Children and Youth With Cerebral Palsy (CBPM_CP): a Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Chronic Pain
Keywords: Cognitive Behavioral Therapy
Lead sponsor: Holland Bloorview Kids Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 8
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of CP
2. Chronic pain lasting greater than 3 months and restricting some or all activities according to child/youth/parental self-report
3. 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
4. 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
5. Parent agreement to participate in the parents' program
6. 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:

1. Diagnosis of major visual or hearing impairment
2. Currently attending psychological treatment focused on pain management; (3) Uncontrolled seizure(s) (with or without medication) in the previous 12 months.

Primary outcomes:
measure: Pediatric Pain Interference Scale [PPIS]
timeFrame: Changes in PPIS from baseline to 6 and 18 weeks
measure: Proportion of eligible participants that are recruited as study participants during the study timeline [Feasibility]
timeFrame: 18 weeks
measure: Proportion of recruited participants that attend in 80% of the 6 study sessions during the intervention phase [Feasibility]
timeFrame: 18 weeks
measure: Proportion of recruited participants that completed 80% of the in-between session assignments during the intervention phase [Feasibility].
timeFrame: 18 weeks
measure: Proportion of recruited participants that attended the follow-up session 18 weeks from baseline [Feasibility].
timeFrame: 18 weeks
Secondary outcomes:
measure: The Faces Pain Scale-Revised [FPS-R]
timeFrame: Changes in pain intensity from baseline to 6 and 18 weeks
measure: Psychological Inflexibility in Pain Scale [PIPS]
timeFrame: Changes in pain coping from baseline to 6 and 18 weeks
measure: KIDSCREEN-27 Health related quality of life [HRQoL]
timeFrame: Changes in HRQoL from baseline to 18 weeks
measure: Pain Stages of Change Questionnaire-Parents [PSOCQ-P]
timeFrame: Changes in PSOCQ-P from baseline to 18 6 and weeks
measure: Chronic Pain Acceptance Questionnaire-Parent [CPAQ-P]
timeFrame: Changes in CPAQ-P from baseline to 6 and 18 weeks
Other outcomes:
measure: Canadian Occupational Performance Measure [COPM]
timeFrame: Changes in COPM from baseline to 18 weeks
measure: Pediatric Rehabilitation Intervention Measure of Engagement - Service Provider [PRIME-SP]
timeFrame: Change in engagement in intervention session from baseline to 18 weeks.
Locations:
city: Toronto
country: Canada
facility: Holland-Bloorview Kids Rehabilitation Hospital
state: Ontario
Study officials:
affiliation: Holland Bloorview Kids Rehabilitation Hospital
name: Darcy Fehlings, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: