Cerebral PalsyCBT;CPNCT04174326
CBT Program for Pain Management for Children and Youth With CP (CBT=Cognitive Behavioral Therapy; CP= Cerebral Palsy)
A study testing Immediate intervention group in people with Cerebral Palsy and Chronic Pain, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Cerebral Palsy, Chronic Pain
- What is being tested?
- Immediate intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 24 Aug 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Behavioral Pain Management Program for Children and Youth With Cerebral Palsy (CBPM_CP): a Feasibility Study
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.
Read the 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.
- Conditions
- Cerebral Palsy, Chronic Pain
- Being tested
- Immediate intervention group
- Keywords
- Cognitive Behavioral Therapy
- Medical subject headings
- Cerebral Palsy, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate intervention groupBehavioural
Also called Immediate
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | A weekly 2 hour CBT for chronic pain group intervention for a duration of 6 weeks Receives: Behavioral: Immediate intervention group |
| Delayed intervention group | No intervention | A waiting list for CBT for chronic pain group intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18 weeks
Secondary outcomes (5)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Changes in CPAQ-P from baseline to 6 and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start24 Aug 2020
- Primary completionAug 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Darcy Fehlings, MD, MSc, Principal investigator, Holland Bloorview Kids Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174326
- Sponsor's protocol ID
- REB19-850
- Acronym
- CBT;CP
- Status last verified
- Jan 2021
- First submitted
- 20 Nov 2019
- Last updated
- 27 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Pain Management Program for Children and Youth With Cerebral Palsy (CBPM_CP): a Feasibility Study
- ClinicalTrials.gov ID
- NCT04174326
- Acronym / sponsor ID
- CBT;CP / REB19-850
- Conditions
- Cerebral Palsy, Chronic Pain
- Keywords
- Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Immediate intervention groupA weekly 2 hour CBT for chronic pain group intervention for a duration of 6 weeks |
| Delayed intervention group | No intervention | –A waiting list for CBT for chronic pain group intervention. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate intervention groupAlso: ImmediateParticipants 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. | Behavioural | Intervention group |
Primary 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 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 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.
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.
5 secondary outcomes
The Faces Pain Scale-Revised [FPS-R]
Time frame: Changes in pain intensity from baseline to 6 and 18 weeks
Psychological Inflexibility in Pain Scale [PIPS]
Time frame: Changes in pain coping from baseline to 6 and 18 weeks
KIDSCREEN-27 Health related quality of life [HRQoL]
Time frame: Changes in HRQoL from baseline to 18 weeks
Pain Stages of Change Questionnaire-Parents [PSOCQ-P]
Time frame: Changes in PSOCQ-P from baseline to 18 6 and weeks
Chronic Pain Acceptance Questionnaire-Parent [CPAQ-P]
Time frame: Changes in CPAQ-P from baseline to 6 and 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darcy Fehlings, MD, MSc principal investigator
Holland Bloorview Kids Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate intervention group in people with Cerebral Palsy and Chronic Pain, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Pain Interference Scale [PPIS] (time frame: Changes in PPIS from baseline to 6 and 18 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021; AzTrials last refreshed its copy on 6 Nov 2026.