Adolescent Behavior, Child Behavior, Chronic Pain, Exposure
Conditions
Brief summary
This project proposes to systematically develop and evaluate the feasibility and preliminary effectiveness of a digitally delivered, graded exposure treatment for youth with chronic musculoskeletal pain, utilizing a sequential replicated and randomized single-case experimental design (SCED). SCED provides the opportunity to rigorously evaluate treatment effectiveness at the individual level. Development of iGET Living will be based on a series of short iterations, with alpha testing (Aim 1) on a small sample of adolescents with chronic pain (N = 15). For Aim 1, participants will participate in one session (lasting 2 hours). In Aim 2, Participants will be enrolled in a baseline period ranging from 7-25 days (done to support SCED methodology) after which they will be enrolled in the online intervention program, lasting 6-weeks. Patients will be contacted 3-months post-discharge from treatment (week 22 of enrollment) and will complete self-report outcome measures at this time.
Interventions
BEHAVIORALGraded exposure treatment (GET)
Graded-exposure is a theory driven, individually tailored, and evidenced based behavioral intervention for individuals with chronic pain targeting pain-related impairment by exposing patients to previously feared and avoided activities.
Sponsors
Stanford University
Karolinska Institutet
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Youth ages 10-18 * Have diagnosis of chronic musculoskeletal pain (\>3months) * Have moderate to high pain interference (PROMIS Pain Interference ≥ 61) * English literate * Have access to computer, smartphone, or tablet with internet connection
Exclusion criteria
* Significant cognitive impairment (e.g., brain injury) * Significant medical or psychiatric problems that would interfere with treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Acceptability of Treatment Content - Likert Scale (Aim 1) | One day | Participant-rated acceptability measured on 5-point Likert scale. Range 0-4 (higher scores indicate more acceptable). Questionnaire will be administered to youth with chronic pain and their parents. |
| Participant Satisfaction With the Intervention (Aim 2) | 10 weeks (assessed at discharge) | Treatment satisfaction at the end of treatment will be evaluated by examining mean satisfaction scores on an adapted version of the Pain Service Satisfaction Test (PSST, McCracken et al., 1997). The PSST consists of 23 items rated on a 5-point Likert Scale (0 = not at all satisfied to 4 = very satisfied) and assesses the patient and parent's experience of the intervention. Scores range from 0-92. A score greater than/equal to 40 of 60 (satisfied to very satisfied) will indicate high levels of satisfaction with the intervention content. Caregivers were not assessed for this Outcome Measure. |
| Percentage of Participants Dropped Out of Intervention (Aim 2) | 10 weeks (Completed at discharge) | As a measure of treatment adherence, we will calculate the percentage of participants who drop out or withdraw from the intervention prior to completion of the intervention. |
| Expectations for Treatment (Aim 2) | Assessed seven days after starting the intervention (7 days post-baseline) | To assess expectations for treatment effectiveness, participants completed the Credibility/Effectiveness Questionnaire (CEQ; Borkovec \& Nau, 1972) after engaging with iGET Living for one week. The CEQ consists of six items rated on a 0 (not at all) to 10 (very much) Likert scale and assesses expectations related to the effects of the intervention across two subscales: Credibility (e.g., "How confident would you be recommending iGET Living to a friend with the same problems?") and Expectancy (e.g., "By the end of iGET Living, how much do you think your functioning will improve?"). Credibility is calculated by summing items 1-3 and Expectancy by summing items 4-6. Possible range of scores for each subscale is 0-30, with higher scores reflecting greater perceived credibility and expectancy. |
| Functional Disability (Aim 2) | Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge) | Functional disability will be assessed using the Functional Disability Inventory (FDI, Walker \& Greene, 1991), a 15-item self-report measure of perceived difficulty in performing activities in school, home, physical, and social contexts. Items are rated on a 5-point Likert scale ranging from 0 (no trouble) to 4 (impossible). Scores from all the Items are summed to create a total score (range 0-60), with higher scores indicating greater disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child Fear of Pain (Aim 2) | Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge) | Fear of Pain Questionnaire, Child Report, Short Form (FOPQ-C-SF, Heathcote et al., 2020) is a 10-item self-report measure that assesses pain-related fear and avoidance of activities. Items are rated on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). Scores from all the Items are summed to create a total score ranging from 0 - 40. Higher scores indicate higher levels of pain-related fear and avoidance (worst outcome). |
| Parental Fear of Pain (Aim 2) | Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge) | The Parent Fear of Pain Questionnaire (PFOPQ, Simons et al., 2015) assesses parent's fear associated with their child's pain experiences. The PFOPQ contains 23 items assessed on a 5-point Likert scale (0 = "strongly disagree" to 4 "strongly agree"). Items are summed to create a total score (0-92), with higher scores indicated greater parent fear associated with their child's pain. |
| Child Pain Catastrophizing (Aim 2) | Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge) | The Pain Catastrophizing Scale -Child Version (PCS-C, Crombez et al., 2003) assesses negative cognitions associated with pain. The PCS-C is comprised of 13-items rated on a 5-point Likert scale (0= "not at all true" to 4 "very true"). A total score (0-52) is obtained by summing all items. Higher scores indicate higher levels of catastrophic thinking. |
| Parent Pain Catastrophizing (Aim 2) | Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge) | Pain Catastrophizing Scale-Parent Version (PCS-P, Goubert et al., 2006) assesses parents' negative cognitions associated with their child's pain. It is comprised of 13 items rated on a 5-point Likert scale (0 = "not true at all" to 4 = "very true"). A total score (0-52) is derived by summing items, with higher scores indicating higher levels of catastrophic thinking. |
| Child Pain Acceptance (Aim 2) | Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge) | Child report on the Chronic Pain Acceptance Questionnaire for Adolescents-short form (CPAQ-A8, Gauntlett-Gilbert et al., 2018) will be used to assess pain acceptance in the child. The CPAQ-A8 is an 8-item measure consisting of two subscales: Activity Engagement (4 items) and Pain Willingness (4 items). Items are rated on a 5-point Likert scale ranging from 0 (Never True) to 4 (Always True) and yield a total score for each subscale ranging from 0-16. Higher scores indicate greater Activity Engagement and greater Pain Willingness (positive outcome) . |
| Parent Psychological Flexibility (Aim 2) | Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge) | The Parent Psychological Flexibility Questionnaire (PPFQ-10, Timmers et al., 2019) is a 10-item parent self-report questionnaire assessing a parent's ability to accept their own distress and respond adaptively and flexibly to their child's pain. Items are rated on a 5-point Likert scale (0= " never true" to 4 = "always true") and are summed to create a total score, ranging from 0 - 40. Higher scores indicate greater parent psychological flexibility (positive outcome). |
| Parent Responses to Childs Pain (Aim 2) | Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge) | Adult Responses to Children's Symptoms (ARCS, Claar et al., 2010) assesses parents' behavioral responses to children's pain behaviors. The Protect subscale (13 items) will be utilized in this study. The Protect scale refers to protective parental behavior, such as giving the child special attention and limiting the child's normal activities and responsibilities. All items are rated on a 5-point Likert scale (0 = "never" to 4 "always"), and are averaged to create a total score ranging from 0-4. Higher scores indicating greater use of protective behavioral responses to their child's pain (worst outcome). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLauren E Harrison, PhD
Stanford University
Participant flow
Recruitment details
For Aim 1 (one time study visit), youth of chronic pain and caregivers of youth with chronic pain were recruited. However, these were not exclusively dyads. For Aim 2 (intervention), youth-caregiver dyads were recruited and enrolled.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 53 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants |
| Race (NIH/OMB) White | 69 Participants |
| Region of Enrollment United States | 17 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 17 | 0 / 38 | 0 / 38 |
| other Total, other adverse events | 0 / 15 | 0 / 17 | 0 / 38 | 0 / 38 |
| serious Total, serious adverse events | 0 / 15 | 0 / 17 | 0 / 38 | 0 / 38 |
Outcome results
None listed