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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
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.
Pediatric Pain Management Clinic
Menlo Park, California, United States
Assessment of Acceptability of Treatment Content - Likert Scale (Aim 1)
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.
Time frame: One day
Participant Satisfaction With the Intervention (Aim 2)
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.
Time frame: 10 weeks (assessed at discharge)
Percentage of Participants Dropped Out of Intervention (Aim 2)
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.
Time frame: 10 weeks (Completed at discharge)
Expectations for Treatment (Aim 2)
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.
Time frame: Assessed seven days after starting the intervention (7 days post-baseline)
Functional Disability (Aim 2)
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.
Time frame: Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
Child Fear of Pain (Aim 2)
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).
Time frame: Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
Parental Fear of Pain (Aim 2)
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.
Time frame: Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
Child Pain Catastrophizing (Aim 2)
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.
Time frame: Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
Parent Pain Catastrophizing (Aim 2)
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.
Time frame: Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
Child Pain Acceptance (Aim 2)
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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) .
Time frame: Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
Parent Psychological Flexibility (Aim 2)
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).
Time frame: Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
Parent Responses to Childs Pain (Aim 2)
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).
Time frame: Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)