Agile Development of a Digital Exposure Treatment for Youth With Chronic Musculoskeletal Pain

Study Overview
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Brief Summary
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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) and their parents (N = 15). For Aim 1, participants will participate in three, two hour focus groups (one per week over the course of three weeks), resulting in 6 total hours of participation per participant for Aim 1. Aim 2 will involve a sample (N = 20 youth, N = 20 parents) of naïve end-users. 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.

Official Title
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Agile Development of a Digital Exposure Treatment for Youth With Chronic Musculoskeletal Pain

Conditions
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Adolescent Behavior, Child Behavior, Chronic Pain, Exposure

Intervention / Treatment
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* Behavioral: Graded exposure treatment (GET)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Youth ages 10-17 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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Graded Exposure Intervention<br>For Aim 2, adolescents with chronic pain will be enrolled in a single-arm feasibility trial examining acceptability, feasibility, and preliminary effectiveness of a novel, digitally delivered, graded exposure treatment. | Behavioral: Graded exposure treatment (GET)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Acceptability of Treatment Content and Digital Delivery Questionnaire - Likert Scale (Aim 1 and Aim 2) | 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. | Baseline through 3-month follow-up (up to 22 weeks) | 
| Assessment of Acceptability of Treatment Content and Digital Delivery Questionnaire - Participant Responses (Aim 1 and Aim 2) | Acceptability will be assessed qualitatively through participant responses to open-ended questions related to acceptability, ease of use, comprehensibility, and suggestions for improvement. Responses will be assessed categorically by the investigator. Questionnaire will be administered to youth with chronic pain and their parents. | Baseline through 3-month follow-up (up to 22 weeks) | 
| Participant Satisfaction with the Intervention (Aim 1 and 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. | 19 weeks (Assessed at the end of treatment) | 
| 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. | 19 weeks (Assessed at the end of treatment) | 
| Expectations for Treatment (Aim 2) | Participants (child) and parent expectations for treatment will be measured by the Treatment Expectancy and Creditability, Borkovec & Nau, 1972). The TEC is comprised of 6 items rated on a 0 to 10 Likert-scale assessing expectations related to the effectiveness of the current treatment. The TEC is completed by the patient at the end of the first treatment session. Higher scores indicate greater expectations for treatment effectiveness. | Baseline (up to 2 minutes to complete the survey) | 
| 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). Items are summed to create a total score (range 0-60), with higher scores indicating greater disability. | Baseline through 3-month follow-up (up to 22 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Fear of Pain (Aim 2) | Fear of Pain Questionnaire- Child (FOPQ-C, Simons et al., 2011) consists of 24 items, with each item rated on a 5-point Likert scale (0 = strongly disagree to 4 = strongly agree). The FOPQ-C contains two subscales: Fear of Pain (11 items) and Avoidance of Activities (13 items). Total score is derived by summing subscale items, with higher scores indicating greater pain related fear (score range 0-44) and avoidance of activities (score range 0-52). | Baseline through 3-month follow-up (up to 22 weeks) | 
| 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. | Baseline through 3-month follow-up (up to 22 weeks) | 
| 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. | Baseline through 3-month follow-up (up to 22 weeks) | 
| 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. | Baseline through 3-month follow-up (up to 22 weeks) | 
| Child Pain Acceptance (Aim 2) | 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 . | Baseline through 3-month follow-up (up to 22 weeks) | 
| 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. | Baseline through 3-month follow-up (up to 22 weeks) | 
| 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. Hiigher scores indicating greater use of a particular type of response to their child's pain. | Baseline through 3-month follow-up (up to 22 weeks) |