Effectiveness and Implementation of a Digital Intervention for Pediatric Chronic Pain Co-designed With Patients

Study Overview
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Brief Summary
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Children and adolescents with chronic pain often lack a proper diagnosis and treatment. Research has shown that, if left untreated, it usually doesn't resolve and continues through adulthood. The goal of this multi-phase study is to co-develop (with patients), test, and implement a smartphone app called Digital Solution for Pain in Adolescents (Digital SPA) which can provide pain management resources to children with chronic pain and their parents, preventing future disability. Participants will: participate in individual and group interviews, respond to questionnaires online and try a smartphone app (adolescents) or a website (parents).

Detailed Description
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Phase 1) Focus groups with patients, parents and clinicians (n = 5-6 each) will inform about unmet pain care needs, and provide a starting point for co-designing the intervention. Phase 2) Content creation and usability testing will be based on the results of Phase 1 and the theory-driven development will follow the latest available evidence and the World Health Organization guidelines on the management of chronic pain in children. The intervention will use validated psychological techniques (particularly Cognitive Behavioral Therapy and Acceptance and Commitment Therapy) focused on improving functioning by teaching pain coping skills, such as: relaxation, goal setting, sleep management, behavioral activation, self-management of negative thoughts and emotions, and communication skills. Phase 3) Effectiveness and Implementation study. Participants (n = 195) will be adolescents 12-17 years old with chronic pain admitted into any of 6 large hospitals in Spain and one of their parents.

Official Title
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Effectiveness and Implementation of a Digital Intervention for Pediatric Chronic Pain Co-designed With Patients

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Digital SPA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adolescents age 12-17 years Has had non-oncologic chronic pain for at least 3 months (e.g., abdominal pain, headache or musculoskeletal pain) Has Internet access One parent is willing to participate (and both give consent for their child to participate) Exclusion Criteria: Diagnosis of a comorbid serious health condition (e.g., cancer) Parent or child does not speak or read Spanish Active psychosis or suicidal ideation

Ages Eligible for Study
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Minimum Age: 12 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
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: This study will employ a stepped wedge cluster randomized design in which hospitals are randomized sequentially to initiate the intervention. Prior to initiating patient recruitment, each of the 6 hospitals will be randomized to one of two waves in the stepped wedge design. During the non-exposure periods, patients will receive usual care from the hospital.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital SPA<br>A psychological intervention for chronic pain in adolescents administered using an app co-created with patients. | Behavioral: Digital SPA<br>* A psychological digital intervention for chronic pain in adolescents, based on evidence-based cognitive-behavioral and Acceptance and Commitment Therapy techniques. The intervention will be co-created with patients in a previous phase of the study, so the exact number or format of sessions and content has not been determined yet.<br>|
| No Intervention: Usual Care<br>Participants assigned to this arm will receive usual care from their hospital. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Interference | Spanish version of the Brief Pain Inventory (BPI) short version. Pain intensity scale scores range from from 0 to 10 , with higher scores indicating greater interference. Interference scores range from 0 to 10, with higher scores indicating greater interference. | Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3). | 
| Global impression of change after treatment | 11-point scale (0 to 10) with higher scores indicating greater impression of change. | Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3). | 
| Change in the number of visits to the Emergency Room (ER) due to pain | The number of visits to the ER due to pain during the follow-up period (T3 to T4; 3 months) will be compared with the three months before starting treatment (T1). | Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain readiness to change | Readiness to adopt a self-management approach to pain. The Spanish version of the Pain Stages of Change Questionnaire for Adolescents (PSoCQ-A). The Questionnaire has three scales: Pre-contemplation, Contemplation, and Action/Maintenance. Each scale is scored in a 1 to 5 Likert scale, with higher scores indicating a higher level of attitudes in that stage of change. The scale with the highest score indicates which stage the respondent is at. | Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3). | 
| Change in the dose of pain medication taken | The dose (eg. 25 mg per day) of pain medication taken will be recorded. | Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3). | 
| Change in the type of pain medication taken | The type (e.g. Non-steroid Anti-inflammatory Drugs, opioids) of pain medication taken will be recorded. | Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3). | 
| Change in Emotional Distress | The Spanish version of the Patient-Reported Outcomes Measurement Information System (PROMIS) emotional distress scale will be administered to assess anxiety and depression symptoms. The anxiety scale is scored in a 1 (never) to 5 (always) scale, with higher scores indicating more anxiety symptoms. The depression scale is scored in a 1 (never) to 5 (always) scale, with higher scores indicating more depression symptoms. | Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3). | 
| Change in Functional Disability | The Spanish version of the Functional Disability Inventory for adolescents (FDI) will be administered. 0 No trouble to 4 Impossible. The total FDI score can range from 0 to 60, with higher scores indicating higher levels of disability. | Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3). | 
| Change in Sleep | Sleep quality will be assessed with the Spanish version of the Pittsburgh Sleep Quality Index, validated for adolescents (PSQI). Scores on 7 components range from 0 to 3, and are the summed (global score range 0 to 21, with higher scores indicating worse sleep quality). Insomnia will be assessed with the Spanish version of the Adolescent Insomnia Questionnaire (AIQ). Total scores range from 0 to 52 with higher scores indicating more insomnia symptoms. | Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3). | 
| Change in Self-efficacy | Self-Efficacy Questionnaire for Children (SEQ-C). The perception of self-management skills after treatment will be assessed with this questionnaire. Each item has to be scored on a 5-point scale between 1 not at all and 5 very well. Total scores range from 21 to 105, with higher scores indicating more self-efficacy. | Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3). | 
| Satisfaction with treatment | The Treatment Evaluation Inventory will be administered. It ranges from 0 to 35, with higher scores indicating more satisfaction with the treatment. | Post-treatment (T3; 8 weeks after T1). | 
| Adherence to treatment | One measure of implementation will be adherence to the online intervention assessed collecting back-end data such as: number of log-ins or number of treatment sections completed. | From the moment the treatment app is downloaded (T1), to the completion of the treatment period (T3). Up to 10 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic pain, Adolescents, Digital Health, Psychological Intervention, Co-development, Implementation