NCT Number: NCT03332563
Approximately 5-8% of children report severe chronic pain and disability. Although evidence supports pain-self management as effective for reducing pain and disability, data show that most youth do not have access to this intervention. The investigative team's prior studies demonstrate that technology-delivered pain self-management (WebMAP program) can reduce barriers to care, is feasible, acceptable, and effective in reducing pain-related disability and improving anxiety and depression in youth with chronic pain. In this trial, the investigators propose an implementation project to address critical challenges in nationwide dissemination of the WebMAP pain self-management program. Using a hybrid effectiveness-implementation trial design, 8 clinics from across the U.S. will participate in a pragmatic randomized controlled trial with a stepped wedge design to sequentially implement WebMAP in the clinics following randomized usual care periods. Data will be collected from clinic records, web and app administrative tracking, and provider surveys to gather information on adoption and implementation following the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) public health impact framework. Individual patient-level pain outcomes will be collected from 140 patients to evaluate intervention effectiveness. The expected outcome of the project is to yield a strategic approach for a nationwide technology-delivered pain self-management intervention for youth with chronic pain that can be readily sustained in clinical settings.
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Notify Me10 year–17 year
All sexes
Interventional
Not applicable
Connecticut Children's Medical Center, Hartford, Connecticut, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
WebMAP is a technology-based cognitive-behavioral intervention program that teaches relaxation skills, pain coping strategies and parent behavioral and communication techniques to youth with chronic pain and their parents.
Time frame: Baseline to 3 month followup
The 9-item Child Activity Limitations Interview (CALI-9) will be completed on the online diary to rate perceived difficulty in completing 9 daily activities due to pain
Time frame: Baseline to 3 month followup
Pain intensity will be measured prospectively on the 11-point Pain Numeric Rating Scale (NRS) with anchors of 0 (no pain) to 10 (worst pain possible). Average scores over 7-day assessment periods will be used in analyses.
Time frame: Baseline to 3 month followup
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Emotional Distress scale is an 8-item scale of anxiety with scores ranging from 8 to 40 (higher scores indicate greater fear, anxious misery, and hyperarousal). The 8-item scale of depressive symptoms has scores ranging from 8 to 40 with higher scores indicating greater depressive symptoms. Total anxiety and total depression T-scores will be used in analyses.
Time frame: Baseline to 3 month followup
Pain Self-Efficacy Scale-4 is a 4-item measure that assesses beliefs in carrying out activities when in pain. Total sum score ranging from 0 to 24 will be used in analysis with higher scores representing greater self-efficacy.
Time frame: 3 month followup
1-item measure asking about change since receiving treatment
Time frame: Baseline to 3 month followup
Parents report on their protective behaviors on the Adult Responses to Child Symptoms (ARCS), a 29-item scale with subscale scores for three factors, Protect, Minimize, Distract and Monitor. Each subscale is scored by computing the mean of the item responses ranging from 0 to 4 (higher scores indicate more maladaptive behaviors)
Time frame: Baseline to 3 month followup
Parents report on their anxiety and depression symptoms on the PROMIS Adult Emotional Distress scale. This includes a 4-item scale of anxiety with scores ranging from 4 to 20 (higher scores indicate greater anxiety), and a 4-item scale of depression with scores ranging from 4 to 20 (higher scores indicate greater depression. Total anxiety and depression scale T-scores will be used in analyses.
Time frame: Baseline to 3 month followup
Insomnia Severity Index is a 7-item self-report measure. A 5-point Likert scale is used to rate each item about the severity and impact of insomnia symptoms with scores ranging from 0 to 28 (higher scores indicate greater insomnia sympotoms). A Total score will be used in analyses.
Time frame: Assessed at 24 months
Proportion of children referred to WebMAP at each clinic/Number seen in each clinic
Time frame: Assessed at 24 months
Number of people agree to participate/Number of eligible participants referred for intervention
Time frame: Assessed at 24 months
Provider survey regarding feasibility of implementing WebMAP and attitudes toward adoption
Time frame: Assessed at 24 months
Proportion of clinics agreeing to continue using WebMAP
Seattle Children's Hospital
Other
Web-based Self-management of Adolescent Chronic Pain: National Implementation Project
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