Internet Intervention for Adolescents With Chronic Pain
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|ClinicalTrials.gov Identifier: NCT01316471|
Recruitment Status : Completed
First Posted : March 16, 2011
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain Abdominal Pain Headache||Behavioral: Online Behavioral Intervention Other: Education: Online Patient Education||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||273 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Web-MAP 2: Internet Intervention for Adolescents With Chronic Pain|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Experimental: Online Behavioral Intervention
In addition to standard medical care, children and parents in the online behavioral intervention will receive access to the full web-based program including education about chronic pain, training in behavioral and cognitive coping skills, instruction in increasing activity participation, and education about pain behaviors and parental operant strategies using an engaging, interactive format on the Internet.
Behavioral: Online Behavioral Intervention
The online behavioral intervention is travel-themed and participants visit 8 destinations (1 per week) designed to take 30 min each to complete. The destinations serve as an online analog for the weekly sessions used when delivering behavioral interventions face-to-face. The 8 child destinations include: 1) education about chronic pain, 2) recognizing stress and negative emotions, 3) relaxation and distraction skills, 4) school, 5) cognitive skills, 6) sleep hygiene and lifestyle, 7) staying active, and 8) relapse prevention. The eight parent destinations include: 1) education about chronic pain, 2) recognizing stress and negative emotions, 3) operant strategies I, 4) operant strategies II, 5) modeling, 6) sleep hygiene and lifestyle, 7) communication, and 8) relapse prevention.
Other Name: Internet Intervention
Active Comparator: Online Patient Education
The Online Patient Education group will serve as an attention control condition. In addition to standard medical care, children and parents will be provided with access to a modified version of the study website that will provide information from publicly available educational websites about pediatric chronic pain management.
Other: Education: Online Patient Education
The purpose of the online patient education group is to control for time, attention, and computer usage. Children and parents will be provided with access to a modified version of the study website that will provide links to information from publicly available educational websites about pediatric chronic pain management. Children and parents will log onto the web program weekly at the same interval as the Online Behavioral Intervention group. Children and parents will be asked to view 3 links each week and then report a few details pertaining to the content of what they viewed.
Other Name: Online Attention Control
- Activity limitations [ Time Frame: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up ]Child report of activity limitations will be assessed using the prospective version of the Child Activity Limitations Interview (Palermo, Witherspoon, Valenzuela, & Drotar, 2004), which includes 8 activities that children identify as important in their day-to-day lives that are impacted by pain. Responses are rated on a 5-point scale (0-4) with higher scores indicating greater perceived difficulty with activities. Children will provide ratings daily for 7 days on their online diaries at each assessment period. Mean activity limitations across the reporting period is used in analyses.
- Pain intensity [ Time Frame: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up ]Children will report on presence and intensity of pain daily for 7 days at each assessment period. Pain intensity will be assessed using an 11-point numerical rating scale (NRS) with anchors of 0= no pain to 10= worst pain (McGrath et al., 2008). Mean average intensity of the pain reported will serve as primary pain measure.
- Depression and pain-specific anxiety [ Time Frame: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up ]Children will complete the Bath Adolescent Pain Questionnaire (BAPQ), a 61-item scale that will be used to measure pain-specific emotional functioning (Eccleston et al., 2005). The BAPQ was developed specifically for children with chronic pain and has demonstrated adequate reliability and validity (Eccleston et al., 2008). For the purpose of this study, the subscales of depression and pain-specific anxiety will be used in analyses.
- Treatment Satisfaction [ Time Frame: Immediately Post-Treatment, 6-month follow-up, 12-month follow-up ]Children and parents will complete this questionnaire, which includes items that address satisfaction with the therapeutic process during the course of treatment and satisfaction with the outcome of therapy. Items are rated on a 5-point scale from 1 = strongly disagree to 5 = strongly agree.
- Parental Response to Pain Behavior [ Time Frame: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up ]Children and their parents will complete the Adult Responses to Children's Symptoms (ARCS), a 29-item measure assessing parental responses to child pain behavior (Walker, Levy, & Whitehead, 2006). Respondents rate on a five-point Likert scale the frequency with which parents engage in specific behaviors in response to their child's pain.
- Sleep Quality [ Time Frame: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up ]Children's perception of sleep quality will be measured by the Adolescent Sleep Wake Scale (LeBourgeois et al., 2005), a 28-item self-report scale that assesses five behavioral dimensions of teens' sleep: going to bed, falling asleep, maintaining sleep, reinitiating sleep, and returning to wakefulness. Subscale scores range from 1 to 6, with higher scores indicating better sleep quality.
- Health service Use [ Time Frame: pre-treatment, 12-month follow-up ]Parents will complete the Client Service Receipt Inventory-Pain version (Sleed et al., 2005), a measure of service use, out-of-pocket expenses, and lost work time incurred by families for the evaluation or management of the child's chronic pain. Questions pertain to hospital admissions, outpatient services, community services (e.g., tutor, lawyer), medications, lost work time, paid help, and other costs. We will compute the following variables: total number of services used, number of lost parental work days, and number of out-of-pocket expenses.
- Miscarried Helping [ Time Frame: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up ]Parents and adolescents will complete the Helping for Health Inventory (Harris et al., 2008), a 15-item scale that measures miscarried helping or negative social support. Respondents rate on a 5-point scale the frequency with which parents engage in certain behaviors or feel certain ways pertaining to their child's health.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01316471
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|Principal Investigator:||Tonya M. Palermo, Ph.D.||University of Washington Medical School|