Trial record 1 of 1 for:    NCT01316471
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Internet Intervention for Adolescents With Chronic Pain

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tonya Palermo, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01316471
First received: March 11, 2011
Last updated: September 8, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to evaluate the efficacy of a web-based (i.e., internet) behavioral program to reduce pain and improve functioning in children and adolescents with chronic pain. We hypothesize that children and adolescents in families that receive the web-based behavioral program will report reduced pain levels and improved daily functioning compared to children and their parents who receive online patient education.


Condition Intervention Phase
Chronic Pain
Abdominal Pain
Headache
Behavioral: Online Behavioral Intervention
Other: Education: Online Patient Education
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Web-MAP 2: Internet Intervention for Adolescents With Chronic Pain

Resource links provided by NLM:


Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • Change in Activity Limitations from Baseline to Immediately Post-Treatment, 6-month follow-up, and 12-month follow-up [ Time Frame: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up ] [ Designated as safety issue: No ]
    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 10 days at each assessment period.

  • Change in Pain from Baseline to Immediately Post-Treatment, 6-month follow-up, and 12-month follow-up [ Time Frame: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up ] [ Designated as safety issue: No ]
    Children will report on presence and intensity of pain daily for 10 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). Each time period will have three pain indices calculated: (1) the sum of all pain reports (range 0 to 100), (2) the mean intensity of the pain reported (range 0 to 10), and (3) the number of pain-free days (range 0 to 10). Clinically significant improvement will be defined as 50% reduction in the sum of all pain reports.


Secondary Outcome Measures:
  • Depression and pain-specific anxiety [ Time Frame: pre-treatment, immediately post-treatment, 6-month follow-up, 12-month follow-up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.

  • Service Use [ Time Frame: pre-treatment, 12-month follow-up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 600
Study Start Date: May 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

An estimated 15% to 30% of otherwise healthy children and adolescents suffer from recurrent or chronic pain such as headache, abdominal pain, and musculoskeletal pain. Chronic pain has a significant impact on children's mood, daily functioning, and overall quality of life. Effective behavioral interventions have been developed to increase positive coping behaviors. However, most children do not have access to these interventions due to a variety of barriers such as distance from pediatric pain treatment centers. We have developed an online behavioral intervention called Web-based Management of Adolescent Pain (Web-MAP), and our preliminary findings indicated that children in families that received this intervention experienced significant improvements in their pain level and daily functioning compared to children who did not receive the intervention (Palermo et al., 2009). The purpose of this study is to extend these findings by: 1) recruiting families from other medical centers, 2) determining whether the benefits of online behavioral intervention are maintained 6- and 12-months after the intervention has been completed, 3) evaluating additional outcomes such as parent responses to pain and child sleep quality, anxiety, depression, and health service use, 4) comparing results from online behavioral intervention to online patient education.

  Eligibility

Ages Eligible for Study:   11 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Literate in English
  • Age 11-16 years
  • Pain present for at least 3 months duration
  • Pain occurs at least 1 time per week and interferes with daily functioning
  • Pain is not related to a chronic disease
  • Receiving evaluation or treatment in a pediatric pain clinic
  • Has access to a computer, the Internet, and a phone

Exclusion Criteria:

  • A serious comorbid chronic condition in the patient (e.g., diabetes, arthritis, cancer).
  • Non-English speaking
  • More than 4 sessions of outpatient psychological therapy for pain management in the 6 months prior to the time of screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316471

Locations
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
Principal Investigator: Tonya M. Palermo, Ph.D. University of Washington Medical School
  More Information

Publications:
Responsible Party: Tonya Palermo, Professor, Department of Anesthesia and Pain Medicine, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01316471     History of Changes
Other Study ID Numbers: R01HD062538-01A1
Study First Received: March 11, 2011
Last Updated: September 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Seattle Children's Hospital:
Chronic Pain
Abdominal Pain
Headache
Adolescents
Internet Interventions
Behavioral Interventions

Additional relevant MeSH terms:
Abdominal Pain
Chronic Pain
Headache
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 23, 2014