- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04046562
Pain and Weight Treatment: Development and Trial of PAW (PAW)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Melissa Santos, PhD
- Phone Number: 860-837-6739
- Email: Msantos@connecticutchildrens.org
Study Locations
-
-
Connecticut
-
Hartford, Connecticut, United States, 06106
- Recruiting
- Connecticut Children's Medical Center
-
Contact:
- Melissa Santos, PhD
- Phone Number: 860-867-6739
- Email: Msantos@connecticutchildrens.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Males and females between 12 and 18 years of age
- Ability to speak, write and read English
- A parent or guardian who speaks, writes and reads English
- Signed consent and assent from the child and parent
- Enrollment in a weight management program
- Score greater than 3 on the Pain Burden Inventory at screening (in order to recruit adolescents who experience more than just general aches and pains).
- Youth reporting musculoskeletal pain
Exclusion Criteria:
- Parent or guardian unable to participate
- Patients on weight reducing medications
- Severe psychiatric illness (i.e., suicidal or hospitalization within past 6 months)
- Medical conditions such as Type 1 diabetes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: PAW plus standard of care
Each PAW session will include handouts and worksheets to assist with new strategies as well as homework.
Strategies taught within PAW will be integrated with the skills taught in weight management.
For example, pain diaries will be kept along with food and exercise logs to examine relationships among pain, eating and activity.
|
Pain and Weight Treatment plus standard of care
|
Placebo Comparator: Pain education plus standard of care
For those randomized into the information-only group, sessions will be delivered in the same manner.
Sessions will cover general pediatric pain management but no behavioral or cognitive skills training will be taught.
|
Pain Education plus standard of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean difference in session attendance between groups
Time Frame: Through the 13 weeks that comprise fit5
|
The number of sessions of fit5 attended will be compared between the group attending PAW and those in the information control group.
|
Through the 13 weeks that comprise fit5
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The feasibility and acceptability of the PAW intervention will be examined Via exit interviews
Time Frame: At the conclusion of the 13 weeks of the program
|
At the exit interviews, we will inquire with families whether 4 sessions felt sufficient, whether they would have liked more or less sessions and when they would have liked sessions scheduled.
|
At the conclusion of the 13 weeks of the program
|
The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.
Time Frame: At the conclusion of the 13 weeks of the program
|
Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction. Depressed mood: The Center for Epidemiological Studies Depression Scale for Children (CES-DC) |
At the conclusion of the 13 weeks of the program
|
The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.
Time Frame: At the conclusion of the 13 weeks of the program
|
Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction. Eating behaviors (EAH): Three Factor Eating Questionnaire - R18 |
At the conclusion of the 13 weeks of the program
|
The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.
Time Frame: At the conclusion of the 13 weeks of the program
|
Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction. Pain symptoms: The Pain Frequency - Severity - Duration Scale |
At the conclusion of the 13 weeks of the program
|
The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.
Time Frame: At the conclusion of the 13 weeks of the program
|
Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction. Pain symptoms: The Adolescent Pediatric Pain Tool |
At the conclusion of the 13 weeks of the program
|
The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.
Time Frame: At the conclusion of the 13 weeks of the program
|
Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction. Self-confidence: Readiness Ruler |
At the conclusion of the 13 weeks of the program
|
The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.
Time Frame: At the conclusion of the 13 weeks of the program
|
Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction. Eating behaviors: Eating Behaviors Questionnaire |
At the conclusion of the 13 weeks of the program
|
The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.
Time Frame: At the conclusion of the 13 weeks of the program
|
Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction. Behavior: The Pediatric Symptom Checklist 17 item (PSC-17) |
At the conclusion of the 13 weeks of the program
|
The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.
Time Frame: At the conclusion of the 13 weeks of the program
|
Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction. Quality of life: Sizing me up |
At the conclusion of the 13 weeks of the program
|
The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.
Time Frame: At the conclusion of the 13 weeks of the program
|
Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction. Quality of life: Sizing them up |
At the conclusion of the 13 weeks of the program
|
The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.
Time Frame: At the conclusion of the 13 weeks of the program
|
Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction. Pain symptoms: The Child Activity Limitations Interview questionnaire |
At the conclusion of the 13 weeks of the program
|
The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.
Time Frame: At the conclusion of the 13 weeks of the program
|
Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction. Pain symptoms: The Child Activity Limitations Interview questionnaire Parent version |
At the conclusion of the 13 weeks of the program
|
The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.
Time Frame: At the conclusion of the 13 weeks of the program
|
Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction. Pain symptoms: Pain Burden Interview |
At the conclusion of the 13 weeks of the program
|
The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.
Time Frame: At the conclusion of the 13 weeks of the program
|
Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction. Sleep: Adolescent Sleep-Wake Scale |
At the conclusion of the 13 weeks of the program
|
The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.
Time Frame: At the conclusion of the 13 weeks of the program
|
Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction. Medical: Youth will have their height, weight, BMI and BMI z-score calculated pre and post program completion as well as an assessment of their medical comorbidities. |
At the conclusion of the 13 weeks of the program
|
Collaborators and Investigators
Investigators
- Principal Investigator: Melissa Santos, PhD, Connecticut Children's Medical Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-079
- 1R21DK117221 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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