Trial Outcomes & Findings for Intervention to Reduce Stress in 0-5 Year Olds With Burns (NCT NCT00844896)
NCT ID: NCT00844896
Last Updated: 2014-10-16
Results Overview
Burn Outcomes Questionnaire (American Burn Association/Shriners Hospitals for Children) Short Form (0-4 year old version). Parent-rated questionnaire that focuses on child's pain and parent's worry. Scores range from 5-24, with a higher score indicative of worse outcomes. Change in scores was measured from baseline to six month follow-up
COMPLETED
NA
57 participants
Baseline and six month follow-up
2014-10-16
Participant Flow
Children aged 0-5 years who were hospitalized for an acute or reconstructive burn injury and their families were eligible for participation in the study. Recruitment for the study occurred from May 2008-August 2010.
Participant milestones
| Measure |
DEF-only
Distress Emotional Support and Family Assessment Treatment
|
DEF + COPE
Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
28
|
|
Overall Study
COMPLETED
|
17
|
11
|
|
Overall Study
NOT COMPLETED
|
12
|
17
|
Reasons for withdrawal
| Measure |
DEF-only
Distress Emotional Support and Family Assessment Treatment
|
DEF + COPE
Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
12
|
16
|
|
Overall Study
Parents did not have time to complete
|
0
|
1
|
Baseline Characteristics
Intervention to Reduce Stress in 0-5 Year Olds With Burns
Baseline characteristics by cohort
| Measure |
DEF-only
n=29 Participants
29 subjects in this arm of the study.
|
DEF + COPE
n=28 Participants
28 subjects in this arm of the study.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
1.9 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
2.3 years
STANDARD_DEVIATION 1.6 • n=7 Participants
|
2.1 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
28 participants
n=7 Participants
|
57 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and six month follow-upPopulation: Intention to Treat (ITT)
Burn Outcomes Questionnaire (American Burn Association/Shriners Hospitals for Children) Short Form (0-4 year old version). Parent-rated questionnaire that focuses on child's pain and parent's worry. Scores range from 5-24, with a higher score indicative of worse outcomes. Change in scores was measured from baseline to six month follow-up
Outcome measures
| Measure |
DEF-only
n=13 Participants
Distress Emotional Support and Family Assessment Treatment
|
DEF + COPE
n=6 Participants
Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
|
|---|---|---|
|
Change From Baseline in Burn Outcomes Questionnaire Short Form (0-4 Year Old Version) at Six Months
|
-4.9 units on a scale
Standard Deviation 4.6
|
-4.5 units on a scale
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: Baseline and six month follow-upPopulation: Intention to Treat (ITT)
Pediatric Symptom Checklist is an 18-item psychosocial checklist in which symptoms are rated from 0 (never) to 2 (often) and the last question is rated as yes or no (0 or 1). Items are summed and the score can range from 0-35, with a higher score indicative of more symptoms and a worse outcome. Change in scores were observed from baseline to six month follow-up
Outcome measures
| Measure |
DEF-only
n=5 Participants
Distress Emotional Support and Family Assessment Treatment
|
DEF + COPE
n=2 Participants
Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
|
|---|---|---|
|
Change From Baseline in Pediatric Symptom Checklist at Six Months
|
2.9 units on a scale
Standard Deviation 7.9
|
1.0 units on a scale
Standard Deviation 5.7
|
PRIMARY outcome
Timeframe: Baseline and six month follow-upPopulation: Intention to treat (ITT)
Parenting Stress Index is a 12-item parent-rated questionnaire which employs a 1-5 Likert scale. Scores range from 12-60, with a lower score indicative of worse outcomes and a cutoff of 15. Change in scores were observed from baseline to six month follow-up.
Outcome measures
| Measure |
DEF-only
n=10 Participants
Distress Emotional Support and Family Assessment Treatment
|
DEF + COPE
n=4 Participants
Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
|
|---|---|---|
|
Change From Baseline in Parenting Stress Index at Six Months
|
7.1 units on a scale
Standard Deviation 12.6
|
-3.3 units on a scale
Standard Deviation 9.0
|
PRIMARY outcome
Timeframe: Baseline and six month follow-upPopulation: Intention to treat (ITT)
Child Stress Reaction Checklist Short Form is a 9-item parent-rated checklist. Scores range from 0-18 with a higher score indicative of worse outcomes. Change in scores were observed from baseline to six month follow-up
Outcome measures
| Measure |
DEF-only
n=15 Participants
Distress Emotional Support and Family Assessment Treatment
|
DEF + COPE
n=7 Participants
Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
|
|---|---|---|
|
Change From Baseline in Child Stress Reaction Checklist Short Form at Six Month
|
0.8 units on a scale
Standard Deviation 2.5
|
0.7 units on a scale
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: Baseline and six-month follow-upPopulation: Intention to treat (ITT)
Posttraumatic Stress Disorder Semi-Structured Interview is based on DSM-IV criteria, with a higher score indicative of increased symptoms of PTSD. The total rating was scored from 19 questions in three clusters of symptoms, with a score range of 0-38. Change in scores were observed from baseline to six month follow-up.
Outcome measures
| Measure |
DEF-only
n=12 Participants
Distress Emotional Support and Family Assessment Treatment
|
DEF + COPE
n=6 Participants
Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
|
|---|---|---|
|
Change From Baseline in PTSD Semi-Structured Interview at Six Months
|
-1.7 units on a scale
Standard Deviation 3.1
|
-1.5 units on a scale
Standard Deviation 4.6
|
PRIMARY outcome
Timeframe: Baseline and six-month follow-upPopulation: Intention to treat (ITT)
Hospital Emotional Support Form is a 12-question form that rates parents/caregivers need for in-hospital emotional support. Scores range from 11-24, with a lower score indicative of worse outcomes. Change in scores were observed from baseline to six month follow-up.
Outcome measures
| Measure |
DEF-only
n=16 Participants
Distress Emotional Support and Family Assessment Treatment
|
DEF + COPE
n=7 Participants
Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
|
|---|---|---|
|
Change From Baseline in Hospital Emotional Support Form From Six Months
|
1.1 units on a scale
Standard Deviation 3.8
|
2.0 units on a scale
Standard Deviation 2.6
|
PRIMARY outcome
Timeframe: Baseline and six-month follow-upPopulation: Intention to treat (ITT)
Stanford Acute Stress Reaction Questionnaire is a 31-question self-report measure for acute stress in parents. Scores range from 0-155 with a higher score indicative of worse outcomes. Change in scores were observed from baseline to six month follow-up.
Outcome measures
| Measure |
DEF-only
n=14 Participants
Distress Emotional Support and Family Assessment Treatment
|
DEF + COPE
n=6 Participants
Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
|
|---|---|---|
|
Change From Baseline in Stanford Acute Stress Reaction Questionnaire at Six Months
|
-9.6 units on a scale
Standard Deviation 42.5
|
13.8 units on a scale
Standard Deviation 33.2
|
PRIMARY outcome
Timeframe: BaselinePopulation: Intentional to treat (ITT)
Outcomes in this measure were quantified by the number of participants in either intervention (DEF-only or COPE+DEF). During the study, DEF intervention was part of the standard of care for all patients at Shriners Hospitals for Children-Boston and thus every participant in this study had been evaluated using DEF to determine distress, emotional and family support.
Outcome measures
| Measure |
DEF-only
n=29 Participants
Distress Emotional Support and Family Assessment Treatment
|
DEF + COPE
n=28 Participants
Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
|
|---|---|---|
|
DEF Participation
|
29 participants
|
28 participants
|
PRIMARY outcome
Timeframe: baseline and six month follow-upPopulation: Intention to Treat (ITT)
Burn Outcomes Questionnaire (American Burn Association/Shriners Hospitals for Children) Short Form (5-18 Year Old Version) is a 3-item questionnaire with scores ranging from 0-18. A higher score is indicative of worse outcomes. Used for five year olds in the study. Change in scores were observed from baseline to six month follow-up.
Outcome measures
| Measure |
DEF-only
n=1 Participants
Distress Emotional Support and Family Assessment Treatment
|
DEF + COPE
Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
|
|---|---|---|
|
Change From Baseline in Burn Outcomes Questionnaire Short Form (5-18 Year Old Version) From Six Months.
|
-0.2 units on a scale
Standard Deviation 0.0
|
—
|
Adverse Events
DEF-only
DEF + COPE
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Frederick J. Stoddard Jr., M.D.,
Massachusetts General Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place