Trial Outcomes & Findings for Recovery After Stress Toolkit (RESET) Study (NCT NCT04838977)
NCT ID: NCT04838977
Last Updated: 2025-08-28
Results Overview
17 items listing potential PTSD symptoms scored on a Likert scale of 0 to 3 with 0=Not at all and 3= 5 or more times a week. 7 additional yes/no questions ask if problems interfered with various activities. Higher score is worse. Range 0 to 80. We used the combined child report and parent report. The highest item score from either parent or child was summed.
COMPLETED
NA
93 participants
10 weeks post-randomization
2025-08-28
Participant Flow
93 children randomized
130 children eligible for randomization No consent obtained = 37 Reasons: Currently receiving psychotherapy (exclusion criteria), n=5 Parent felt too much time required, n=6 Participant no longer interested, n=9 No reason given/unknown, n=8 Other reason, n=9
Participant milestones
| Measure |
RESET
Children will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth.
|
Control
Children will receive usual post-trauma care.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
46
|
|
Overall Study
COMPLETED
|
44
|
42
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
RESET
Children will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth.
|
Control
Children will receive usual post-trauma care.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Recovery After Stress Toolkit (RESET) Study
Baseline characteristics by cohort
| Measure |
RESET
n=47 Participants
Children will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth.
RESET: Therapy
|
Control
n=46 Participants
Children will receive usual post-trauma care.
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
47 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
93 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
|
11.6 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
11.7 years
STANDARD_DEVIATION 2.5 • n=7 Participants
|
11.65 years
STANDARD_DEVIATION 2.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
47 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
CPSS
|
22.7 CPSS score
STANDARD_DEVIATION 9.4 • n=5 Participants
|
23.7 CPSS score
STANDARD_DEVIATION 8.6 • n=7 Participants
|
23.2 CPSS score
STANDARD_DEVIATION 9.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeks post-randomizationPopulation: We had 3 children not complete the intervention and 4 controls not complete the final data collection as shown in participant flow.
17 items listing potential PTSD symptoms scored on a Likert scale of 0 to 3 with 0=Not at all and 3= 5 or more times a week. 7 additional yes/no questions ask if problems interfered with various activities. Higher score is worse. Range 0 to 80. We used the combined child report and parent report. The highest item score from either parent or child was summed.
Outcome measures
| Measure |
RESET
n=44 Participants
Children will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth.
|
Control
n=42 Participants
Children will receive usual post-trauma care.
|
|---|---|---|
|
Child PTSD Symptom Scale (CPSS)
|
10.4 Score on a scale
Standard Deviation 8.5
|
14 Score on a scale
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: 10 weeks post-randomizationPopulation: Some participants did not complete the measure.
41-item survey with three point Likert scale responses (not sure, somewhat true, very true) that asks about common difficulties for children with anxiety. Higher scores indicate worse outcomes. Range 0-82
Outcome measures
| Measure |
RESET
n=38 Participants
Children will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth.
|
Control
n=33 Participants
Children will receive usual post-trauma care.
|
|---|---|---|
|
Screen for Anxiety Related Emotional Disorders (SCARED)
|
12.6 Score on a scale
Standard Deviation 12.4
|
20.8 Score on a scale
Standard Deviation 14.7
|
SECONDARY outcome
Timeframe: 10-weeks post-randomizationPROMIS pediatric item bank : 8 questions with a 5-point Likert response from Never to Almost Always. Higher scores means more depressive symptoms. T-score with mean = 50; Standard Deviation (SD)=10.
Outcome measures
| Measure |
RESET
n=42 Participants
Children will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth.
|
Control
n=42 Participants
Children will receive usual post-trauma care.
|
|---|---|---|
|
Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Depressive Symptoms
|
42.9 Score on a scale
Standard Deviation 9.0
|
49.8 Score on a scale
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: 10-weeksPopulation: Some participants did not complete all scales.
15 question scale based on physical, emotional, social and school functioning answered on a 5-point Likert scale (never to almost always). Score is 0 - 100 with higher scores indicating better HRQoL. Parent proxy scale.
Outcome measures
| Measure |
RESET
n=43 Participants
Children will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth.
|
Control
n=40 Participants
Children will receive usual post-trauma care.
|
|---|---|---|
|
Pediatric Quality of Life Inventory (PedsQL)
|
71.4 Score on a scale
Standard Deviation 16.7
|
68.4 Score on a scale
Standard Deviation 17.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 10-weeks10-item scale with LIkert response from 0 - not true to 4=true nearly all of the time. Range is 0 to 40 with higher scores indicating more resilience (better).
Outcome measures
| Measure |
RESET
n=40 Participants
Children will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth.
|
Control
n=41 Participants
Children will receive usual post-trauma care.
|
|---|---|---|
|
Connor David Resilience Scale
|
26.8 Score on a scale
Standard Deviation 12.1
|
21.4 Score on a scale
Standard Deviation 10.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 10-weeks post-randomization5 question PROMIS measure answered with a 5-point Likert scale. A higher score indicates more anger (worse). T-score with mean = 50; SD = 10.
Outcome measures
| Measure |
RESET
n=42 Participants
Children will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth.
|
Control
n=42 Participants
Children will receive usual post-trauma care.
|
|---|---|---|
|
PROMIS Pediatric Anger
|
43.6 Score on a scale
Standard Deviation 11.3
|
47.9 Score on a scale
Standard Deviation 11.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 10-weeks post-randomizationPopulation: Not all children completed all measures.
8-question PROMIS measure answered with a 5-point Likert scale. A higher score is more stress (worse). T-score with mean 50; SD 10.
Outcome measures
| Measure |
RESET
n=42 Participants
Children will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth.
|
Control
n=42 Participants
Children will receive usual post-trauma care.
|
|---|---|---|
|
PROMIS Pediatric Psychological Stress Experience
|
47.1 Score on a scale
Standard Deviation 9.8
|
54.2 Score on a scale
Standard Deviation 10.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 10-weeksPopulation: Not all children completed all of the measures.
8-question PROMIS measure answered on a 5-point Likert scale. A higher score is more physical stress (worse). T-score with mean 50; SD 10.
Outcome measures
| Measure |
RESET
n=42 Participants
Children will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth.
|
Control
n=42 Participants
Children will receive usual post-trauma care.
|
|---|---|---|
|
PROMIS Pediatric Physical Stress Experience
|
47.4 Score on a scale
Standard Deviation 9.6
|
53.3 Score on a scale
Standard Deviation 9.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 10-weeksPopulation: Not all children completed all of the measures.
8-question PROMIS measure answered on a 5-point LIkert scale. A higher score is more anxiety (worse). T-score with mean 50; SD 10.
Outcome measures
| Measure |
RESET
n=42 Participants
Children will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth.
|
Control
n=42 Participants
Children will receive usual post-trauma care.
|
|---|---|---|
|
PROMIS Pediatric Anxiety
|
42.7 Score on a scale
Standard Deviation 11.2
|
47.5 Score on a scale
Standard Deviation 11.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 10-weeksPopulation: Not all children completed all of the measures.
Seven questions about global health with 5-point Likert response from excellent to poor. A higher score is more poor health (worse). T-score with mean 50; SD 10.
Outcome measures
| Measure |
RESET
n=42 Participants
Children will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth.
|
Control
n=42 Participants
Children will receive usual post-trauma care.
|
|---|---|---|
|
PROMIS Pediatric Global Health
|
51.0 Score on a scale
Standard Deviation 9.9
|
47 Score on a scale
Standard Deviation 10.7
|
Adverse Events
Control
RESET
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place