Post-Traumatic Stress Disorder in Adolescence, Post-Traumatic Stress Disorder in Children
Conditions
Brief summary
This study evaluates the use of web-based educational modules combined with telehealth delivered therapy for children with post-traumatic stress symptoms (PTSS) after receiving hospital based medical attention for an injury. Half of the participants will received the online therapy and half of the participants will receive usual care.
Detailed description
As many as 30% of children develop post-traumatic stress symptoms after an injury. Post-traumatic stress symptoms can decrease children's quality of life. Psychological distress may emerge after the child is discharged from the hospital and may go unrecognized. Cognitive behavioral therapy and graduated exposures are standard treatments for PTSS.
Interventions
BEHAVIORALRESET
Therapy
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Investigators will not be aware of study assignment.
Intervention model description
Study comparing treatment to usual care.
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 8 years to 17 years at enrollment * Treated for an injury in the ED or hospitalized * Abbreviated Injury Scale (AIS) score 2 or greater * Parent and child English speaking * Broad band internet availability at home * Residing with parent or legal guardian
Exclusion criteria
* Moderate or severe traumatic brain injury (GCS less than 13) * Diagnosed with moderate or severe intellectual disability * Pre-existing psychiatric disorder that required hospitalization * Abuse or interpersonal injury as mechanism of injury * Currently receiving psychotherapy * Hospitalized for injury over 30 ays * Death of a family member or friend at time of injury
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child PTSD Symptom Scale (CPSS) | 10 weeks post-randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Screen for Anxiety Related Emotional Disorders (SCARED) | 10 weeks post-randomization | 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 |
| Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Depressive Symptoms | 10-weeks post-randomization | PROMIS 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. |
| Pediatric Quality of Life Inventory (PedsQL) | 10-weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Pediatric Anxiety | 10-weeks | 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. |
| Connor David Resilience Scale | 10-weeks | 10-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). |
| PROMIS Pediatric Global Health | 10-weeks | 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. |
| PROMIS Pediatric Anger | 10-weeks post-randomization | 5 question PROMIS measure answered with a 5-point Likert scale. A higher score indicates more anger (worse). T-score with mean = 50; SD = 10. |
| PROMIS Pediatric Psychological Stress Experience | 10-weeks post-randomization | 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. |
| PROMIS Pediatric Physical Stress Experience | 10-weeks | 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. |
Countries
United States
Participant flow
Recruitment details
93 children randomized
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| RESET Children will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth.
RESET: Therapy | 47 |
| Control Children will receive usual post-trauma care. | 46 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | RESET | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 47 Participants | 46 Participants | 93 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 11.6 years STANDARD_DEVIATION 2.4 | 11.7 years STANDARD_DEVIATION 2.5 | 11.65 years STANDARD_DEVIATION 2.43 |
| CPSS | 22.7 CPSS score STANDARD_DEVIATION 9.4 | 23.7 CPSS score STANDARD_DEVIATION 8.6 | 23.2 CPSS score STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 17 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 29 Participants | 66 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 5 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 35 Participants | 37 Participants | 72 Participants |
| Region of Enrollment United States | 47 Participants | 46 Participants | 93 Participants |
| Sex: Female, Male Female | 15 Participants | 22 Participants | 37 Participants |
| Sex: Female, Male Male | 32 Participants | 24 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 47 |
| other Total, other adverse events | 0 / 46 | 0 / 47 |
| serious Total, serious adverse events | 0 / 46 | 0 / 47 |
Outcome results
Primary
Child PTSD Symptom Scale (CPSS)
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.
Time frame: 10 weeks post-randomization
Population: We had 3 children not complete the intervention and 4 controls not complete the final data collection as shown in participant flow.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RESET | Child PTSD Symptom Scale (CPSS) | 10.4 Score on a scale | Standard Deviation 8.5 |
| Control | Child PTSD Symptom Scale (CPSS) | 14 Score on a scale | Standard Deviation 9.5 |
Comparison: The null hypothesis is there is no difference in mean CPSS at 10 weeks in the intervention group versus the control group.95% CI: [-7.6, -0.8]
Secondary
Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Depressive Symptoms
PROMIS 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.
Time frame: 10-weeks post-randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RESET | Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Depressive Symptoms | 42.9 Score on a scale | Standard Deviation 9 |
| Control | Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Depressive Symptoms | 49.8 Score on a scale | Standard Deviation 10.9 |
Secondary
Pediatric Quality of Life Inventory (PedsQL)
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.
Time frame: 10-weeks
Population: Some participants did not complete all scales.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RESET | Pediatric Quality of Life Inventory (PedsQL) | 71.4 Score on a scale | Standard Deviation 16.7 |
| Control | Pediatric Quality of Life Inventory (PedsQL) | 68.4 Score on a scale | Standard Deviation 17.2 |
Secondary
Screen for Anxiety Related Emotional Disorders (SCARED)
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
Time frame: 10 weeks post-randomization
Population: Some participants did not complete the measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RESET | Screen for Anxiety Related Emotional Disorders (SCARED) | 12.6 Score on a scale | Standard Deviation 12.4 |
| Control | Screen for Anxiety Related Emotional Disorders (SCARED) | 20.8 Score on a scale | Standard Deviation 14.7 |
Other Pre-specified
Connor David Resilience Scale
10-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).
Time frame: 10-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RESET | Connor David Resilience Scale | 26.8 Score on a scale | Standard Deviation 12.1 |
| Control | Connor David Resilience Scale | 21.4 Score on a scale | Standard Deviation 10.5 |
Other Pre-specified
PROMIS Pediatric Anger
5 question PROMIS measure answered with a 5-point Likert scale. A higher score indicates more anger (worse). T-score with mean = 50; SD = 10.
Time frame: 10-weeks post-randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RESET | PROMIS Pediatric Anger | 43.6 Score on a scale | Standard Deviation 11.3 |
| Control | PROMIS Pediatric Anger | 47.9 Score on a scale | Standard Deviation 11.9 |
Other Pre-specified
PROMIS Pediatric Anxiety
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.
Time frame: 10-weeks
Population: Not all children completed all of the measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RESET | PROMIS Pediatric Anxiety | 42.7 Score on a scale | Standard Deviation 11.2 |
| Control | PROMIS Pediatric Anxiety | 47.5 Score on a scale | Standard Deviation 11.1 |
Other Pre-specified
PROMIS Pediatric Global Health
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.
Time frame: 10-weeks
Population: Not all children completed all of the measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RESET | PROMIS Pediatric Global Health | 51.0 Score on a scale | Standard Deviation 9.9 |
| Control | PROMIS Pediatric Global Health | 47 Score on a scale | Standard Deviation 10.7 |
Other Pre-specified
PROMIS Pediatric Physical Stress Experience
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.
Time frame: 10-weeks
Population: Not all children completed all of the measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RESET | PROMIS Pediatric Physical Stress Experience | 47.4 Score on a scale | Standard Deviation 9.6 |
| Control | PROMIS Pediatric Physical Stress Experience | 53.3 Score on a scale | Standard Deviation 9.7 |
Other Pre-specified
PROMIS Pediatric Psychological Stress Experience
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.
Time frame: 10-weeks post-randomization
Population: Not all children completed all measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RESET | PROMIS Pediatric Psychological Stress Experience | 47.1 Score on a scale | Standard Deviation 9.8 |
| Control | PROMIS Pediatric Psychological Stress Experience | 54.2 Score on a scale | Standard Deviation 10.8 |