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Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury

Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00451282
Enrollment
290
Registered
2007-03-23
Start date
2007-04-30
Completion date
2009-06-30
Last updated
2015-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Disorders, Posttraumatic

Brief summary

This study will evaluate the impact of a brief psychosocial intervention delivered to children or adolescents who are hospitalized for an unintentional injury. The intervention is designed to promote psychological recovery and enhance functional outcomes after injury. The study will also provide preliminary data concerning cost-effectiveness of the intervention. The core study hypotheses are that children receiving the intervention will (1) have lower severity of post-traumatic stress disorder (PTSD) and depression symptoms at follow-up; (2) show greater adherence to discharge instructions and better health-related quality of life at follow-up, and (3) have higher rates of attendance at scheduled follow-up appointments and lower rates of emergency room utilization and re-hospitalization in the 6 months post-injury, compared to those receiving usual care.

Detailed description

The purpose of this study is to examine the effectiveness of a stepped care model for prevention of psychosocial distress (especially posttraumatic stress) after injury. The model includes screening for risk, standard follow-up with those at risk, and additional evidence-based interventions matched to individual need. The study will evaluate the impact of the intervention on psychosocial outcomes (PTSD and depression symptoms); as well as health outcomes (adherence to discharge instructions, health-related quality of life), and will provide preliminary data to inform cost-effectiveness analyses by describing the costs of providing the intervention and examining its impact on subsequent health service utilization. Study Design: 180 children at risk for persistent psychosocial distress post-injury, based on a screening assessment, will be randomized to the Stepped Preventive Care intervention or usual care. An additional comparison group of 90 low risk children will also receive usual care and be followed for assessment.

Interventions

BEHAVIORALstepped preventive care

2 targeted assessments (T1: in hospital within a few days of injury; T2: two weeks post-discharge) are administered by nurse or social worker, and determine need for additional assistance modules. Additional modules include case management, care coordination, assistance with child and family coping with injury/distress, and trauma-focused Cognitive Behavior Therapy (CBT) beginning at 4-6 weeks post-injury if needed.

Sponsors

Centers for Disease Control and Prevention
CollaboratorFED
Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Age 8 to 17 * Admitted to hospital for treatment of unintentional injury * Sufficient English fluency to participate in an interview * Family has access to a telephone (for telephone follow-up contacts)

Exclusion criteria

* Child's medical status or cognitive functioning precludes participating in an interview * Child has moderate to severe head injury, defined as Glasgow Coma Score (GCS) \<= 12 * Child's injury involved family violence or abuse (physical or sexual) * No parent or guardian available to consent

Design outcomes

Primary

MeasureTime frameDescription
PTSD Symptoms in Children 6 Weeks Post-injury6 weeksThe Child PTSD Symptom Scale (CPSS) is a 24-item self-report instrument that yields both a continuous severity score and a determination of likely PTSD diagnostic status according to symptom presence. 17 items corresponding to of the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV symptom criteria (and are assumed to yield a PTSD symptom severity score range 0-51) and 7 items assess impairment from those symptoms. The 17 symptom items were administered at baseline (prerandomization), with a score of 15 or greater considered a positive screen for PTSD risk (higher values represent more significant severity of and impairment from PTSD symptoms). The 24-item scale was administered at 6 weeks and 6 months postinjury to assess traumatic stress symptom outcomes.
PTSD Symptoms in Children 6 Months Post-injury6 monthsThe Child PTSD Symptom Scale (CPSS) is a 24-item self-report instrument that yields both a continuous severity score and a determination of likely PTSD diagnostic status according to symptom presence. 17 items corresponding to DSM-IV symptom criteria (and are assumed to yield a PTSD symptom severity score range 0-51) and 7 items assess impairment from those symptoms. The 17 symptom items were administered at baseline (prerandomization), with a score of 15 or greater considered a positive screen for PTSD risk (higher values represent more significant severity of and impairment from PTSD symptoms). The 24-item scale was administered at 6 weeks and 6 months postinjury to assess traumatic stress symptom outcomes.

Secondary

MeasureTime frameDescription
Health-related Quality of Life 6 Weeks and 6 Months Post-injury6 monthsThe Pediatric Quality of Life Inventory is a well-validated measure of child health-related quality of life. Children completed the measure at baseline to report preinjury functioning and at 6-weeks and 6-months postinjury regarding current functioning. Current analyses utilize the 8-item Physical health/Physical functioning subscale. Scores range from 0-100; higher scores indicate better functioning outcomes.
Depression Symptoms in Children 6 Wks Post-injury6 weeksThe Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report measure of depression symptoms that yields a total severity score (range 0-60) . Clinical cut-off scores (≥16 for adults and ≥24 for youth) have been empirically established. Higher values represent more significant severity of symptoms of depression. The CES-D has been validated in adults and children 10 and over as an effective screen for depression. The CES-D was administered at baseline (prerandomization), 6 weeks and 6 months postinjury.
Health Service Utilization Over the 6 Months Post-injury6 monthsMedical records were used as the primary source of service utilization data; parent report supplemented this information if records were unavailable.
Adherence With Medical Discharge Instructions6 monthsThe Health Care Questionnaire for Parents, created for this study, will assess health services utilized post-injury, adherence with specific discharge instructions (e.g., attendance at recommended follow-up appointments), as well as the number of days missed from work (parent) or school (child) related to the injury. Outcome variables to assess adherence will be dichotomized (e.g., attended scheduled appt? yes / no). The Health Care Questionnaire for Primary Care Physicians (PCPs) will assess primary care providers' contacts with study participants, including whether psychosocial concerns were identified since the injury.
Depression Symptoms in Children 6 Mos Post-injury6 monthsThe Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report measure of depression symptoms that yields a total severity score (range 0-60) . Clinical cut-off scores (≥16 for adults and ≥24 for youth) have been empirically established. Higher values represent more significant severity of symptoms of depression. The CES-D has been validated in adults and children 10 and over as an effective screen for depression. The CES-D was administered at baseline (prerandomization), 6 weeks and 6 months postinjury.

Countries

United States

Participant flow

Recruitment details

Potentially eligible injured patients were identified from patient census and administration lists (n=1330; April 2007 - October 2008). Of 845 eligible children, 149 refused participation, 406 were not approached, usually due to limited parent availability.

Pre-assignment details

290 children were enrolled for risk screening, of these 85 (29%) scored positive on one or more screening measures for PTSD and were randomly assigned to receive usual care or the intervention (n=39 and n=46 respectively). 5 intervention subjects did not end up receiving the allocated intervention.

Participants by arm

ArmCount
Intervention
Injured children receiving Stepped Preventive Care intervention
46
Usual Care
Injured children receiving usual care
39
Total85

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up65

Baseline characteristics

CharacteristicUsual CareInterventionTotal
Age, Categorical
<=18 years
39 Participants46 Participants85 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous11.9 years
STANDARD_DEVIATION 2.7
11.2 years
STANDARD_DEVIATION 2.2
11.5 years
STANDARD_DEVIATION 2.5
Region of Enrollment
United States
39 participants46 participants85 participants
Sex: Female, Male
Female
11 Participants23 Participants34 Participants
Sex: Female, Male
Male
28 Participants23 Participants51 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 460 / 39
serious
Total, serious adverse events
0 / 460 / 39

Outcome results

Primary

PTSD Symptoms in Children 6 Months Post-injury

The Child PTSD Symptom Scale (CPSS) is a 24-item self-report instrument that yields both a continuous severity score and a determination of likely PTSD diagnostic status according to symptom presence. 17 items corresponding to DSM-IV symptom criteria (and are assumed to yield a PTSD symptom severity score range 0-51) and 7 items assess impairment from those symptoms. The 17 symptom items were administered at baseline (prerandomization), with a score of 15 or greater considered a positive screen for PTSD risk (higher values represent more significant severity of and impairment from PTSD symptoms). The 24-item scale was administered at 6 weeks and 6 months postinjury to assess traumatic stress symptom outcomes.

Time frame: 6 months

Population: 85 children were randomly assigned to receive usual care (n=39) or the intervention (n=46, 5 did not go on to receive intervention). Of these subjects, 31 usual care subjects and 37 intervention subjects completed 6 month follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionPTSD Symptoms in Children 6 Months Post-injury12.6 Units on a scaleStandard Deviation 11.6
Usual CarePTSD Symptoms in Children 6 Months Post-injury12.2 Units on a scaleStandard Deviation 9.7
p-value: 0.89t-test, 2 sided
Primary

PTSD Symptoms in Children 6 Weeks Post-injury

The Child PTSD Symptom Scale (CPSS) is a 24-item self-report instrument that yields both a continuous severity score and a determination of likely PTSD diagnostic status according to symptom presence. 17 items corresponding to of the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV symptom criteria (and are assumed to yield a PTSD symptom severity score range 0-51) and 7 items assess impairment from those symptoms. The 17 symptom items were administered at baseline (prerandomization), with a score of 15 or greater considered a positive screen for PTSD risk (higher values represent more significant severity of and impairment from PTSD symptoms). The 24-item scale was administered at 6 weeks and 6 months postinjury to assess traumatic stress symptom outcomes.

Time frame: 6 weeks

Population: 85 children were randomly assigned to receive usual care (n=39) or the intervention (n=46, 5 did not go on to receive intervention). Of these subjects, 28 usual care subjects and 36 intervention subjects completed 6 week follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionPTSD Symptoms in Children 6 Weeks Post-injury12.6 Units on a scaleStandard Deviation 10.2
Usual CarePTSD Symptoms in Children 6 Weeks Post-injury13.6 Units on a scaleStandard Deviation 10.7
p-value: 0.69t-test, 2 sided
Secondary

Adherence With Medical Discharge Instructions

The Health Care Questionnaire for Parents, created for this study, will assess health services utilized post-injury, adherence with specific discharge instructions (e.g., attendance at recommended follow-up appointments), as well as the number of days missed from work (parent) or school (child) related to the injury. Outcome variables to assess adherence will be dichotomized (e.g., attended scheduled appt? yes / no). The Health Care Questionnaire for Primary Care Physicians (PCPs) will assess primary care providers' contacts with study participants, including whether psychosocial concerns were identified since the injury.

Time frame: 6 months

Secondary

Depression Symptoms in Children 6 Mos Post-injury

The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report measure of depression symptoms that yields a total severity score (range 0-60) . Clinical cut-off scores (≥16 for adults and ≥24 for youth) have been empirically established. Higher values represent more significant severity of symptoms of depression. The CES-D has been validated in adults and children 10 and over as an effective screen for depression. The CES-D was administered at baseline (prerandomization), 6 weeks and 6 months postinjury.

Time frame: 6 months

Population: 85 children were randomly assigned to receive usual care (n=39) or the intervention (n=46, 5 did not go on to receive intervention). Of these subjects, 31 usual care subjects and 37 intervention subjects completed 6 week follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionDepression Symptoms in Children 6 Mos Post-injury15.6 Units on a scaleStandard Deviation 13.8
Usual CareDepression Symptoms in Children 6 Mos Post-injury11.6 Units on a scaleStandard Deviation 9.9
p-value: 0.18t-test, 2 sided
Secondary

Depression Symptoms in Children 6 Wks Post-injury

The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report measure of depression symptoms that yields a total severity score (range 0-60) . Clinical cut-off scores (≥16 for adults and ≥24 for youth) have been empirically established. Higher values represent more significant severity of symptoms of depression. The CES-D has been validated in adults and children 10 and over as an effective screen for depression. The CES-D was administered at baseline (prerandomization), 6 weeks and 6 months postinjury.

Time frame: 6 weeks

Population: 85 children were randomly assigned to receive usual care (n=39) or the intervention (n=46, 5 did not go on to receive intervention). Of these subjects, 28 usual care subjects and 36 intervention subjects completed 6 week follow-up.

ArmMeasureValue (MEAN)Dispersion
InterventionDepression Symptoms in Children 6 Wks Post-injury15.0 Units on a scaleStandard Deviation 10.7
Usual CareDepression Symptoms in Children 6 Wks Post-injury14.0 Units on a scaleStandard Deviation 10.8
p-value: 0.69t-test, 2 sided
Secondary

Health-related Quality of Life 6 Weeks and 6 Months Post-injury

The Pediatric Quality of Life Inventory is a well-validated measure of child health-related quality of life. Children completed the measure at baseline to report preinjury functioning and at 6-weeks and 6-months postinjury regarding current functioning. Current analyses utilize the 8-item Physical health/Physical functioning subscale. Scores range from 0-100; higher scores indicate better functioning outcomes.

Time frame: 6 months

Secondary

Health Service Utilization Over the 6 Months Post-injury

Medical records were used as the primary source of service utilization data; parent report supplemented this information if records were unavailable.

Time frame: 6 months

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026