Stress Disorders, PosttraumaticPhase 3NCT00451282

Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury

A Phase 3 study testing stepped preventive care in people with Stress Disorders, Posttraumatic, run by Children's Hospital of Philadelphia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 8 to 17 years
Conditions the study is for: Stress Disorders, Posttraumatic
What is being tested?: stepped preventive care
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 290 participants
Where: 1 siteUnited States
Study dates: Apr 2007to Jun 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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.

Read the 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.

Conditions: Stress Disorders, Posttraumatic
Being tested: stepped preventive care
Medical subject headings: Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

stepped preventive careBehavioural
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.

Study groups in NCT00451282
Study group	Role	What they receive
Stepped Preventive Care	Experimental	Receiving Stepped Preventive Care intervention - at least 2 brief assessments with nurse and/or social worker (1) during hospital admission , and (2) approximately 2 weeks post-discharge. Additional interventions provided as needed, based on manual. Receives: Behavioral: stepped preventive care
Treatment as usual	No intervention	Medical and psychosocial care per usual hospital protocols, which may include social work support.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 weeks
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.
Measured: 6 months

Secondary outcomes (5)

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.
Measured: 6 weeks
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2007Jun 2009

First posted23 Mar 2007 (estimated)
Study startApr 2007
Primary completionJun 2009
Study completionJun 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Stress Disorders, PosttraumaticStudies of the same condition, open and under way.
More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 290 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00451282
Sponsor's protocol ID: 2006-9-4974
Other IDs: R49CE000987-01
Status last verified: Apr 2015
First submitted: 22 Mar 2007
Last updated: 20 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Kassam-Adams N, Garcia-Espana JF, Marsac ML, Kohser KL, Baxt C, Nance M, Winston F. A pilot randomized controlled trial assessing secondary prevention of traumatic stress integrated into pediatric trauma care. J Trauma Stress. 2011 Jun;24(3):252-9. doi: 10.1002/jts.20640. Epub 2011 May 18.
PubMed 21594900

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury
ClinicalTrials.gov ID: NCT00451282
Acronym / sponsor ID: 2006-9-4974
Conditions: Stress Disorders, Posttraumatic
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 290 participants (actual)
Lead sponsor: Children's Hospital of PhiladelphiaUniversity, hospital or other
Collaborators: Centers for Disease Control and Prevention
Study start: Apr 2007
Primary completion: Jun 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 23 Mar 2007 (estimated)
Results: Posted 20 Apr 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Stepped Preventive Care	Experimental	Behavioral: stepped preventive careReceiving Stepped Preventive Care intervention - at least 2 brief assessments with nurse and/or social worker (1) during hospital admission , and (2) approximately 2 weeks post-discharge. Additional interventions provided as needed, based on manual.
Treatment as usual	No intervention	–Medical and psychosocial care per usual hospital protocols, which may include social work support.

Who may qualify

Ages: 8 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
stepped preventive care2 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.	Behavioural	Stepped Preventive Care

Primary outcome

PTSD Symptoms in Children 6 Weeks Post-injury
Time frame: 6 weeks
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.
PTSD Symptoms in Children 6 Months Post-injury
Time frame: 6 months
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.

5 secondary outcomes

Depression Symptoms in Children 6 Wks Post-injury
Time frame: 6 weeks
Depression Symptoms in Children 6 Mos Post-injury
Time frame: 6 months
Health-related Quality of Life 6 Weeks and 6 Months Post-injury
Time frame: 6 months
Adherence With Medical Discharge Instructions
Time frame: 6 months
Health Service Utilization Over the 6 Months Post-injury
Time frame: 6 months

Results and safety

Results posted to the registry on 20 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	46	40
Usual Care	39	34

Primary outcome: PTSD Symptoms in Children 6 Weeks Post-injury

Time frame: 6 weeks. Mean (Standard Deviation). Unit: Units on a scale

Measure	Intervention n = 36	Usual Care n = 28
Value	12.6 (10.2)	13.6 (10.7)

Intervention vs Usual Care: p = .69, t-test, 2 sided

Population analysed: 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.

Primary outcome: PTSD Symptoms in Children 6 Months Post-injury

Time frame: 6 months. Mean (Standard Deviation). Unit: Units on a scale

Measure	Intervention n = 37	Usual Care n = 31
Value	12.6 (11.6)	12.2 (9.7)

Intervention vs Usual Care: p = .89, t-test, 2 sided

Population analysed: 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.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 46 (0%)	0 of 46 (0%)	Not reported
Usual Care	0 of 39 (0%)	0 of 39 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21594900Kassam-Adams N, Garcia-Espana JF, Marsac ML, Kohser KL, Baxt C, Nance M, Winston F. A pilot randomized controlled trial assessing secondary prevention of traumatic stress integrated into pediatric trauma care. J Trauma Stress. 2011 Jun;24(3):252-9. doi: 10.1002/jts.20640. Epub 2011 May 18.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nancy Kassam-Adams, PhD principal investigator

Center for Injury Research and Prevention, Children's Hospital of Philadelphia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing stepped preventive care in people with Stress Disorders, Posttraumatic, run by Children's Hospital of Philadelphia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PTSD Symptoms in Children 6 Weeks Post-injury (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00451282, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2015.