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Addressing Traumatic Stress Symptoms in Children

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ClinicalTrials.gov Identifier: NCT03334942
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : April 9, 2020
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Drexel University
University of Colorado, Denver
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief Summary:
The objective of this study is to evaluate the effectiveness of the Child and Family Traumatic Stress Intervention (CFTSI), provided soon after a violent traumatic event, in producing significant and sustained reduction in PTSS among assault injured youth.

Condition or disease Intervention/treatment Phase
Violence, Non-accidental Posttraumatic Stress Disorder Parent-Child Relations Assault Youth Behavioral: Child and Family Traumatic Stress Intervention Not Applicable

Detailed Description:

Interventions to target modifiable risk and protective factors during the early post-trauma period may promote recovery and reduce posttraumatic stress symptoms (PTSS) following violent injury by facilitating cognitive and emotional processing of trauma reactions, increasing coping capacity, and providing emotional support.

Investigators seek to evaluate the effectiveness of the Child and Family Traumatic Stress Intervention (CFTSI), provided soon after a violent traumatic event, in producing significant and sustained reduction in PTSS among assault injured youth.

Participants will be recruited from Children's Hospital of Philadelphia (CHOP) emergency department (ED) or Trauma Unit following interpersonal assault. Investigators seek to enroll 300 participants from CHOP. Participants must reside in Philadelphia County with a caregiver for at least the last six months, be 8 to 18 years of age (inclusive), have been received for an injury resulting from a qualifying interpersonal assault, and both child and caregiver must be able to speak English. Youth must have a Child Post-traumatic stress disorder (PTSD) Symptom Scale (CPSS) score > or = 11 during study screening.The Child and Family Traumatic Stress Intervention (CFTSI) is the study intervention. The primary outcome measure is youth-reported PTSS at 4 and 10 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Research assistants (RAs) will perform eligibility screening in the CHOP ED or Trauma Unit on potentially eligible youth and their caregivers who present for care following an assault-related injury. For individuals discharged before being screened, RAs will phone them within 14 days of discharge for screening. Consented youth and caregivers will complete baseline study assessments followed by random assignment to either the intervention [Violence Intervention Program (VIP) with Child and Family Traumatic Stress Intervention (CFTSI)] or control (VIP-only) conditions. VIP is the standard of care provided to assault injured youth treated in the CHOP ED or Trauma Unit. The study coordinator or VIP staff member will notify youth of their assigned condition. CFTSI clinicians will schedule intervention sessions with the families in community-based mental health centers. RAs will be blinded to participant condition and administer baseline and follow-up assessments to all participants.
Masking: Single (Outcomes Assessor)
Masking Description: Only the study coordinator and VIP staff members will be aware of a participant's randomization assignment. The study research assistants (RAs), who will be responsible for administering baseline, 4-month, and 10-month assessments will be blinded to the participant's study condition throughout the duration of the study.
Primary Purpose: Treatment
Official Title: Addressing Community Violence-related Traumatic Stress Symptoms in Children
Actual Study Start Date : November 2, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : May 31, 2022

Arm Intervention/treatment
Experimental: CFTSI
Youth and caregivers randomized to the Violence Intervention Program (VIP) and Child and Family Traumatic Stress Intervention (CFTSI) arm will receive 5 to 8 CFTSI sessions with a trained clinician and be enrolled in VIP. VIP is the standard clinical service offered to assault injured patients treated in the CHOP ED. Participants in this arm will also complete follow-up assessments approximately 4 and 10 months following the ED visit.
Behavioral: Child and Family Traumatic Stress Intervention
The Child and Family Traumatic Stress Intervention (CFTSI) is a 5-8 session intervention, initiated within 60 days of trauma exposure for youth reporting acute PTSS. CFTSI is designed for children age 7 and older, and requires the involvement of a caregiver who knows the child well enough to report changes in the child's behavior and symptoms. CFTSI targets modifiable risk and protective factors during the early post-trauma period to promote recovery and reduce PTSS via caregiver-child communication and cognitive and emotional processing. CFTSI uses skill modules (e.g., sleep disturbance, intrusive thoughts, anxiety) to teach effective strategies to decrease a child's PTSS. Coping and communication skills are taught and practiced in caregiver-child sessions and in the home.
Other Name: CFTSI

No Intervention: Violence Intervention Program
Youth and caregivers randomized to the VIP-only condition will complete a baseline assessment prior to randomization and then be enrolled in the Violence Intervention Program (VIP). VIP is the standard clinical service offered to assault injured patients treated in the CHOP ED. Participants in this arm will also complete follow-up assessments approximately 4 and 10 months following the ED visit.



Primary Outcome Measures :
  1. Change in Child PTSD Symptom Scale (CPSS-5) score from baseline to 4 months post-ED visit. [ Time Frame: 4 months ]
    Assesses the severity of posttraumatic stress symptoms in youth ages 8 to 18 years old. Items correspond to DSM-5 PTSD symptom criteria. Symptom items are rated on a Likert-type scale (0-1-2-3-4) corresponding to "not at all" to "6 or more times a week/almost always." The CPSS yields a symptom severity score (sum of responses) and can be scored for possible PTSD diagnosis. Possible CPSS-5 scores range from 0 to 80. Based on the current evidence regarding screening for PTSD risk, we will employ a screening cut-off (greater than or equal to 11) on the summed CPSS severity score from 20 symptom items, indicating moderate PTSS.


Secondary Outcome Measures :
  1. Change in Revised Children's Anxiety and Depression Scale (RCADS) short form score from baseline to 4 months post-ED visit [ Time Frame: 4 months ]
    Items assess a youth's self-reported anxiety and depression. Response options range from "never" to "always". Item responses are summed to create an RCADS total score with higher scores indicating greater frequency of anxiety and low mood. Possible scores on the short form range from 0 to 75.

  2. Change in Revised Children's Anxiety and Depression Scale (RCADS) short form score from baseline to 10 months post-ED visit [ Time Frame: 10 months ]
    Items assess a youth's self-reported anxiety and depression. Response options range from "never" to "always". Item responses are summed to create an RCADS total score with higher scores indicating greater frequency of anxiety and low mood. Possible scores on the short form range from 0 to 75.

  3. Change in self-reported substance use as assessed by Behavioral Health Screen (BHS) items from baseline to 4 months post-ED visit [ Time Frame: 4 months ]
    Assesses use of alcohol and illicit drugs in participants 12 years of age and older.

  4. Change in self-reported substance use as assessed by Behavioral Health Screen (BHS) items from baseline to 10 months post-ED visit [ Time Frame: 10 months ]
    Assesses use of alcohol and illicit drugs in participants 12 years of age and older.

  5. Change in Strengths and Difficulties Questionnaire-Child and Parent Report (SDQ & SDQ-P) from baseline to 4 months post-ED visit [ Time Frame: 4 months ]
    The SDQ and SDQ-P assess externalizing and internalizing problem areas (conduct problems, hyperactivity/inattention, emotional symptoms, peer problems) as well as pro-social behavior in youth. The measure has age-tailored parent- and self-report versions, with two questions assessing intervention change. Items are scored as "not true", "somewhat true", or "certainly true." The first four problem subscales (emotional symptoms, conduct problems, hyperactivity-inattention, peer problems) are summed to create a Total Difficulties scale score ranging from 0 to 40. Higher scores on the difficulties subscales and Total Difficulties scale correspond to higher levels of difficulty. Higher scores on the prosocial behavior scale indicate higher levels of strengths.

  6. Change in Strengths and Difficulties Questionnaire-Child and Parent Report (SDQ & SDQ-P) from baseline to 10 months post-ED visit [ Time Frame: 10 months ]
    The SDQ and SDQ-P assess externalizing and internalizing problem areas (conduct problems, hyperactivity/inattention, emotional symptoms, peer problems) as well as pro-social behavior in youth. The measure has age-tailored parent- and self-report versions, with two questions assessing intervention change. Items are scored as "not true", "somewhat true", or "certainly true." The first four problem subscales (emotional symptoms, conduct problems, hyperactivity-inattention, peer problems) are summed to create a Total Difficulties scale score ranging from 0 to 40. Higher scores on the difficulties subscales and Total Difficulties scale correspond to higher levels of difficulty. Higher scores on the prosocial behavior scale indicate higher levels of strengths.

  7. Change in Child PTSD Symptom Scale (CPSS-5) score from baseline to 10 months post-ED visit. [ Time Frame: 10 months ]
    Assesses the severity of posttraumatic stress symptoms in youth ages 8 to 18 years old. Items correspond to DSM-5 PTSD symptom criteria. Symptom items are rated on a Likert-type scale (0-1-2-3-4) corresponding to "not at all" to "6 or more times a week/almost always." The CPSS yields a symptom severity score (sum of responses) and can be scored for possible PTSD diagnosis. Possible CPSS-5 scores range from 0 to 80. Based on the current evidence regarding screening for PTSD risk, we will employ a screening cut-off (greater than or equal to 11) on the summed CPSS severity score from 20 symptom items, indicating moderate PTSS.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria for youth participants

    1. Males or females age 8 to 18 years (inclusive)
    2. Received treatment in the CHOP ED or trauma unit for an injury resulting from a qualifying interpersonal assault
    3. Child must be able to speak English well enough to participate in study activities
    4. Child must reside in Philadelphia County (191xx zip code)
    5. Identifies a consistent caregiver for at least the past 6 months. This may include a parent, legal guardian, or another adult (e.g. grandparent, adult sibling, aunt/uncle, etc.).
    6. Child PTSD Symptom Scale (CPSS) score > or = 11 in ED or on screening telephone call
    7. Parental/guardian permission (informed consent) and child assent
  • Inclusion criteria for adult participants

    1. Parent, legal guardian, or other caregiver of an eligible youth participant. Other caregivers may include non-legal guardians who meet all other study eligibility requirements and have approval of the participating child's parent/legal guardian to participate in study activities.
    2. Adult must be able to speak English well enough to participate in study activities
    3. Adult is youth's consistent caregiver for at least the past 6 months
    4. Provide permission (informed consent) to participate in study activities. When a caregiver who is a non-legal guardian is identified to be primary caregiver and meet all other eligibility requirements, parental consent will be obtained for child participation in addition to non-legal guardian consent for self-participation.

Exclusion Criteria:

  • Exclusion criteria for youth participants

    1. Age younger than 8 or older than 18 years
    2. Youth who is non-English speaking or for other reasons is unable to understand and answer study questions and participate in study activities
    3. Youth hospitalized for greater than 14 days (unable to achieve timely study enrollment)
    4. No long-term (< 6 months) caregiver
    5. Index injury in the ED due to family violence (assaulted by a parent, sibling, or other family/household member), sexual assault, or fights with police, security, or school personnel
    6. In residential placement at time of ED visit
    7. Parent or legal guardian unable to provide consent for youth participation.
  • Exclusion criteria for adult participants

    1. Not a primary or consistent caregiver for eligible youth for at least 6 months
    2. Adult who is non-English speaking or for other reasons is unable to understand and answer study questions and participate in study activities
    3. Unable or unwilling to participate in CFTSI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334942


Contacts
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Contact: Joel Fein, MD 215-590-1944 Fein@email.chop.edu
Contact: Rachel K Myers, PhD 267-425-0393 Myersr@email.chop.edu

Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19146
Contact: Joel Fein, MD, MPH    215-590-1944    Fein@email.chop.edu   
Contact: Rachel K Myers, PhD    267-425-0393    Myersr@email.chop.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Drexel University
University of Colorado, Denver
Investigators
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Principal Investigator: Joel Fein, MD, MPH Children's Hospital of Philadelphia
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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03334942    
Other Study ID Numbers: 17-013839
R01HD087406-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Philadelphia:
youth
parents
posttraumatic stress
violence
violent injuries
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders