Assault, Parent-Child Relations, Posttraumatic Stress Disorder, Violence, Non-accidental, Youth
Conditions
Keywords
youth, parents, posttraumatic stress, violence, violent injuries
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.
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 110 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.
Interventions
BEHAVIORALChild 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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Drexel University
University of Colorado, Denver
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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.
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.
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Child PTSD Symptom Scale (CPSS-5) score from baseline to 4 months post-ED visit. | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Revised Children's Anxiety and Depression Scale (RCADS) short form score from baseline to 10 months post-ED visit | 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. |
| Change in self-reported substance use as assessed by Behavioral Health Screen (BHS) items from baseline to 4 months post-ED visit | 4 months | Assesses use of alcohol and illicit drugs in participants 12 years of age and older. |
| Change in self-reported substance use as assessed by Behavioral Health Screen (BHS) items from baseline to 10 months post-ED visit | 10 months | Assesses use of alcohol and illicit drugs in participants 12 years of age and older. |
| Change in Revised Children's Anxiety and Depression Scale (RCADS) short form score from baseline to 4 months post-ED visit | 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. |
| Change in Strengths and Difficulties Questionnaire-Child and Parent Report (SDQ & SDQ-P) from baseline to 10 months post-ED visit | 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. |
| Change in Child PTSD Symptom Scale (CPSS-5) score from baseline to 10 months post-ED visit. | 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. |
| Change in Strengths and Difficulties Questionnaire-Child and Parent Report (SDQ & SDQ-P) from baseline to 4 months post-ED visit | 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. |
Countries
United States
Outcome results
None listed