Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03334942
Other study ID # 17-013839
Secondary ID R01HD087406-01A1
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 2, 2017
Est. completion date May 31, 2024

Study information

Verified date July 2023
Source Children's Hospital of Philadelphia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 132
Est. completion date May 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 8 Years to 18 Years
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (4)

Lead Sponsor Collaborator
Children's Hospital of Philadelphia Drexel University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Child PTSD Symptom Scale (CPSS-5) score from baseline to 4 months post-ED visit. 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. 4 months
Secondary Change in Revised Children's Anxiety and Depression Scale (RCADS) short form score from baseline to 4 months post-ED visit 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. 4 months
Secondary Change in Revised Children's Anxiety and Depression Scale (RCADS) short form score from baseline to 10 months post-ED visit 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. 10 months
Secondary Change in self-reported substance use as assessed by Behavioral Health Screen (BHS) items from baseline to 4 months post-ED visit Assesses use of alcohol and illicit drugs in participants 12 years of age and older. 4 months
Secondary Change in self-reported substance use as assessed by Behavioral Health Screen (BHS) items from baseline to 10 months post-ED visit Assesses use of alcohol and illicit drugs in participants 12 years of age and older. 10 months
Secondary Change in Strengths and Difficulties Questionnaire-Child and Parent Report (SDQ & SDQ-P) from baseline to 4 months post-ED visit 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. 4 months
Secondary Change in Strengths and Difficulties Questionnaire-Child and Parent Report (SDQ & SDQ-P) from baseline to 10 months post-ED visit 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. 10 months
Secondary Change in Child PTSD Symptom Scale (CPSS-5) score from baseline to 10 months post-ED visit. 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. 10 months
See also
  Status Clinical Trial Phase
Completed NCT03384706 - A Comparison of CPT Versus ART Versus WL N/A
Completed NCT03418129 - Neuromodulatory Treatments for Pain Management in TBI N/A
Completed NCT03129204 - Sensation Awareness Focused Training for Spouses N/A
Recruiting NCT05651295 - A Precision Medicine Approach to Target Engagement for Emotion Regulation N/A
Completed NCT05113277 - Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention N/A
Recruiting NCT05327504 - Written Exposure Therapy for Veterans With SUD and PTSD N/A
Recruiting NCT05843695 - Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety N/A
Active, not recruiting NCT05530642 - An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel N/A
Completed NCT00644423 - Omega-3 Fatty Acids and Post Traumatic Stress Disorder (PTSD) N/A
Completed NCT02989987 - NET for SGBV Survivors in Eastern DR Congo N/A
Completed NCT02320799 - Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV+ Women in Kenya N/A
Recruiting NCT02293291 - Thermal Clinic Treatment in Gulf War Illness Phase 1/Phase 2
Completed NCT02242136 - Treatment of Posttraumatic Stress Disorder and Aggressive Behavior in Soldiers and Ex-combatants N/A
Completed NCT01911585 - Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure N/A
Completed NCT02720497 - The Efficacy of 90-Minute Versus 60-Minute Sessions of Prolonged Exposure for PTSD N/A
Completed NCT01693978 - Contingency Outcomes in Prolonged Exposure N/A
Terminated NCT01408641 - Topiramate for Alcohol Use in Posttraumatic Stress Disorder N/A
Completed NCT01469754 - Longitudinal Survey Analysis in Lymphoma Survivors N/A
Completed NCT02362477 - Telemental Health and Cognitive Processing Therapy for Female Veterans With Military-related PTSD Phase 3
Terminated NCT01239173 - Emotional Memory Reactivation in Posttraumatic Stress Disorder Phase 3