Posttraumatic Stress Disorder Clinical Trial
Official title:
Addressing Community Violence-related Traumatic Stress Symptoms in Children
Verified date | July 2023 |
Source | Children's Hospital of Philadelphia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
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 |
United States,
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 |
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 |
NCT02720497 -
The Efficacy of 90-Minute Versus 60-Minute Sessions of Prolonged Exposure for PTSD
|
N/A | |
Completed |
NCT01911585 -
Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure
|
N/A | |
Terminated |
NCT01408641 -
Topiramate for Alcohol Use in Posttraumatic Stress Disorder
|
N/A | |
Completed |
NCT01693978 -
Contingency Outcomes in Prolonged Exposure
|
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 |