Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change in Child PTSD Symptom Scale (CPSS-5) |
The Child Post-Traumatic Stress Disorder (PTSD) Symptom Scale (CPSS-5) is a self-report scale designed to assess PTSD symptoms in children and adolescents ages 8-18. The measure screens for stressful life events and asks about the emotional impact of these events in the 4 weeks prior to the assessment. Items are rated on a 5-point scale from 0 (not at all) to 4 (almost always) for how often the problem bothers the youth in the prior 4 weeks. A total symptom severity rating is calculated by summing the ratings of all 20 items and ranges from 0-80, with a higher score indicating greater symptom severity. The CPSS-5 will be used to assess change in PTSD symptoms through study completion at the 3-month follow-up assessment. The scale will be completed at baseline about the prior 4 weeks, at week 7 about the prior 4 weeks, between weeks 14-16 (post-intervention) about the prior 4 weeks, and at the 3-month follow-up assessment about the prior 4 weeks. |
baseline, week 7, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the 4 weeks prior to the assessment date. |
|
| Primary |
Change in Clinician-Administered PTSD Scale for DSM-5, Child/Adolescent Version (CAPS-CA-5) |
The Clinician-Administered Post-Traumatic Stress Disorder (PTSD) Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DMS-5) - Child/Adolescent Version (CAPS-CA-5) is a 30-item scale that assesses PTSD in children and adolescents ages 7 and older based on the 20 DSM-5 PTSD symptoms. Each item is given a severity rating based on symptom frequency and intensity. Ratings are given for the 4 weeks prior to each assessment timepoint. A total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms and ranges from 0-80, with a higher score indicating greater symptom severity. The CAPS-CA-5 will be used to assess change in symptoms through study completion at the 3-month follow-up assessment. The measure will be administered at baseline rating the prior 4 weeks, between weeks 14-16 (post-intervention) rating the prior 4 weeks, and at the 3-month follow-up assessment rating the prior 4 weeks. |
baseline, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the 4 weeks prior to the assessment date. |
|
| Primary |
Change in Clinical Global Scale of Illness - Improvement/Severity (CGI-I/S) |
The Clinical Global Scale of Illness - Improvement/Severity (CGI-I/S) is a 2-item clinician-rated instrument that assesses change in global illness severity and global improvement from baseline prior to treatment to study completion at the 3-month follow-up assessment. The improvement item is scored on a 7-point scale and ranges from 1 (very much improved since the initiation of treatment) to 7 (very much worse since the initiation of treatment). The severity item is scored on a 7-point scale and ranges from 1 (normal) to 7 (among the most extremely ill patients). It will be administered at baseline rating the prior 2 weeks, at week 7 rating the prior 2 weeks, between weeks 14-16 (post-intervention) rating the prior 2 weeks, and at the 3-month follow-up assessment rating the prior 2 weeks. |
baseline, week 7, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the 2 weeks prior to the assessment date |
|
| Secondary |
Change in Mood and Feelings Questionnaire (MFQ) |
The Mood and Feelings Questionnaire (MFQ) is a 33-item self-report measure completed by the parent and adolescent to identify symptoms of depression in children and adolescents ages 6-17. Items are scored from 0 (not true) to 2 (true). A total score is calculated by summing the point values of all items and ranges from 0 to 66, with higher scores indicating more severe depressive symptoms. The measure will be completed at baseline about the prior 2 weeks, at week 7 about the prior 2 weeks, between weeks 14-16 (post-intervention) about the prior 2 weeks, and at the 3-month follow-up assessment about the prior 2 weeks. Scores at these timepoints will enable assessment of change in symptoms through completion of the study at the 3-month follow-up assessment. |
baseline, week 7, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the 2 weeks prior to the assessment date |
|
| Secondary |
Change in Social Adjustment Scale-Self Report (SAS-SR) |
The Social Adjustment Scale-Self Report (SAS-SR) is a 23-item scale that assesses social adjustment/functioning for the past 2 weeks in 5 areas: overall adjustment, school behavior, relationships with friends, relationships with family, and dating. Items are scored on a Likert scale from 1 to 5. A total score is calculated by averaging all items. Subscale scores are calculated by averaging all items within each subscale. The total and subscale scores range from 1-5, with higher scores indicating more impaired social adjustment. The SAS-SR will be completed at baseline about the prior 2 weeks, at week 7 about the prior 2 weeks, between weeks 14-16 (post-intervention) about the prior 2 weeks, and at the 3-month follow-up assessment about the prior 2 weeks. Ratings will provide information regarding change in social adjustment through study completion at the 3-month follow-up assessment. |
baseline, week 7, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the 2 weeks prior to the assessment date |
|
| Secondary |
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) |
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician-administered measure that collects information on suicidal behavior, suicide attempts, and presence and intensity of suicidal ideation. The majority of the items are scored as yes or no for being present, severity items for suicidal ideation are scored regarding frequency and intensity. A numerical Suicidal Ideation Score is equivalent to the maximum category of items 1-5 that is present at the assessment, where 0 is no suicidal ideation and 5 is active suicidal ideation with specific plan or intent. The baseline version will assess lifetime of the adolescent and past 4 weeks of suicidal ideation and behavior. At week 7, between 14-16 weeks (post-intervention), and at the 3-month follow-up timepoint, it will be administered and assess suicidal ideation and behavior for the past 7 weeks at weeks 7 and 14-16 (post-intervention), and the past 36 weeks at the 3-month follow-up assessment. |
lifetime from birth to baseline time period, the month (4 weeks) prior to the initial baseline assessement prior to treatment, and at weeks 7, 14-16 (post intervention) and 3 month follow-up ratings on behavior since prior assessment up to 36 weeks. |
|
| Secondary |
Change in Children's Global Assessment Scale (CGAS) |
The Children's Global Assessment Scale (CGAS) is a clinician-rated scale that assesses overall/global impairment across aspects of the child's life for the 4 weeks prior to the assessment. It has been found to be a reliable instrument for assessing impairment in children with psychiatric disorders. Based on clinical interview, the evaluator assigns a single score for the person's level of impairment in various domains of his/her life including relationships, school, work, and symptomatology in the 4 weeks prior to the assessment. A single global rating is provided on a scale of 1-100, with 100 being no impairment. It will be completed at baseline, week 7, between weeks 14-16 (post-intervention), and at the 3-month follow-up assessment, rating the 4 weeks prior to each of these timepoints. The repeated timepoints will allow assessment of change from baseline through the study completion at the 3-month follow-up assessment. |
baseline, week 7, between weeks 14-16 (post-intervention), and at the 3 month follow-up, each time rating the past 4 weeks prior to the assessment date |
|
| Secondary |
Change in Conflict Behavior Questionnaire (CBQ) |
The Conflict Behavior Questionnaire is a self-report that assesses the parent-child relationship for the 2 weeks prior to the assessment. It has been found to be a reliable measure of the quality of the relationship between mother and adolescent and father and adolescent. It is completed both by the adolescent about the parents and the parent about the adolescent. It is a 20-item scale scored on a true/false scale. The total score is calculated by summing the point values of all of the items and ranges from 0-20. Higher scores indicate greater conflict in the relationship. The CBQ will be completed at baseline, week 7, between weeks 14-16 (post-intervention), and at the 3-month follow-up assessment, rating the 2 weeks prior to each of these timepoints. The repeated timepoints will allow assessment of the change from baseline through the study completion at 3-month follow-up assessment. |
baseline, week 7, between weeks 14-16(post-intervention), and at the 3 month follow-up, each time rating the past 2 weeks prior to the assessment date. |
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