Ignite Creation Date:
2024-05-06 @ 2:30 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04336072
Status:
COMPLETED
Last Update Posted:
2020-04-08
First Post:
2020-03-31
Brief Title:
Reminder Focused Positive Psychiatry in Adolescents With ADHD and PTSD
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Trial of Reminder Focused Positive Psychiatry in Comorbid Attention Deficit Hyperactive Disorder With Posttraumatic Stress Disorder
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This feasibility study investigates the impact of reminder-focused-positive-psychiatry RFPP on attention-deficit-hyperactive-disorder ADHD and posttraumatic-stress-disorder PTSD symptoms vascular-function inflammation and well-being of adolescents with comorbid ADHD PTSD
In this randomized clinical trial 24 subjects with comorbid ADHD and PTSD aged 12-18 years old free of known medical and other major psychiatric disorders will be recruited from the pool of eligible subjects at Los Angeles and Kern County Children Mental Health Centers 1500 subjects after obtaining informed consent from parents as well as subjects assentment Commonwealth and Oswell Kern County Mental Health Clinic will be used for subjects enrollment randomization as well as study implementation from trauma disorder clinic Kern Medical will be used for manuscript write up and analyses
Adolescents will be randomized to group-RFPP or trauma-focused group-cognitive-behavioral-therapy TF-CBT Participants will complete twice-weekly-intervention for 6-weeks-trial The group-RFPP-intervention will be inclusive of RFPP interventions on a traumatic-reminders and b Avoidance negative-cognition Vascular-function-measured as temperature-rebound TR C-reactive-protein CRP homocysteine SNAP-questionnaire Clinician-Administered PTSD-Scale-children-version CAPS-CA and neuropsychiatric-measures will be measured at baseline and 6th week Subjects will be followed for 12 months
Parents and subjects will be informed of the risks associated with use of venipuncture and loss of confidentiality of collected information
In this randomized clinical trial 24 subjects with comorbid ADHD and PTSD aged 12-18 years old free of known medical and other major psychiatric disorders will be recruited from the pool of eligible subjects at Los Angeles and Kern County Children Mental Health Centers 1500 subjects after obtaining informed consent from parents as well as subjects assentment Commonwealth and Oswell Kern County Mental Health Clinic will be used for subjects enrollment randomization as well as study implementation from trauma disorder clinic Kern Medical will be used for manuscript write up and analyses
Adolescents will be randomized to group-RFPP or trauma-focused group-cognitive-behavioral-therapy TF-CBT Participants will complete twice-weekly-intervention for 6-weeks-trial The group-RFPP-intervention will be inclusive of RFPP interventions on a traumatic-reminders and b Avoidance negative-cognition Vascular-function-measured as temperature-rebound TR C-reactive-protein CRP homocysteine SNAP-questionnaire Clinician-Administered PTSD-Scale-children-version CAPS-CA and neuropsychiatric-measures will be measured at baseline and 6th week Subjects will be followed for 12 months
Parents and subjects will be informed of the risks associated with use of venipuncture and loss of confidentiality of collected information
Detailed Description:
PTSD and ADHD are major public health problems Many individuals with comorbid ADHD and PTSD continue to suffer despite treatment with FDA approved medications including antidepressants sertraline and paroxetine prazosin andor the Institute of Medicine approved psychotherapy Long-term outcomes with even the most intensive treatments although significant were modest and reveal persistent morbidity and disability for many individuals with PTSD especially in those with comorbid ADHD19 While current treatments focused on treatment to reduce the associated suffering and disability of morbid ADHD and PTSD These interventions are however not sufficient to promote human welfare improve levels of positive psychosocial characteristics PPCs and resilience Positive psychiatry PP focuses on promoting well-being enhancing behavioral and mental wellness in both youth and adults20 however its impact on youth with comorbid PTSD and ADHD has not been studied We hypothesize that PP intervention would significantly enhance vascular function resilience wellbeing increase posttraumatic growth and reduce inflammation in morbid ADHD and PTSD This randomized trial will the first to investigate the impact of psychiatric positive interventions as opposed to intervention on ameliorating vulnerability on adolescents with morbid ADHD and PTSD Findings of this study can provide a better understanding of impact of PP on psychiatric and biomolecular characteristics of adolescent with PTSD and ADHD If successful this proposal will be available for large scale studies following which it could potentially be deployed in daily clinical practice
RESEARCH METHOD
In this randomized clinical trial the three related and overlapping specific aims are directed to examine the feasibility of PP intervention as well as its impact on positive psychological wellbeing and neurovascular inflammation in adolescent subjects with comorbid ADHD and PTSD
Synopsis In this randomized clinical trial 24 subjects with comorbid ADHD and PTSD aged 12-18 years old free of known medical and other major psychiatric disorders will be recruited from the pool of eligible subjects at Los Angeles and Kern County Children Mental Health Centers 1500 subjects after obtaining informed consent from parents as well as subjects assentment Commonwealth and Oswell Kern County Mental Health Clinic will be used for subjects enrollment randomization as well as study implementation from trauma disorder clinic Kern Medical will be used for manuscript write up and analyses
Parents and subjects will be informed of the risks associated with use of venipuncture and loss of confidentiality of collected information Eligible subjects will be randomized to 1 PP group intervention or 2 control condition group 12 in each group for 6 week intervention and 6 week of follow up
Recruited subject will be followed before during and after interventions Both groups will be on adequate stimulant therapy for ADHD Group PP intervention consists of 12 sessions of group PP in 6 week that will be completed by the participant with the guidance of a trainer Sham control condition consists of 12 sessions in 6 week of group exercises that will be completed by the participant with the guidance of a trainer
All subjects will undergo radial artery flow mediated dilatation a measure of vascular function venipuncture for measuring of CRP homocysteine and IL-6 as well as completion of positive psychiatry and wellbeing batteries at baseline 3rd and 6th of intervention and 12th week follow up
A- Measurements A1History and Physical Exam HP All consented patients will undergo a baseline HP intervention and post-trial observation periods by a physician
A2 Medications All medications during pre-trial intervention and post-trial will be charted A3 Psychiatry Batteries SNAP teacher and parent questionnaire Positive Psychotherapy Inventory VIA Survey of Character Strengths PERMA PANAS optimism posttraumatic growth inventory Connor Davidson resilience scale Clinician Administered PTSD Scale CAPS children version will be measured at baseline 3rd 6th and 12th week
A4 Vascular Function Assessment via FMD After resting in a supine position in a room with temperature 23 to 25 C for 30 minutes brachial artery endothelial function will be assessed noninvasively by ultrasound using reactive hyperemia procedure Brachial artery diameter above antecubital crease will be measured at least 60 cycles from baseline to 5 min cuff inflation and 5 min post cuff deflation
A5Venipuncture and laboratory measurements Venous blood samples of all subjects after 8 hours of fasting will be drawn at baseline 3rd 6th and 12th week The assessment of C-reactive protein CRP and homocysteine will be performed using the standard techniques The concentrations of IL-6 will be determined using commercially available solid-phase sandwich enzyme-linked immunosorbent assay kits The range of detection is 15-1540 pgml for IL-621
B- Interventions
B1Reminder Focused Positive Psychiatry RFPP group will receive 6 week 12 sessions and 12 exercises of positive psychiatry to improve wellbeing The group PP exercises are inclusive of Posttraumatic Growth Resilience Gratitude and Optimism Self-regulation and Personal Strength Enjoyable and meaningful activities Personal mastery and self-efficiency Groups last approximately 60 minutes and positive responding responding to others in an active and constructive way personal strengths gratitude forgiveness and identifying positives from negative situations will be included Nondirective prompts will be used to stimulate in-depth discussion Feedback from subjects will be captured All facilitators have experience of facilitating therapeutic groups and of working with individuals with a diagnosis of ADHD and PTSD Facilitators participate in all exercises themselves they share personal examples from their own lives with the group and are encouraged to do the ongoing exercise in their own time Participants are not prohibited from sharing distressing unpleasant or negative states and experiences in the group Negative contributions are validated but not focused on Instead facilitators establish a link between the negative experience and one or more of the interventions target areas
C Statistical Analysis
All statistical analyses will be performed during the last 4 months of the study T test and Chi Square test will be used to assess differences between groups The association between PP and control condition will be analyzed by linear and mixed regression analyses In addition the change in overall symptoms ADHD and PTSD specific symptoms and neurovascular inflammation in response to PP will be evaluated These analyses will be adjusted for demographics mental and medical covariates
D Sample Size for Specific Aim 1-3
A measurable change in vascular function and increase in PERMA are outcomes of interest The sample size of 12 per group that has been chosen based on priori study will detect a 20 difference in vascular function and PERMA score amongst groups with a study power of 08 and significance level of 005
RESEARCH METHOD
In this randomized clinical trial the three related and overlapping specific aims are directed to examine the feasibility of PP intervention as well as its impact on positive psychological wellbeing and neurovascular inflammation in adolescent subjects with comorbid ADHD and PTSD
Synopsis In this randomized clinical trial 24 subjects with comorbid ADHD and PTSD aged 12-18 years old free of known medical and other major psychiatric disorders will be recruited from the pool of eligible subjects at Los Angeles and Kern County Children Mental Health Centers 1500 subjects after obtaining informed consent from parents as well as subjects assentment Commonwealth and Oswell Kern County Mental Health Clinic will be used for subjects enrollment randomization as well as study implementation from trauma disorder clinic Kern Medical will be used for manuscript write up and analyses
Parents and subjects will be informed of the risks associated with use of venipuncture and loss of confidentiality of collected information Eligible subjects will be randomized to 1 PP group intervention or 2 control condition group 12 in each group for 6 week intervention and 6 week of follow up
Recruited subject will be followed before during and after interventions Both groups will be on adequate stimulant therapy for ADHD Group PP intervention consists of 12 sessions of group PP in 6 week that will be completed by the participant with the guidance of a trainer Sham control condition consists of 12 sessions in 6 week of group exercises that will be completed by the participant with the guidance of a trainer
All subjects will undergo radial artery flow mediated dilatation a measure of vascular function venipuncture for measuring of CRP homocysteine and IL-6 as well as completion of positive psychiatry and wellbeing batteries at baseline 3rd and 6th of intervention and 12th week follow up
A- Measurements A1History and Physical Exam HP All consented patients will undergo a baseline HP intervention and post-trial observation periods by a physician
A2 Medications All medications during pre-trial intervention and post-trial will be charted A3 Psychiatry Batteries SNAP teacher and parent questionnaire Positive Psychotherapy Inventory VIA Survey of Character Strengths PERMA PANAS optimism posttraumatic growth inventory Connor Davidson resilience scale Clinician Administered PTSD Scale CAPS children version will be measured at baseline 3rd 6th and 12th week
A4 Vascular Function Assessment via FMD After resting in a supine position in a room with temperature 23 to 25 C for 30 minutes brachial artery endothelial function will be assessed noninvasively by ultrasound using reactive hyperemia procedure Brachial artery diameter above antecubital crease will be measured at least 60 cycles from baseline to 5 min cuff inflation and 5 min post cuff deflation
A5Venipuncture and laboratory measurements Venous blood samples of all subjects after 8 hours of fasting will be drawn at baseline 3rd 6th and 12th week The assessment of C-reactive protein CRP and homocysteine will be performed using the standard techniques The concentrations of IL-6 will be determined using commercially available solid-phase sandwich enzyme-linked immunosorbent assay kits The range of detection is 15-1540 pgml for IL-621
B- Interventions
B1Reminder Focused Positive Psychiatry RFPP group will receive 6 week 12 sessions and 12 exercises of positive psychiatry to improve wellbeing The group PP exercises are inclusive of Posttraumatic Growth Resilience Gratitude and Optimism Self-regulation and Personal Strength Enjoyable and meaningful activities Personal mastery and self-efficiency Groups last approximately 60 minutes and positive responding responding to others in an active and constructive way personal strengths gratitude forgiveness and identifying positives from negative situations will be included Nondirective prompts will be used to stimulate in-depth discussion Feedback from subjects will be captured All facilitators have experience of facilitating therapeutic groups and of working with individuals with a diagnosis of ADHD and PTSD Facilitators participate in all exercises themselves they share personal examples from their own lives with the group and are encouraged to do the ongoing exercise in their own time Participants are not prohibited from sharing distressing unpleasant or negative states and experiences in the group Negative contributions are validated but not focused on Instead facilitators establish a link between the negative experience and one or more of the interventions target areas
C Statistical Analysis
All statistical analyses will be performed during the last 4 months of the study T test and Chi Square test will be used to assess differences between groups The association between PP and control condition will be analyzed by linear and mixed regression analyses In addition the change in overall symptoms ADHD and PTSD specific symptoms and neurovascular inflammation in response to PP will be evaluated These analyses will be adjusted for demographics mental and medical covariates
D Sample Size for Specific Aim 1-3
A measurable change in vascular function and increase in PERMA are outcomes of interest The sample size of 12 per group that has been chosen based on priori study will detect a 20 difference in vascular function and PERMA score amongst groups with a study power of 08 and significance level of 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None