Reminder Focused Positive Psychiatry in Adolescents With ADHD and PTSD
Condition: Posttraumatic Stress Disorder; Attention Deficit Hyperactivity Disorder
MeSH terms: Stress Disorders, Traumatic; Attention Deficit Disorder with Hyperactivity; Stress Disorders, Post-Traumatic
Study type: Interventional

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.
    

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 and/or 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 ADHD.19 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 A1.History and Physical Exam (H&P): All consented patients will undergo a
      baseline H&P, 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.

      A5.Venipuncture 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 pg/ml for
      IL-6.21

      B- Interventions:

      B1.Reminder 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
      intervention's 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 0.8 and
      significance level of 0.05.
    

Intervention name(s): RFPP; TFCBT
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: After obtaining informed consent from parents and informed assent from eligible adolescents with comorbid ADHD and PTSD, participants will be randomized into: a) RFPP group therapy or trauma focused cognitive behavioral group therapy
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment