Attention Deficit Hyperactivity Disorder Clinical Trial
Official title:
Trial of Reminder Focused Positive Psychiatry in Comorbid Attention Deficit Hyperactive Disorder With Posttraumatic Stress Disorder
Verified date | April 2020 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 11 |
Est. completion date | June 29, 2019 |
Est. primary completion date | June 29, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 9 Years to 18 Years |
Eligibility |
Inclusion Criteria: - English speaking Boy/Girl Age 9 - 18 years old - Able to read/write in English - Documented ADHD and PTSD, and parents provided informed consent Exclusion Criteria: - Psychotic or Mood Disorders or Self-injurious behavior - Cognitive disorder or other neurodevelopmental disorders - Diagnosis of substance use disorder |
Country | Name | City | State |
---|---|---|---|
United States | UCLA Kern | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles | American Academy of Child Adolescent Psychiatry., Kern Medical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acceptability of RFPP to treat adolescents with PTSD and ADHD | Measure the acceptability after 6-week intervention where both adolescents and parents will be asked about overall satisfaction with treatment using the validated and reliable Client Satisfaction Questionnaire (CSQ-8). The aim is a mean above 20.00 (Good-Excellent) on the 8 to 32 scale of CSQ-8, and sessions' mean of 4.00 (very valuable session) on the 0 to 5 Session Feedback Questionnaire scale (SFQ). |
12 month | |
Primary | Feasibility of RFPP to treat adolescents with PTSD and ADHD | Measure the feasibility of RFPP intervention measured by retention rate of participants in RFPP group post-intervention. The goal is a =50% referred-to-enrolled rate, =70% intervention completion rate and 70% 12-month follow up. |
12 month | |
Primary | Fidelity of RFPP to treat adolescents with PTSD and ADHD | Measure the adherence and competence of therapists to the model will be assessed by live observation, role play and provider self-report and checklist. Session will observed or listened to as they are happening. Therapists demonstrate specific skills which might use with a client generically and as applied to specific clinical cases required by the model. Therapists describe in detail exactly what they do in the session and how the client respond, also complete checklists following sessions. Interrater reliability will be assessed using the chance-corrected weighted kappa statistic from 0-1, with aim of 0.8+ (almost perfect agreement). |
12 month | |
Secondary | Change in PTSD symptoms in response of RFPP at 6-week intervention and 12-month follow up. | Measure the change in reactivity of trauma reminder and core PTSD symptoms in response to RFPP at 6-week intervention and 12-month follow up, compared to changes in such measures in response to TFCBT. The change in reactivity to trauma reminder - assessed with UCLA Trauma Reminder Inventory questionnaire with range of 0 to 88- , PTSD core symptoms - assessed by Clinician Administered PTSD Scale children version (CAPS-CA) questionnaire with range of 0 to 160. All measures demonstrated acceptable internal consistency. |
12 month | |
Secondary | Change in ADHD symptoms in response of RFPP at 6-week intervention and 12-month follow up. | Measure the change in core ADHD symptoms in response to RFPP at 6-week intervention and 12-month follow up, compared to changes in such measures in response to TFCBT. | 12 month | |
Secondary | Change in mental wellbeing in response of RFPP at 6-week intervention and 12-month follow up. | Measure the change in positive biopsychosocial trait, mental wellbeing and parent-child interactions in response to RFPP at 6-week intervention and 12-month follow up, compared to changes in such measures in response to TFCBT. The percent of change in questionnaires of PERMA (Positive emotion, engagement, relationships, meaning, and accomplishment), gratitude, posttraumatic growth inventory, Connor-Davidson resilience scale, and PACHIQ (Parent-Child Interaction Questionnaire) with range of 0- 100%, where 60%+ represent optimal biopsychosocial trait and wellbeing. All measures demonstrated acceptable internal consistency. |
12 month | |
Secondary | Change in physiologic biomarkers in response of RFPP at 6-week intervention and 12-month follow up. | Measure the change in fingertip vascular function, C reactive protein (CRP) and homocysteine in response to RFPP at 6-week intervention and 12-month follow up, compared to changes in such measures in response to TFCBT. The change in digital thermal monitoring (DTM) of fingertip vascular function - through reactive hyperemia procedure, range ratio of -1 to 2.5 - CRP with range of 0-50 mg/L, and homocysteine with range of 0-100 mcmol/L. All measures are standardized and demonstrated acceptable internal consistency. |
12 month | |
Secondary | Change in the rate of psychiatric hospitalization and suicidality in response of RFPP at 6-week intervention and 12-month follow up. | Measure the change in rate of psychiatry hospitalization and suicidality in response to RFPP at 6-week intervention and 12-month follow up, compared to changes in such measures in response to TFCBT. The percent change in the rate of psychiatry hospitalization and suicidality, number and frequency of such events. All verified by clinicians blinded to the study. |
12 month |
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