Reminder Focused Positive Psychiatry in Adolescents With ADHD and PTSD

NCT04336072 | Completed DMC

• 1 other identifier: IRB # 16030
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder; Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Change in PTSD symptoms in response of RFPP at 6-week intervention and 12-month follow up.

  12 month

• Change in ADHD symptoms in response of RFPP at 6-week intervention and 12-month follow up.

  12 month

• Change in mental wellbeing in response of RFPP at 6-week intervention and 12-month follow up.

  12 month

• Change in physiologic biomarkers in response of RFPP at 6-week intervention and 12-month follow up.

  12 month

• Change in the rate of psychiatric hospitalization and suicidality in response of RFPP at 6-week intervention and 12-month follow up.

  12 month

Study Arms (2)

Reminder Focused Positive Psychiatry (RFPP)

EXPERIMENTAL

RFPP aims to enhance contextual discrimination and emotional regulation, and promote the use of adaptive coping strategies in response to trauma reminders, including recognizing reminders, shifting attention from intrusive memories during exposure to reminders to a focus on positive feelings, thoughts, goals, and choices

Behavioral: RFPP

Trauma Focused Cognitive Behavioral Therapy (TFCBT)

ACTIVE COMPARATOR

TFCBT is inclusive of the trauma narrative (TN) \& processing components facilitated the child talking about memories individually and in groups, the last sessions focused on grief-specific elements.

Behavioral: TFCBT

Interventions

RFPP BEHAVIORAL

Reminder Focused Positive Psychiatry (RFPP)

TFCBT BEHAVIORAL

Trauma Focused Cognitive Behavioral Therapy (TFCBT)

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• English speaking Boy/Girl Age 9 - 18 years old
• Able to read/write in English
• Documented ADHD and PTSD, and parents provided informed consent

You may not qualify if:

• Psychotic or Mood Disorders or Self-injurious behavior
• Cognitive disorder or other neurodevelopmental disorders
• Diagnosis of substance use disorder

Sponsors & Collaborators

• University of California, Los Angeles: lead
• American Academy of Child Adolescent Psychiatry.: collaborator
• Kern Medical Center: collaborator

Study Sites (1)

UCLA Kern

Los Angeles, California, 93306, United States

Location

Related Publications (1)

• Ahmadi N, Chaudhry S, Salam T, Rodriguez J, Kase M, Olango G, Molla M, McCracken J, Pynoos R. A Randomized Controlled Feasibility Trial of Reminder-Focused Positive Psychiatry in Adolescents With Comorbid Attention-Deficit/Hyperactivity Disorder and Posttraumatic Stress Disorder. Prim Care Companion CNS Disord. 2020 Sep 3;22(5):19m02579. doi: 10.4088/PCC.19m02579.

  PMID: 32898346 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Study Officials

• Naser Ahmadi, MD PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomly assigned to groups. Outcome assessors will be blinded to participants and interventions
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Model Details: 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

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 7, 2020
• Study Start: January 10, 2017
• Primary Completion: June 29, 2019
• Study Completion: June 29, 2019
• Last Updated: March 30, 2026

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)