Teenagers are invited to take part voluntarily in a research study of a study drug known as guanfacine extended release (Intuniv™) and a type of psychotherapy called Mindfulness Skills Training which teaches people how to focus on the present moment in a nonjudgmental manner to help them cope with their stresses and worries. Teenagers are being asked to take part in this study if they have had traumatic stress related over arousal symptoms. He/she may also have difficulties with worries, anxiety, temper, aggression, quick mood changes, behavior problems, and/or difficulties with symptoms of Attention Deficit Hyperactivity Disorder (ADHD) including inattention, hyperactivity, and impulsivity with or without Posttraumatic Stress Disorder (PTSD); and is not responding adequately to his/her current treatment. The primary purpose of the teenager's participation in this study is to help answer the following research question(s), and not to provide treatment for his or her condition: * To investigate if Intuniv™ helps for the symptoms of traumatic stress and emotional and behavioral overarousal in children with a history of traumatic developmental stress with and without PTSD. * To investigate if Intuniv™ helps your teenager engage with and benefit from Mindfulness Skills Training therapy * To better understand how Intuniv™ works in the brain. * To investigate how well your child tolerates Intuniv™ during the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Intuniv (guanfacine) is a prescription medicine used to treat attention deficit hyperactivity disorder (ADHD) in children who are at least 6 years old. An open-label trail of guanfacine extended release (GXR 1-4 mg/daily; Intuniv™) suggested benefits in improving behavioral and emotional regulation in children and adolescents with symptoms of traumatic stress. However, to date no controlled clinical trial has been completed assessing the effects of GXR on traumatic stress symptoms in youths
Mindfulness is a therapy for anxiety and stress. Mindfulness forms of therapy involve regulation of attention, maintaining it in immediate experience, regardless of the valence and desirability of the experience. To reduce anxiety, Mindfulness encourages observing and accepting anxiety-related thoughts
Placebo oral capsule
UConn Health
Farmington, Connecticut, United States
Changes in the Structured Trauma-Related Experiences and Symptoms Screener (STRESS)
a self-report and observer-report instrument for youths 7-18 years that inventories 25 adverse childhood experiences and potentially traumatic events and assesses symptoms of post-traumatic stress disorder using the revised criteria published in DSM 5. Total score and DSM 5 domains B-E are included (intrusive symptoms, avoidance, cognitive-mood symptoms, arousal-reactivity symptoms and symptoms of dissociation).
Time frame: Completed as part of the initial evaluation (T0), after drug dose has been determined to be stable and fixed (T1), and after completing the Mindfulness Therapy. (T2) (approximately 20 weeks in total)
Changes in theRetrospective-Modified Overt Aggression Scale (R-MOAS)
(R-MOAS) assesses the frequency and severity of 16 aggressive behaviors over the past week in four areas: verbal aggression, physical aggression towards others, aggression toward oneself, and destruction or hostile misuse of property. Numeric weighting amplifies the seriousness of more harmful behaviors in the total score. Reliability and validity data on the instrument are published. A total score ≥ 24 is required to identify clinically significant aggression.
Time frame: Completed as part of the initial evaluation (T0), after drug dose has been determined to be stable and fixed (T1), and after completing the Mindfulness Therapy. (T2)(approximately 20 weeks in total)
Changes in ADHD RS-IV
An 18-item caregiver-completed rating scale developed to measure the behaviors of youths with ADHD
Time frame: Completed as part of the initial evaluation (T0), after drug dose has been determined to be stable and fixed (T1), and after completing the Mindfulness Therapy. (T2)(approximately 20 weeks in total)
Changes in the Emotion Reactivity Scale (ERS)
A 21-item self-report measure of emotion sensitivity, intensity, and persistence. The scale assesses emotional reactivity.
Time frame: Completed as part of the initial evaluation (T0), after drug dose has been determined to be stable and fixed (T1), and after completing the Mindfulness Therapy. (T2). Also at each medication management appointment(approximately 20 weeks in total)
Youth Self Report (CBCL)
Assesses self-report functioning and internalizing and externalizing symptoms. The YSR contains social competence items and 112 items assessing self-reported symptoms.
Time frame: Completed at initial visit only (week 1)
Kaufman Brief Intelligence Test-2
The KBIT is normed for ages 4-90 years and yields a verbal IQ, non-verbal IQ, and full-scale IQ.
Time frame: Completed by the adolescent at the initial visit only (week 1)
Guanfacine Extended Release and Mindfulness Skills Therapy reducing traumatic stress
1\. To measure whether Guanfacine Extended Release (GXR) 1-7 mg/daily compared to placebo will help diminish traumatic stress-related symptoms of concentration difficulties, aggression and anger, irritability, anxiety, fear, and depression in 12-17 year old youths who have experienced lifetime traumatic stress as assessed by clinician-reports, and observer- and self-reports on psychometrically validated rating scales.
Time frame: 20 weeks
Tolerance of Guanfacine Extended Release in subjects between the ages of 12-17 years old.
2\. To measure how well 12-17 year-old children tolerate Guanfacine Extended Release (GXR) 1-7 mg/daily compared to placebo. Tolerance assessed by review of adverse events.
Time frame: 20 weeks
Clinical Global Impressions Improvement Scale
The CGI-Improvement scale assesses patient overall improvement of symptoms compared with symptoms at study baseline. It is rated on a 7-point scale with scores ranging between 1 ("very much improved), 2 ("improved"), 3 ("minimally improved"), 4 ("no change from baseline") to 7 ("very much worse").
Time frame: Completed ater drug dose has been determined to be stable and fixed (T1) and after completing the Mindfulness Therapy (T2) and each medication management visit.(approximately 20 weeks in total)
Clinical Global Impressions Severity Scale
The CGI-Severity scale assesses the overall severity of a patient's psychiatric condition on a 7-point scale with scores ranging from 1 ("not ill") to 7 ("extremely severe").
Time frame: Completed as part of the initial evaluation (T0), after drug dose has been determined to be stable and fixed (T1), and after completing the Mindfulness Therapy. (T2). Also at each medication management appointment(approximately 20 weeks in total)
Client Credibility Questionnaire (CCQ)
measures youth and parent expectancies of treatment
Time frame: the CCQ will be administered to all youth and parents at the end of session one following presentation of the treatment rationale(approximately 20 weeks in total)
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Group Engagement Scale (GES)
20-item scale, that assesses youth attitude/satisfaction toward their specific group. Each item is rated on a 9-point scale. Groups can prompt different attitudes among group members which can affect the effectiveness of the intervention. The GES yields high alphas (\>0.9). (Those receiving individual Mindfulness will not receive this scale)
Time frame: At each of the Mindfulness Skills Therapy sessions if the subject is in group therapy.(approximately 10 weeks)
The Screen for Child Anxiety Related Emotional Disorders (SCARED)
a 41-item self or observer-completed screen for child and adolescent anxiety disorders. Sub-scores assess for the presence of panic disorder, generalized anxiety disorder, separation anxiety disorder, social anxiety disorder, and significant school avoidance. Total scores ≥ 25 may indicate the presence of an anxiety disorder.
Time frame: Completed as part of the initial evaluation (T0), after drug dose has been determined to be stable and fixed (T1), and after completing the Mindfulness Therapy. (T2). Also at each medication management visit(approximately 20 weeks in total)
Patient Health Questionnaire (PHQ-9)
a 9-item self-report instrument assessing symptoms of depression. In clinically referred populations a total score ≥ 10 may identify clinically significant depression given the higher base-rate of depression in clinical populations than in epidemiological samples.
Time frame: Completed as part of the initial evaluation (T0), after drug dose has been determined to be stable and fixed (T1), and after completing the Mindfulness Therapy. (T2) Also at each medication management visit(approximately 20 weeks in total)