Guanfacine Extended Release and Mindfulness Skills Therapy

Inclusion Criteria:

- A lifetime history of traumatic stress documented by self and/or caregiver response on
the youth self-report and or caregiver-report Structured Trauma-Related Experiences &
Symptoms Screener (STRESS) (i.e., at least one yes response on STRESS items 1-25). AND

- A baseline STRESS total score ≥ 21 for females or a baseline STRESS total score ≥ 17
for males (STRESS items # 26-48: range of total scores: 0-69) 68 as completed by
caregiver OR youth.

AND/OR

- A lifetime history of traumatic stress documented by self and/or caregiver response on
the youth self-report and or caregiver-report Structured Trauma-Related Experiences &
Symptoms Screener (STRESS) (i.e., at least one yes response on STRESS items 1-25). AND

- Clinically significant aggressive behavior during the preceding week assessed by a
caregiver-completed Retrospective Modified Overt Aggression (R-MOAS ≥ 24).73 AND

- A baseline Clinical Global Impressions-Severity Score ≥ 4.74

- Assent of child and consent of both parents/caregivers.

- Living with a caregiver legally empowered to permit study enrollment and able to
complete protocol assessments.

- English speaking

- The child is not responding to or is not tolerating well their current treatment as
reported by the parent or child.

- If female and reports that she is sexually active: Is willing to take a pregnancy test
before study participation AND is willing to take an additional pregnancy test during
the study as appropriate and necessary, and as determined by the Medical Director of
the study.

- Child and parent willing to give permission for the study team to contact the child's
primary care physician, mental health clinician and /or mental health prescriber to
communicate any changes in child's symptom status or medications as a result of
participation in this research.

Exclusion Criteria

:• A history of cardiovascular disease, previous history of ECG abnormalities, syncope,
exercise-induced cardiovascular symptoms, or any other unstable medical illness/allergy
(i.e., seizure disorder) that in the opinion of the site Medical Director precludes
enrollment in the study. A clinically significant history of Raynaud's disease is
exclusionary.

- Autistic disorder, persons with intellectual disability (IQ ≤ 70), clinically
significant (in the judgment of the site Medical Director) substance abuse disorder
(within the past 30 days), bipolar I disorder, schizophrenia or other psychotic
disorder, or major depressive disorder with symptoms that are severe enough (e.g.
suicidality) that in the opinion of the site Medical Director excludes study
participation.

- Concomitant Medications: Use of other psychiatric medications including extended
release guanfacine (study drug) besides a stable dose of stimulants or atomoxetine for
ADHD for the study duration is exclusionary for this protocol. All other medications
will undergo discontinuation.

- Patients who are unable to comply with the study protocol.

- Females of childbearing age that are sexually active and not receiving a medically
acceptable form of birth control and/or active pregnancy.

- Already taking Guanfacine Extended Release