Sequencing Treatments for Mothers With ADHD and Their At - Risk Children

The overarching goal of this study is to construct and evaluate an adaptive intervention
(i.e., an individualized treatment protocol that is adjusted based on the child-mother dyad's
initial response to treatment) to improve the trajectory of ADHD outcomes in at-risk
children. Our primary outcome measure for the child will be whether child ADHD symptoms on
the Conners Parent and Teacher Rating Scales decreased at the completion of the study. Our
secondary outcome measure will be whether there was a need for medication for the child over
the course of the study. The primary outcome for the mother will be the Conners Adult ADHD
Rating Scale (CAARS) Attention Scale and the Clinical Global Impression-Severity scale
(CGI-S).

Mothers Inclusion Criteria:

- Sign informed consent

- Be between 21-50 years old (inclusive) at the screening visit and English-speaking

- At screening (after washout, if required) meet full Diagnostic and Statistical Manual
(DSM-IV) criteria for ADHD, any subtype

- Have current CGI-S-ADHD rating > 4 and < 8

- Have findings on physical exam (PE), laboratory studies, vital signs, and
electrocardiogram (ECG) judged to be normal for age with no contraindications for
methylphenidate (MPH) treatment

- Have pulse and blood pressure (BP) within 95% of age and gender mean

- Commit to the entire visit schedule for the study

- Be able to complete all study assessments

- Women of childbearing potential (not surgically sterile or post-menopausal) must agree
to use a medically-accepted contraception method consistently

- Mothers with comorbid mood/anxiety disorders which are effectively treated with
Selective Serotonin Reuptake Inhibitors (SSRIs) will be eligible for participation,
provided this medication has not changed within 30 days, is well tolerated, and that
current mood symptoms are not severe or associated with active suicidal ideation.
Also, the prescribing physician must approve of their participation in the study.

Mothers Exclusion Criteria:

- History of allergic reactions or severe negative response to study medications

- History of alcohol/substance abuse in the past 3 months or a positive urinary toxic
screen on initial evaluation that is not explained by a time-limited medical
circumstance

- History of or current bipolar illness, schizophrenia, psychoses, or significant
suicidal risk

- History of chronic or acute medical disorder for which stimulant therapy would be
contraindicated (e.g., glaucoma, hypertension)

Child Inclusion Criteria:

- Sign assent if older than 6

- Be between the ages of 4-8

- symptoms of ADHD (Conners Hyperactivity Index > 60), no prior treatment with effective
doses of stimulants, defined as one or more weeks of treatment with adequate doses.