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

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

We hypothesize that successfully treating maternal Attention Deficit Hyperactivity Disorder (ADHD) will have a beneficial effect that extends to the child. We believe that multi-component interventions combining maternal stimulant medication, Lisdexamfetamine (LDX), and Behavioral Parent Training (BPT) will improve parenting, maternal, and child outcomes. In terms of improved parenting, we hypothesize that some mothers may respond well to LDX or BPT alone and therefore may not require multi-modal treatment, whereas others may benefit most from multi-modal treatment

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seattle Children's Hospital
• Collaborator: Shire
• Treatments: Lisdexamfetamine Dimesylate

Criteria

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.