Treatments for Fathers With ADHD and Their At-Risk Children (Fathers Too)

• Status: Completed
• Trial end date: 2018-08-31
• Target enrollment: 0
• Participant gender: Male

Summary

In contrast to mothers with Attention Deficit/Hyperactivity Disorder (ADHD), the impact of paternal ADHD in families and children with ADHD symptoms has not been studied, despite the prevalence of ADHD in males. Thus, the investigators do not know the feasibility, impact on treatment on the family and child, and effects of treating fathers relative to mothers with ADHD. Paternal ADHD is associated with negative parenting and child conduct problems.

The investigators hypothesize that successfully treating parental ADHD in fathers will have a beneficial effects on the family that will extend to the child. Specifically, the investigators believe that stimulant medication ((Lisdexamfetamine (LDX) or a different ADHD medication if poor response to LDX) with fathers will reduce father's ADHD symptoms and improve parenting. Effects of stimulant treatment of fathers will be compared to Behavioral Parent Training (BPT) on parenting, and paternal and child outcomes in fathers with ADHD who have children between the ages of 3 -8.

As in the investigator's previous work, the investigators will bank paternal and child DNA and RNA for later examination of pharmacogenetic and epigenetic effects (i.e. RNA) of stimulant response.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Seattle Children's Hospital
• Treatments: Lisdexamfetamine Dimesylate; Methylphenidate

Criteria

Fathers Inclusion Criteria:

• Sign informed consent

• Be between 21-55 years old (inclusive) at the screening visit

• English-speaking

• At screening (after washout, if required) meet full DSM-IV criteria for ADHD, any subtype

• Current CGI-S-ADHD rating ≥ 4 and < 7.

• Findings on physical exam (PE), laboratory studies, vital signs, and electrocardiogram (ECG) judged to be normal for age with no contraindications for MPH treatment.

• Pulse and blood pressure (BP) within 95% of age and gender mean

• Commit to the entire visit schedule for the study.

• Able to complete all study assessments.

• Fathers with comorbid mood/anxiety disorders which are effectively treated with antidepressants or anti-anxiety agents 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.

Father Exclusion Criteria:

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

• Active 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.

• 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).

• Currently, (or within the past 30 days) receiving stimulant medication for ADHD.

• Father should not seek parent-based interventions during the course of the study, Weeks 1 - 8.

Child Inclusion Criteria:

• Sign assent if older than six.

• Be between the ages of 3-8.

• Symptoms of ADHD (Conners Hyperactivity Index or Attention > 60).

• English speaking.

• No prior treatment with effective doses of stimulants.