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

NCT02675400 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2018-09-12

No results posted yet for this study

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.

Conditions

  • Attention Deficit/Hyperactivity Disorder (ADHD)

Interventions

DRUG

Vyvanse

Half of the participants (fathers) will be randomized to receive Vyvanse.

BEHAVIORAL

Behavioral Parent Training

Half of the fathers will receive behavioral parent training.

DRUG

Methylphenidate

If Vyvanse is not well tolerated, methylphenidate can be prescribed.

Sponsors & Collaborators

  • Seattle Children's Hospital

    lead OTHER

Principal Investigators

  • Mark A Stein, PhD · Seattle Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02675400 on ClinicalTrials.gov