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

NCT ID: NCT02675400

Last Updated: 2018-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2018-08-31

Brief 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.

Detailed Description

The overarching goal of this research program is to construct and evaluate paternal and familial interventions to improve the trajectory of ADHD outcomes in at-risk young children with ADHD symptoms who have not yet been treated with stimulant medications. These children are at risk for ADHD by virtue of paternal ADHD and maladaptive parenting. 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. The primary outcomes for the fathers will be the Conners Adult ADHD Rating Scale-Self Report and Other Report (CAARS), the clinician completed Clinical Global Impressions-Severity (CGI-S) and the Barkley Functional Impairment rating Scale (BFIS). Secondary outcomes include the Family Routines Questionnaire (FRI), the Alabama Parent Questionnaire (APQ) and the Dyadic Parent-Child Interaction Coding System (DPICS).

Specific Aim 1: To develop screening and recruitment strategies for identifying fathers with ADHD who have young children at risk for ADHD.

Specific Aim 2: To assess the comparative efficacy of treating fathers with LDX (or a different ADHD medication if poor response to LDX) and functional impairment after 8 weeks of treatment.

Hypothesis 1a: LDX will be associated with a greater reduction in paternal ADHD symptoms (CAARS, CAARS-Other Informant) and impairment (CGI-S) than families treated with BPT.

Hypothesis 1 b: BPT will be associated with greater improvement on measures of parenting (e.g. APQ, DPICS) and family functioning (DAS, BFIS) than LDX.

To the investigator's knowledge, this 2.5 year study will be the very first to examine the benefit of identifying and treating fathers with ADHD prior to treating the at-risk child. In addition, to the investigator's knowledge, this is the first study to directly compare the impact of BPT vs. LDX on both father and child outcomes. Thus, the investigator's propose a novel treatment strategy for a not uncommon but difficult to treat patient population: young children who are at risk for ADHD by virtue of their early-onset behavior problems and environmental factors such a poor parenting.

Conditions

Attention Deficit/Hyperactivity Disorder (ADHD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Medication Arm

Vyvanse Arm: 3-week open-label titration beginning at 20 mg Vyvanse (a class II drug), and be increased weekly during the titration period until an optimal response is obtained and then continue for 5 weeks. Optimal response is defined as a clinician Clinical Global Impression-Improvement score (CGI-I) ≤ 2 with minimal associated adverse events. Fathers will remain on optimal dose through the course of the study. In cases of poor tolerability or loss of efficacy the dose can be changed. If an optimal response is not achieved a trial with a long acting methylphenidate will be initiated based upon the Texas algorithm for stimulant medication. The study physician will be available by phone 24 hours/day; participants will be instructed to call with any safety concerns.

Group Type: ACTIVE_COMPARATOR

Vyvanse

Intervention Type: DRUG

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

Methylphenidate

Intervention Type: DRUG

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

Behavioral Parent Training Arm

Behavioral Parent Training (BPT) Arm: Fathers in the BPT group will receive weekly parent training sessions based on the Barkley manual, "Defiant Children, Third Edition". The child participants will also come to several sessions at the clinician's and supervisor's discretion.

Group Type: ACTIVE_COMPARATOR

Behavioral Parent Training

Intervention Type: BEHAVIORAL

Half of the fathers will receive behavioral parent training.

Interventions

Vyvanse

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

Intervention Type: DRUG

Behavioral Parent Training

Half of the fathers will receive behavioral parent training.

Intervention Type: BEHAVIORAL

Methylphenidate

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

Intervention Type: DRUG

Other Intervention Names

lisdexamfetamine dimesylate; BPT; MPH

Eligibility Criteria

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.

• 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.

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Seattle Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mark Stein

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark A Stein, PhD

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Locations

Seattle Children's

Seattle, Washington, United States

Countries

United States

References

Boesen K, Paludan-Muller AS, Gotzsche PC, Jorgensen KJ. Extended-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults. Cochrane Database Syst Rev. 2022 Feb 24;2(2):CD012857. doi: 10.1002/14651858.CD012857.pub2.

Reference Type: DERIVED

PMID: 35201607 (View on PubMed)

Other Identifiers

Fathers Too

Identifier Type: -

Identifier Source: org_study_id