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

NCT02675400 | Completed Phase 4 DMC

• 1 other identifier: Fathers Too
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit/Hyperactivity Disorder (ADHD)

Keywords

ADHD; ADD; Attention Deficit/Hyperactivity Disorder; Attention; Hyperactivity

Outcome Measures

Primary Outcomes (6)

• CGI -S - ADHD rating scale (Father)

  Clinical Global Impression - Severity .

  Change from Screening at 8 weeks.

• Conners Adult ADHD Rating Scale - Self Report (Father)

  This is a 93-item, reliable and valid measure assessing the core features of DSM-IV ADHD, while adding content unique to the adult expression of ADHD

  Change from Screening at 8 weeks.

• Conners Other Report (about Father)

  Completed by collateral informant. The Conners Other Report is a reliable and valid measure assessing the core features of DSM-IV ADHD, while adding content unique to the adult expression of ADHD

  Change from Screening at 8 weeks

• Barkley Functional Impairment Rating Scale (Father)

  The BFIS is a promising measure of impairment associated with adult ADHD, with adequate reliability, criterion validity with other measures of impairment, and normative data for adults. Normative data and reliable change index will allow for assessing functioning in domains relevant to the current proposal (i.e. Home-family, Daily Responsibilities, Child Rearing) as Well as Mean Impairment Score are sensitive to treatment effects.

  Change from Screening at 8 weeks.

• Conners Parent (completed by parent about child)

  Conners Parent Rating Scale that results in factor scores for Oppositional Behavior, Cognitive Problems, and Hyperactivity. There is extensive normative data and evidence of reliability, validity, and clinical utility (Hart, 1999). This will be the primary measure specifically for ADHD and externalizing symptoms.

  Change form Screening at 8 weeks.

• Conners Teacher Rating Scale (completed by teacher about child)

  Conners Teacher Rating Scale that results in factor scores for Oppositional Behavior, Cognitive Problems, and Hyperactivity. There is extensive normative data and evidence of reliability, validity, and clinical utility (Hart, 1999). This will be the primary measure specifically for ADHD and externalizing symptoms.

  Change from Screening at 8 weeks.

Secondary Outcomes (4)

• Barkley Functional Impairment Rating Scale (BFIS) - Other

  Change from Baseline at 8 Weeks.

• Family Routines Inventory (FRI)

  Change from Baseline at 8 Weeks.

• Alabama Parenting Questionnaire (APQ)

  Change from Baseline at 8 Weeks.

• Dyadic Parent-Child Interactions (DPICS)

  Change from Baseline at 8 Weeks.

Study Arms (2)

Medication Arm

ACTIVE COMPARATOR

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.

Drug: Vyvanse; Drug: Methylphenidate

Behavioral Parent Training Arm

ACTIVE COMPARATOR

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.

Behavioral: Behavioral Parent Training

Interventions

Vyvanse DRUG

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

Also known as: lisdexamfetamine dimesylate

Medication Arm

Behavioral Parent Training BEHAVIORAL

Half of the fathers will receive behavioral parent training.

Also known as: BPT

Behavioral Parent Training Arm

Methylphenidate DRUG

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

Also known as: MPH

Medication Arm

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• 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.

  PMID: 35201607 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Spasm

Interventions

Lisdexamfetamine Dimesylate; Methylphenidate; 5,10-dihydro-5-methylphenazine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mark A Stein, PhD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: February 5, 2016
• Study Start: December 1, 2015
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: September 12, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)