Clinical trial NCT02675400: Treatments for Fathers With ADHD and Their At-Risk Children (Fathers Too)
Official title: Treatments for Fathers With Attention Deficit/Hyperactivity Disorder (ADHD) and Their At-Risk Children (Fathers Too)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit/Hyperactivity Disorder (ADHD)
Keywords: ADHD
ADD
Attention Deficit/Hyperactivity Disorder
Attention
Hyperactivity
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2016-02-05
Enrollment: 19
Sex: MALE
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: CGI -S - ADHD rating scale (Father)
timeFrame: Change from Screening at 8 weeks.
measure: Conners Adult ADHD Rating Scale - Self Report (Father)
timeFrame: Change from Screening at 8 weeks.
measure: Conners Other Report (about Father)
timeFrame: Change from Screening at 8 weeks
measure: Barkley Functional Impairment Rating Scale (Father)
timeFrame: Change from Screening at 8 weeks.
measure: Conners Parent (completed by parent about child)
timeFrame: Change form Screening at 8 weeks.
measure: Conners Teacher Rating Scale (completed by teacher about child)
timeFrame: Change from Screening at 8 weeks.
Secondary outcomes:
measure: Barkley Functional Impairment Rating Scale (BFIS) - Other
timeFrame: Change from Baseline at 8 Weeks.
measure: Family Routines Inventory (FRI)
timeFrame: Change from Baseline at 8 Weeks.
measure: Alabama Parenting Questionnaire (APQ)
timeFrame: Change from Baseline at 8 Weeks.
measure: Dyadic Parent-Child Interactions (DPICS)
timeFrame: Change from Baseline at 8 Weeks.
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Mark A Stein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.