Treatments for Fathers With ADHD and Their At-Risk Children (Fathers Too)
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric, ADHD |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 21 - 55 |
| Updated: | 9/14/2018 |
| Start Date: | December 2015 |
| End Date: | August 31, 2018 |
Treatments for Fathers With Attention Deficit/Hyperactivity Disorder (ADHD) and Their At-Risk Children (Fathers Too)
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.
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.
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.
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.
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.
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