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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vyvanse | Drug | Half of the participants (fathers) will be randomized to receive Vyvanse. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Barkley Functional Impairment Rating Scale (BFIS) - Other | Completed by collateral informant. 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. |
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Fathers Inclusion Criteria:
Father Exclusion Criteria:
Child Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A Stein, PhD | Seattle Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's | Seattle | Washington | 98105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35201607 | Derived | 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. |
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participants will receive an study report at the end of the study.
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D013035 | Spasm |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D020879 | Neuromuscular Manifestations |
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| ID | Term |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| D008774 | Methylphenidate |
| C041626 | 5,10-dihydro-5-methylphenazine |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
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| Behavioral Parent Training | Behavioral | Half of the fathers will receive behavioral parent training. |
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| Methylphenidate | Drug | If Vyvanse is not well tolerated, methylphenidate can be prescribed. |
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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. |
| Change from Baseline at 8 Weeks. |
| Family Routines Inventory (FRI) | The FRI is a 26-item parent-report measure that assesses the frequency with which families engage in a broad range of routines. | Change from Baseline at 8 Weeks. |
| Alabama Parenting Questionnaire (APQ) | is a 42-item measure on which parents are asked to indicate the frequency with which they implement the following parenting practices: Corporal Punishment, Inconsistent Discipline, Poor Monitoring/Supervision, Involvement, and Positive Parenting. | Change from Baseline at 8 Weeks. |
| Dyadic Parent-Child Interactions (DPICS) | Parents and children will engage in 3 tasks. | Change from Baseline at 8 Weeks. |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005021 |
| Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |