Sequencing Treatments for Mothers With ADHD and Their At - Risk Children

Study Overview
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Brief Summary
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We hypothesize that successfully treating maternal Attention Deficit Hyperactivity Disorder (ADHD) will have a beneficial effect that extends to the child. We believe that multi-component interventions combining maternal stimulant medication, Lisdexamfetamine (LDX), and Behavioral Parent Training (BPT) will improve parenting, maternal, and child outcomes. In terms of improved parenting, we hypothesize that some mothers may respond well to LDX or BPT alone and therefore may not require multi-modal treatment, whereas others may benefit most from multi-modal treatment

Detailed Description
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The overarching goal of this study is to construct and evaluate an adaptive intervention (i.e., an individualized treatment protocol that is adjusted based on the child-mother dyad's initial response to treatment) to improve the trajectory of ADHD outcomes in at-risk children. 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. Our secondary outcome measure will be whether there was a need for medication for the child over the course of the study. The primary outcome for the mother will be the Conners Adult ADHD Rating Scale (CAARS) Attention Scale and the Clinical Global Impression-Severity scale (CGI-S).

Official Title
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Sequencing Treatments for Mothers With ADHD and Their At - Risk Children

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: Vyvanse (lisdexamphetamine)
* Behavioral: Behavior Parent Training


Participation Criteria
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Eligibility Criteria
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Mothers Inclusion Criteria: Sign informed consent Be between 21-50 years old (inclusive) at the screening visit and English-speaking At screening (after washout, if required) meet full Diagnostic and Statistical Manual (DSM-IV) criteria for ADHD, any subtype Have current CGI-S-ADHD rating > 4 and < 8 Have findings on physical exam (PE), laboratory studies, vital signs, and electrocardiogram (ECG) judged to be normal for age with no contraindications for methylphenidate (MPH) treatment Have pulse and blood pressure (BP) within 95% of age and gender mean Commit to the entire visit schedule for the study Be able to complete all study assessments Women of childbearing potential (not surgically sterile or post-menopausal) must agree to use a medically-accepted contraception method consistently Mothers with comorbid mood/anxiety disorders which are effectively treated with Selective Serotonin Reuptake Inhibitors (SSRIs) 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. Also, the prescribing physician must approve of their participation in the study. Mothers Exclusion Criteria: History of allergic reactions or severe negative response to study medications History of 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 History of or 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) Child Inclusion Criteria: Sign assent if older than 6 Be between the ages of 4-8 symptoms of ADHD (Conners Hyperactivity Index > 60), no prior treatment with effective doses of stimulants, defined as one or more weeks of treatment with adequate doses.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maternal Medication then meds<br>The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to enhanced medication | Drug: Vyvanse (lisdexamphetamine)<br>* Active ADHD drug, Vyvanse, is administered to mother.<br>* Other names: Lisdexamfetamine;|
| Experimental: BPT then continued beh tx<br>The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment. | Behavioral: Behavior Parent Training<br>* Mother is given 8 weeks of individual sessions of behavioral parent training<br>* Other names: BPT;|
| Experimental: Maternal Medication then BPT<br>The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training). | Drug: Vyvanse (lisdexamphetamine)<br>* Active ADHD drug, Vyvanse, is administered to mother.<br>* Other names: Lisdexamfetamine;Behavioral: Behavior Parent Training<br>* Mother is given 8 weeks of individual sessions of behavioral parent training<br>* Other names: BPT;|
| Experimental: BPT then maternal medication<br>The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse. | Drug: Vyvanse (lisdexamphetamine)<br>* Active ADHD drug, Vyvanse, is administered to mother.<br>* Other names: Lisdexamfetamine;Behavioral: Behavior Parent Training<br>* Mother is given 8 weeks of individual sessions of behavioral parent training<br>* Other names: BPT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Behavioral Functioning | Child symptom severity will be assessed using the Clinical Global Impression - Severity (CGI-s) scale. This was collected at Baseline, Week 8 (end of Phase 1) and Week 16 (end of Phase 2). The CGI-S scale summarizes the clinician's impression of the participant's symptom improvement and ranges from 1-7 with 1 representing very much improved and 7 representing very much worse. | Baseline, Weeks 8 and 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Behavioral Functioning | The Clinical Global Impression - Severity (CGI-S) scale will be used. This was collected at Baseline, Week 8 (end of Phase 1) and Week 16 (end of Phase 2). The CGI-S scale summarizes the clinician's impression of the participant's symptom improvement and ranges from 1-7 with 1 representing very much improved and 7 representing very much worse. | Baseline, Weeks 8 and 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mothers, ADHD, Treatment, Child