Sequencing Treatments for Mothers With ADHD and Their At - Risk Children
Overview
- Phase
- Phase 4
- Intervention
- Vyvanse (lisdexamphetamine)
- Conditions
- Attention Deficit Hyperactivity Disorder
- Sponsor
- Seattle Children's Hospital
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Child Behavioral Functioning
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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).
Investigators
Mark Stein
Professor/Director
Seattle Children's Hospital
Eligibility Criteria
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.
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.
Arms & Interventions
Maternal Medication then meds
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
Intervention: Vyvanse (lisdexamphetamine)
BPT then continued beh tx
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.
Intervention: Behavior Parent Training
Maternal Medication then BPT
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).
Intervention: Vyvanse (lisdexamphetamine)
Maternal Medication then BPT
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).
Intervention: Behavior Parent Training
BPT then maternal medication
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.
Intervention: Vyvanse (lisdexamphetamine)
BPT then maternal medication
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.
Intervention: Behavior Parent Training
Outcomes
Primary Outcomes
Child Behavioral Functioning
Time Frame: Baseline, Weeks 8 and 16
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.
Secondary Outcomes
- Maternal Behavioral Functioning(Baseline, Weeks 8 and 16)