Clinical trial NCT01816074: Sequencing Treatments for Mothers With ADHD and Their At - Risk Children
Official title: Sequencing Treatments for Mothers With ADHD and Their At - Risk Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Mothers
ADHD
Treatment
Child
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Shire
First posted: 2013-03-21
Enrollment: 53
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Child Behavioral Functioning
timeFrame: Baseline, Weeks 8 and 16
Secondary outcomes:
measure: Maternal Behavioral Functioning
timeFrame: Baseline, Weeks 8 and 16
Other outcomes:
measure: Parental and Family Functioning
timeFrame: Baseline, Weeks 8 and 16
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Mark A Stein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chronis-Tuscano A, French W, Strickland J, Sasser T, Gonzalez ENS, Whitlock KB, Stein MA. Acute Effects of Parent Stimulant Medication Versus Behavioral Parent Training on Mothers' ADHD, Parenting Behavior, and At-Risk Children. J Clin Psychiatry. 2020 Sep 8;81(5):19m13173. doi: 10.4088/JCP.19m13173.