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

NCT ID: NCT01816074

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2017-05-01

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).

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Vyvanse (lisdexamphetamine)

Intervention Type: DRUG

Active ADHD drug, Vyvanse, is administered to mother.

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.

Group Type: EXPERIMENTAL

Behavior Parent Training

Intervention Type: BEHAVIORAL

Mother is given 8 weeks of individual sessions of behavioral 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).

Group Type: EXPERIMENTAL

Vyvanse (lisdexamphetamine)

Intervention Type: DRUG

Active ADHD drug, Vyvanse, is administered to mother.

Behavior Parent Training

Intervention Type: BEHAVIORAL

Mother is given 8 weeks of individual sessions of behavioral 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.

Group Type: EXPERIMENTAL

Vyvanse (lisdexamphetamine)

Intervention Type: DRUG

Active ADHD drug, Vyvanse, is administered to mother.

Behavior Parent Training

Intervention Type: BEHAVIORAL

Mother is given 8 weeks of individual sessions of behavioral parent training

Interventions

Vyvanse (lisdexamphetamine)

Active ADHD drug, Vyvanse, is administered to mother.

Intervention Type: DRUG

Behavior Parent Training

Mother is given 8 weeks of individual sessions of behavioral parent training

Intervention Type: BEHAVIORAL

Other Intervention Names

Lisdexamfetamine; BPT

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.

• 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.

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: collaborator

Seattle Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mark Stein

Professor/Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark A Stein, PhD

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Locations

Seattle Children's Hospital

Seattle, Washington, United States

Countries

United States

References

Lui JHL, Chronis-Tuscano A, Almirall D, Whitlock KB, French W, Stein MA. Sequencing Stimulant Medication and Behavioral Parent Training in Multiplex ADHD Families: A Pilot SMART. J Clin Psychiatry. 2025 Feb 19;86(1):24m15463. doi: 10.4088/JCP.24m15463.

Reference Type: DERIVED

PMID: 40009046 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32926603 (View on PubMed)

Other Identifiers

2012-0189

Identifier Type: -

Identifier Source: org_study_id