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

NCT01816074 | Completed Phase 4 Results DMC

• 1 other identifier: 2012-0189
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Mothers; ADHD; Treatment; Child

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Maternal Behavioral Functioning

  Baseline, Weeks 8 and 16

Other Outcomes (1)

• Parental and Family Functioning

  Baseline, Weeks 8 and 16

Study Arms (4)

Maternal Medication then meds

EXPERIMENTAL

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)

BPT then continued beh tx

EXPERIMENTAL

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

Maternal Medication then BPT

EXPERIMENTAL

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); Behavioral: Behavior Parent Training

BPT then maternal medication

EXPERIMENTAL

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); Behavioral: Behavior Parent Training

Interventions

Vyvanse (lisdexamphetamine) DRUG

Active ADHD drug, Vyvanse, is administered to mother.

Also known as: Lisdexamfetamine

BPT then maternal medication; Maternal Medication then BPT; Maternal Medication then meds

Behavior Parent Training BEHAVIORAL

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

Also known as: BPT

BPT then continued beh tx; BPT then maternal medication; Maternal Medication then BPT

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• Shire: collaborator

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (2)

• 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.

  PMID: 40009046 DERIVED

• 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.

  PMID: 32926603 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Dr. Mark Stein
• Organization: Dept of Psychiatry, University of Washington

mstein42@uw.edu

206-987-1161

Study Officials

• Mark A Stein, PhD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor/Director

Study Record Dates

• First Submitted: March 5, 2013
• First Posted: March 21, 2013
• Study Start: October 1, 2012
• Primary Completion: October 1, 2016
• Study Completion: May 1, 2017
• Last Updated: October 9, 2018
• Results First Posted: May 18, 2018

Record last verified: 2018-09

Locations

US (1)