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

September 10, 2018 updated by: Mark Stein, Seattle Children's Hospital
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

Study Overview

Status

Completed

Conditions

Intervention / 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).

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Vyvanse (lisdexamphetamine)
Active ADHD drug, Vyvanse, is administered to mother.
Other Names:
  • Lisdexamfetamine
Experimental: 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.
Behavioral: Behavior Parent Training
Mother is given 8 weeks of individual sessions of behavioral parent training
Other Names:
  • BPT
Experimental: 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).
Drug: Vyvanse (lisdexamphetamine)
Active ADHD drug, Vyvanse, is administered to mother.
Other Names:
  • Lisdexamfetamine
Behavioral: Behavior Parent Training
Mother is given 8 weeks of individual sessions of behavioral parent training
Other Names:
  • BPT
Experimental: 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.
Drug: Vyvanse (lisdexamphetamine)
Active ADHD drug, Vyvanse, is administered to mother.
Other Names:
  • Lisdexamfetamine
Behavioral: Behavior Parent Training
Mother is given 8 weeks of individual sessions of behavioral parent training
Other Names:
  • BPT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Weeks 8 and 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal Behavioral Functioning
Time Frame: Baseline, Weeks 8 and 16
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental and Family Functioning
Time Frame: Baseline, Weeks 8 and 16
The Dyadic Parent-Child Interaction Coding System (DPICS) will be used at baseline, week 8, and week 16 to provide an observational measure of positive and negative behaviors of the mother toward the child. Instances of positive (e.g. praise) and negative (e.g. criticism) behaviors are coded by study raters trained to reliability; scores range from 0 to no upper limit. Higher numbers indicate higher instances of the observed behaviors.
Baseline, Weeks 8 and 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seattle Children's Hospital

Collaborators

Shire

Investigators

  • Principal Investigator: Mark A Stein, PhD, Seattle Children's

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

March 5, 2013

First Submitted That Met QC Criteria

March 18, 2013

First Posted (Estimate)

March 21, 2013

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

September 10, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-0189

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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