Attention Deficit Hyperactivity DisorderPhase 4TMFNCT01816074

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

A Phase 4 study testing Vyvanse (lisdexamphetamine) and Behavior Parent Training in people with Attention Deficit Hyperactivity Disorder, run by Seattle Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 50 years, women only
Conditions the study is for: Attention Deficit Hyperactivity Disorder
What is being tested?: Vyvanse (lisdexamphetamine) and Behavior Parent Training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 1 siteUnited States
Study dates: Oct 2012to 1 May 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 50 years
Women only
No healthy volunteers
Adult

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Seattle Children's Hospital
Seattle, Washington, 98105

Other trials in United States

About this study

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

Read the 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
Being tested: Vyvanse (lisdexamphetamine), Behavior Parent Training
Keywords: Mothers, ADHD, Treatment, Child
Medical subject headings: Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vyvanse (lisdexamphetamine)Drug
Also called Lisdexamfetamine
Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent TrainingBehavioural
Also called BPT
Mother is given 8 weeks of individual sessions of behavioral parent training

Study groups in NCT01816074
Study group	Role	What they receive
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 Receives: 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. Receives: 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). Receives: 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. Receives: Drug: Vyvanse (lisdexamphetamine); Behavioral: Behavior Parent Training

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, Weeks 8 and 16

Secondary outcomes (1)

Maternal Behavioral Functioning
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.
Measured: Baseline, Weeks 8 and 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 20121 May 2017

First posted21 Mar 2013 (estimated)
Study startOct 2012
Primary completionOct 2016
Study completion1 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01816074
Sponsor's protocol ID: 2012-0189
Acronym: TMF
Status last verified: Sep 2018
First submitted: 5 Mar 2013
Last updated: 9 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 40009046
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.
PubMed 32926603

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD

All Attention Deficit Hyperactivity Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sequencing Treatments for Mothers With ADHD and Their At - Risk Children
ClinicalTrials.gov ID: NCT01816074
Acronym / sponsor ID: TMF / 2012-0189
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Mothers, ADHD, Treatment, Child
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Seattle Children's HospitalUniversity, hospital or other
Collaborators: Shire
Study start: Oct 2012
Primary completion: Oct 2016 (actual)
Study completion: 1 May 2017 (actual)
First posted: 21 Mar 2013 (estimated)
Results: Posted 18 May 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Maternal Medication then meds	Experimental	Drug: Vyvanse (lisdexamphetamine)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
BPT then continued beh tx	Experimental	Behavioral: Behavior Parent TrainingThe 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.
Maternal Medication then BPT	Experimental	Drug: Vyvanse (lisdexamphetamine), Behavioral: Behavior Parent TrainingThe 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).
BPT then maternal medication	Experimental	Drug: Vyvanse (lisdexamphetamine), Behavioral: Behavior Parent TrainingThe 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.

Who may qualify

Ages: 21 to 50 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vyvanse (lisdexamphetamine)Also: LisdexamfetamineActive ADHD drug, Vyvanse, is administered to mother.	Drug	BPT then maternal medication, Maternal Medication then BPT, Maternal Medication then meds
Behavior Parent TrainingAlso: BPTMother is given 8 weeks of individual sessions of behavioral parent training	Behavioural	BPT then continued beh tx, BPT then maternal medication, Maternal Medication then BPT

Primary outcome

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.

1 secondary outcome

Maternal Behavioral Functioning
Time frame: Baseline, Weeks 8 and 16

Results and safety

Results posted to the registry on 18 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Maternal Medication Then Additional Maternal Medication	11	11
Maternal Behavioral Parent Training (BPT) Then Additional BPT	9	9
Maternal Medication Then BPT	11	10
BPT Then Maternal Medication	10	10

Primary outcome: Child Behavioral Functioning

Time frame: Baseline, Weeks 8 and 16. Mean (Standard Deviation). Unit: units on a scale

Measure	Maternal Medication Then Additional Maternal Medication n = 9	Maternal Behavioral Parent Training (BPT) Then Additional BPT n = 9	Maternal Medication Then BPT n = 9	BPT Then Maternal Medication n = 9
Baseline	4.78 (0.92)	4.56 (1.42)	4.44 (0.96)	4.67 (1.33)
Week 8	4.33 (0.67)	3.75 (1.09)	3.63 (0.99)	3.78 (0.63)
Week 16	4.13 (0.93)	3.67 (1.25)	3.38 (1.22)	3.22 (0.92)

Population analysed: 7 participants had missing data, the Child CGI-S was not collected at any of the study visits for these participants because they completed the study before this measure was added to the protocol.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vyvanse 20 mg	0 of 27 (0%)	11 of 27 (40.7%)	Not reported
Vyvanse 30 mg	0 of 22 (0%)	12 of 22 (54.5%)	Not reported
Vyvanse 40mg	0 of 19 (0%)	12 of 19 (63.2%)	Not reported
Vyvanse 50 mg	0 of 12 (0%)	5 of 12 (41.7%)	Not reported
Vyvanse 60 mg	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
Vyvanse 70mg	0 of 2 (0%)	1 of 2 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40009046Lui 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.
Derived from this study: PubMed 32926603Chronis-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.

Related trials for Attention Deficit Hyperactivity Disorder

Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark A Stein, PhD principal investigator

Seattle Children's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Child Behavioral Functioning (time frame: Baseline, Weeks 8 and 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01816074, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.