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| Name | Class |
|---|---|
| Shire | INDUSTRY |
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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vyvanse (lisdexamphetamine) | Drug | Active ADHD drug, Vyvanse, is administered to mother. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Weeks 8 and 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Parental and Family Functioning | 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. |
Mothers Inclusion Criteria:
Mothers Exclusion Criteria:
Child Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A Stein, PhD | Seattle Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40009046 | Derived | 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. | |
| 32926603 | 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. |
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7 participants didn't meet inclusion criteria, 1 decided not to participate after screening, 2 withdrew due to time commitment issues, 1 had a comorbid psychiatric disorder, 1 had a physical contraindication.
Eligible participants were recruited from the investigators' practices, clinic referrals, online advertisements, and radio advertisements. Participants were enrolled between September 2012 and December 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Maternal Medication Then Additional Maternal Medication | 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 Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. |
| FG001 | Maternal Behavioral Parent Training (BPT) Then Additional BPT | 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. Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training |
| FG002 | 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). Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training |
| FG003 | 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. Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 |
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| Phase 2 |
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We enrolled a total of 53 mother-child dyads (total of 106 participants), 41 dyads were randomized to a treatment arm and completed the baseline visit (total of 82 participants). The number of participants in this section is double that of the participant flow because the dyads are split to accurately analyze characteristics.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 8 and 16 |
|
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.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vyvanse 20 mg | Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. For the mothers that were randomized to medication arm, 20mg was the first dose they received. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appetite Suppression | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Stein | Dept of Psychiatry, University of Washington | 206-987-1161 | mstein42@uw.edu |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
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|
| Behavior Parent Training | Behavioral | Mother is given 8 weeks of individual sessions of behavioral parent training |
|
|
| Baseline, Weeks 8 and 16 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| 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. Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training |
| BG002 | 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). Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training |
| BG003 | 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. Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants. | Count of Participants | Participants |
|
| Race (NIH/OMB) | 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants. | Count of Participants | Participants |
|
| OG001 | Maternal Behavioral Parent Training (BPT) Then Additional BPT | 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. Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training |
| OG002 | 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). Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training |
| OG003 | 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. Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 8 and 16 |
|
|
|
| Other Pre-specified | Parental and Family Functioning | 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. | 6 participants were in the study before this assessment was added. 2 participants did not complete this assessment before they withdrew from the study. 3 participants withdrew from the study after the baseline visit (1 in the medication then medication arm after week 8, 1 in the Medication then BPT arm and 1 in BPT then BPT arm). | Posted | Mean | Standard Deviation | instances observed | Baseline, Weeks 8 and 16 |
|
|
|
| 0 |
| 27 |
| 11 |
| 27 |
| EG001 | Vyvanse 30 mg | Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. For the mothers that were randomized to medication arm, 30mg was offered to the mother if 20mg was not a strong enough dose. | 0 | 22 | 12 | 22 |
| EG002 | Vyvanse 40mg | Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. For the mothers that were randomized to medication arm, 40mg was offered to the mother if 30mg was not a strong enough dose. | 0 | 19 | 12 | 19 |
| EG003 | Vyvanse 50 mg | Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. For the mothers that were randomized to medication arm, 50mg was offered to the mother if 40mg was not a strong enough dose. | 0 | 12 | 5 | 12 |
| EG004 | Vyvanse 60 mg | Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. For the mothers that were randomized to medication arm, 60mg was offered to the mother if 50mg was not a strong enough dose. | 0 | 6 | 4 | 6 |
| EG005 | Vyvanse 70mg | Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. For the mothers that were randomized to medication arm, 70mg was offered to the mother if 60mg was not a strong enough dose. | 0 | 2 | 1 | 2 |
| Irritability | General disorders | Non-systematic Assessment |
|
| Sleep Disturbance or Fatigue | General disorders | Non-systematic Assessment |
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| Jitteriness/Restlessness | General disorders | Non-systematic Assessment |
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| Cardiac Events | Cardiac disorders | Non-systematic Assessment | Includes events such as elevated BP, racing heart, thumping heart, etc. |
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| Illness/Infection | General disorders | Non-systematic Assessment | Includes colds, influenza, upper respiratory infection, urinary tract infection, etc. |
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| Gastrointestinal issues | Gastrointestinal disorders | Non-systematic Assessment | Includes GI slowing, constipation, GERD, stomachaches |
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| Headache | General disorders | Non-systematic Assessment |
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| Hives | General disorders | Non-systematic Assessment |
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| Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment |
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| Dry Mouth | General disorders | Non-systematic Assessment |
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| Increased Menstraul Cramps | General disorders | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | Non-systematic Assessment |
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| Dizziness | General disorders | Non-systematic Assessment |
|
| Diaphoresis | General disorders | Non-systematic Assessment |
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| Tense | General disorders | Non-systematic Assessment |
|
| Scotomata | General disorders | Non-systematic Assessment |
|
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| D005021 |
| Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
|
| Female |
|
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Week 8 |
|
| Week 16 |
|
| Total Negative Parenting |
|