Trial · NCT01816074
Sequencing Treatments for Mothers With ADHD and Their At - Risk Children
NCT01816074, Phase 4, Completed, Seattle Children's Hospital; results first posted 2018-05-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sequencing Treatments for Mothers With ADHD and Their At - Risk Children. Trials, record NCT01816074. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01816074
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sequencing Treatments for Mothers With ADHD and Their At - Risk Children
- NCT number
- NCT01816074
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 53 participants, actual
- Lead sponsor
- Seattle Children's Hospital
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Vyvanse (lisdexamphetamine), Behavior Parent Training
- First posted
- 2013-03-21
- Last updated
- 2018-10-09
- Results first posted
- 2018-05-18
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Child Behavioral Functioning | 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. |
| Secondary | Maternal Behavioral Functioning | 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. |
| Other | Parental and Family Functioning | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Child Behavioral Functioning | Baseline, Weeks 8 and 16 | 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. | units on a scale | MEAN |
| SECONDARY | Maternal Behavioral Functioning | Baseline, Weeks 8 and 16 | units on a scale | MEAN | |
| OTHER_PRE_SPECIFIED | Parental and Family Functioning | Baseline, Weeks 8 and 16 | 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). | instances observed | MEAN |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Child Behavioral Functioning | Maternal Medication Then Additional Maternal Medication | Baseline | 4.78 | Standard Deviation 0.92 | units on a scale |
| Child Behavioral Functioning | Maternal Behavioral Parent Training (BPT) Then Additional BPT | Baseline | 4.56 | Standard Deviation 1.42 | units on a scale |
| Child Behavioral Functioning | Maternal Medication Then BPT | Baseline | 4.44 | Standard Deviation 0.96 | units on a scale |
| Child Behavioral Functioning | BPT Then Maternal Medication | Baseline | 4.67 | Standard Deviation 1.33 | units on a scale |
| Child Behavioral Functioning | Maternal Medication Then Additional Maternal Medication | Week 8 | 4.33 | Standard Deviation 0.67 | units on a scale |
| Child Behavioral Functioning | Maternal Behavioral Parent Training (BPT) Then Additional BPT | Week 8 | 3.75 | Standard Deviation 1.09 | units on a scale |
| Child Behavioral Functioning | Maternal Medication Then BPT | Week 8 | 3.63 | Standard Deviation 0.99 | units on a scale |
| Child Behavioral Functioning | BPT Then Maternal Medication | Week 8 | 3.78 | Standard Deviation 0.63 | units on a scale |
| Child Behavioral Functioning | Maternal Medication Then Additional Maternal Medication | Week 16 | 4.13 | Standard Deviation 0.93 | units on a scale |
| Child Behavioral Functioning | Maternal Behavioral Parent Training (BPT) Then Additional BPT | Week 16 | 3.67 | Standard Deviation 1.25 | units on a scale |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1 | STARTED | Maternal Medication Then Additional Maternal Medication | 11 | |
| Phase 1 | STARTED | Maternal Behavioral Parent Training (BPT) Then Additional BPT | 9 | |
| Phase 1 | STARTED | Maternal Medication Then BPT | 11 | |
| Phase 1 | STARTED | BPT Then Maternal Medication | 10 | |
| Phase 1 | COMPLETED | Maternal Medication Then Additional Maternal Medication | 11 | |
| Phase 1 | COMPLETED | Maternal Behavioral Parent Training (BPT) Then Additional BPT | 9 | |
| Phase 1 | COMPLETED | Maternal Medication Then BPT | 10 | |
| Phase 1 | COMPLETED | BPT Then Maternal Medication | 10 | |
| Phase 1 | NOT COMPLETED | Maternal Medication Then Additional Maternal Medication | 0 | |
| Phase 1 | NOT COMPLETED | Maternal Behavioral Parent Training (BPT) Then Additional BPT | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events102
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Appetite Suppression | Gastrointestinal disorders | Vyvanse 20 mg | 5 | 27 | 6 |
| other | Appetite Suppression | Gastrointestinal disorders | Vyvanse 30 mg | 5 | 22 | 9 |
| other | Appetite Suppression | Gastrointestinal disorders | Vyvanse 40mg | 3 | 19 | 3 |
| other | Appetite Suppression | Gastrointestinal disorders | Vyvanse 50 mg | 1 | 12 | 3 |
| other | Appetite Suppression | Gastrointestinal disorders | Vyvanse 60 mg | 3 | 6 | 4 |
| other | Appetite Suppression | Gastrointestinal disorders | Vyvanse 70mg | 1 | 2 | 2 |
| other | Irritability | General disorders | Vyvanse 20 mg | 4 | 27 | 4 |
| other | Irritability | General disorders | Vyvanse 30 mg | 3 | 22 | 3 |
| other | Irritability | General disorders | Vyvanse 40mg | 2 | 19 | 3 |
| other | Irritability | General disorders | Vyvanse 50 mg | 1 | 12 | 1 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vyvanse 20 mg | ||
| Total, all-cause mortality | Vyvanse 30 mg | ||
| Total, all-cause mortality | Vyvanse 40mg | ||
| Total, all-cause mortality | Vyvanse 50 mg | ||
| Total, all-cause mortality | Vyvanse 60 mg | ||
| Total, all-cause mortality | Vyvanse 70mg | ||
| Total, other adverse events | Vyvanse 20 mg | 11 | 27 |
| Total, other adverse events | Vyvanse 30 mg | 12 | 22 |
| Total, other adverse events | Vyvanse 40mg | 12 | 19 |
| Total, other adverse events | Vyvanse 50 mg | 5 | 12 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01816074
GET https://conductscience.org/api/trials/v1/NCT01816074/results?page=2