Trial Outcomes & Findings for Adaptation and Implementation of an ASD Executive Functioning Intervention in Children's Mental Health Services (NCT NCT04295512)

NCT ID: NCT04295512

Last Updated: 2025-02-27

Results Overview

The Acceptability of Intervention Measure (AIM) measure includes four items assessing the acceptability of an intervention. Participants rate the intervention using a 5-point Likert scale (1- Completely Disagree to 5- Completely Agree), with a minimum score of 4 and maximum score of 20 and higher scores indicating higher acceptability. This measure were designed to assess mental health providers' perceptions regarding acceptability of an evidence-based intervention. This measure demonstrate good reliability and validity. Providers trained in Unstuck and On Target completed this measure. Scores are an overall mean score.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 75 participants
• Primary outcome timeframe: 6 months after starting implementation
• Results posted on: 2025-02-27

Participant Flow

Numbers pertaining to those who started and completed don't match the protocol number. Participant numbers in fact exceeded the numbers for protocol enrollment with the exception of Usual Care: Children. Reason for this inconsistency is due to child recruitment at the start of the COVID 19 pandemic.

Participant milestones

Measure	Usual Care: Therapist Community therapists delivering routine care in a community health setting. Note: some therapists enrolled with more than one child.	Unstuck and On Target Therapist Community therapists trained in delivering Unstuck and On Target in a community health setting. Note: some therapists enrolled with more than one child.	Usual Care: Children Children with suspected or diagnosed ASD receiving care with a participating therapist.	Unstuck and On Target: Children Children with suspected or diagnosed ASD receiving care with a participating therapist.
Overall Study STARTED	18	23	12	22
Overall Study COMPLETED	11	16	12	20
Overall Study NOT COMPLETED	7	7	0	2

Reasons for withdrawal

Measure	Usual Care: Therapist Community therapists delivering routine care in a community health setting. Note: some therapists enrolled with more than one child.	Unstuck and On Target Therapist Community therapists trained in delivering Unstuck and On Target in a community health setting. Note: some therapists enrolled with more than one child.	Usual Care: Children Children with suspected or diagnosed ASD receiving care with a participating therapist.	Unstuck and On Target: Children Children with suspected or diagnosed ASD receiving care with a participating therapist.
Overall Study Lack of family response to schedule assessment	0	0	0	2
Overall Study Therapist did not refer eligible family	7	7	0	0

Baseline Characteristics

Overall number represents child participants.

Baseline characteristics by cohort

Measure	Usual Care: Therapists n=11 Participants Community therapists delivering routine care in a community health setting. Note: some therapists enrolled with more than one child.	Unstuck and On Target: Therapists n=16 Participants Community therapists trained in delivering Unstuck and On Target in a community health setting. Note: some therapists enrolled with more than one child.	Usual Care: Children n=12 Participants Children with suspected or diagnosed ASD receiving care with a participating therapist.	Unstuck and On Target: Children n=20 Participants Children with suspected or diagnosed ASD receiving care with a participating therapist.	Total n=59 Participants Total of all reporting groups
Race (NIH/OMB) Race · Asian	2 Participants n=10 Participants • Overall number represents child participants.	2 Participants n=16 Participants • Overall number represents child participants.	3 Participants n=12 Participants • Overall number represents child participants.	0 Participants n=20 Participants • Overall number represents child participants.	7 Participants n=58 Participants • Overall number represents child participants.
Age, Continuous Age	34.07 years STANDARD_DEVIATION 8.1 • n=10 Participants • Total column represents the combined mean of therapist and child ages.	35.69 years STANDARD_DEVIATION 6.1 • n=16 Participants • Total column represents the combined mean of therapist and child ages.	9.37 years STANDARD_DEVIATION 2.37 • n=12 Participants • Total column represents the combined mean of therapist and child ages.	9.43 years STANDARD_DEVIATION 2.46 • n=20 Participants • Total column represents the combined mean of therapist and child ages.	35.07 years STANDARD_DEVIATION 3.2 • n=58 Participants • Total column represents the combined mean of therapist and child ages.
Sex: Female, Male Sex · Female	9 Participants n=10 Participants • Overall number represents child participants.	14 Participants n=16 Participants • Overall number represents child participants.	2 Participants n=12 Participants • Overall number represents child participants.	8 Participants n=20 Participants • Overall number represents child participants.	33 Participants n=58 Participants • Overall number represents child participants.
Sex: Female, Male Sex · Male	1 Participants n=10 Participants • Overall number represents child participants.	2 Participants n=16 Participants • Overall number represents child participants.	10 Participants n=12 Participants • Overall number represents child participants.	12 Participants n=20 Participants • Overall number represents child participants.	25 Participants n=58 Participants • Overall number represents child participants.
Ethnicity (NIH/OMB) Ethnicity · Hispanic or Latino	6 Participants n=10 Participants • Overall number represents child participants.	6 Participants n=16 Participants • Overall number represents child participants.	9 Participants n=12 Participants • Overall number represents child participants.	16 Participants n=20 Participants • Overall number represents child participants.	37 Participants n=58 Participants • Overall number represents child participants.
Ethnicity (NIH/OMB) Ethnicity · Not Hispanic or Latino	4 Participants n=10 Participants • Overall number represents child participants.	10 Participants n=16 Participants • Overall number represents child participants.	3 Participants n=12 Participants • Overall number represents child participants.	4 Participants n=20 Participants • Overall number represents child participants.	21 Participants n=58 Participants • Overall number represents child participants.
Ethnicity (NIH/OMB) Ethnicity · Unknown or Not Reported	0 Participants n=10 Participants • Overall number represents child participants.	0 Participants n=16 Participants • Overall number represents child participants.	0 Participants n=12 Participants • Overall number represents child participants.	0 Participants n=20 Participants • Overall number represents child participants.	0 Participants n=58 Participants • Overall number represents child participants.
Race (NIH/OMB) Race · American Indian or Alaska Native	0 Participants n=10 Participants • Overall number represents child participants.	1 Participants n=16 Participants • Overall number represents child participants.	0 Participants n=12 Participants • Overall number represents child participants.	1 Participants n=20 Participants • Overall number represents child participants.	2 Participants n=58 Participants • Overall number represents child participants.
Race (NIH/OMB) Race · Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants • Overall number represents child participants.	0 Participants n=16 Participants • Overall number represents child participants.	0 Participants n=12 Participants • Overall number represents child participants.	0 Participants n=20 Participants • Overall number represents child participants.	0 Participants n=58 Participants • Overall number represents child participants.
Race (NIH/OMB) Race · Black or African American	0 Participants n=10 Participants • Overall number represents child participants.	1 Participants n=16 Participants • Overall number represents child participants.	0 Participants n=12 Participants • Overall number represents child participants.	1 Participants n=20 Participants • Overall number represents child participants.	2 Participants n=58 Participants • Overall number represents child participants.
Race (NIH/OMB) Race · White	6 Participants n=10 Participants • Overall number represents child participants.	10 Participants n=16 Participants • Overall number represents child participants.	6 Participants n=12 Participants • Overall number represents child participants.	11 Participants n=20 Participants • Overall number represents child participants.	33 Participants n=58 Participants • Overall number represents child participants.
Race (NIH/OMB) Race · More than one race	2 Participants n=10 Participants • Overall number represents child participants.	2 Participants n=16 Participants • Overall number represents child participants.	3 Participants n=12 Participants • Overall number represents child participants.	7 Participants n=20 Participants • Overall number represents child participants.	14 Participants n=58 Participants • Overall number represents child participants.
Race (NIH/OMB) Race · Unknown or Not Reported	0 Participants n=10 Participants • Overall number represents child participants.	0 Participants n=16 Participants • Overall number represents child participants.	0 Participants n=12 Participants • Overall number represents child participants.	0 Participants n=20 Participants • Overall number represents child participants.	0 Participants n=58 Participants • Overall number represents child participants.
Region of Enrollment United States	11 Participants n=11 Participants	16 Participants n=16 Participants	12 Participants n=12 Participants	20 Participants n=20 Participants	59 Participants n=59 Participants
Child-Baseline Measures Child- Social Responsiveness Scale, Baseline T Scores	—	—	74.17 units on a scale STANDARD_DEVIATION 12.10 • n=12 Participants • Baseline measures were only collected for enrolled children and not for therapists. Thus, therapist values are 0	74.50 units on a scale STANDARD_DEVIATION 9.81 • n=20 Participants • Baseline measures were only collected for enrolled children and not for therapists. Thus, therapist values are 0	74.37 units on a scale STANDARD_DEVIATION 10.54 • n=32 Participants • Baseline measures were only collected for enrolled children and not for therapists. Thus, therapist values are 0
Child-Baseline Measures Child- Wechsler Abbreviated Scale of Intelligence 2nd Edition, Baseline Standard Scores	—	—	92.42 units on a scale STANDARD_DEVIATION 13.42 • n=12 Participants • Baseline measures were only collected for enrolled children and not for therapists. Thus, therapist values are 0	83.63 units on a scale STANDARD_DEVIATION 17.99 • n=20 Participants • Baseline measures were only collected for enrolled children and not for therapists. Thus, therapist values are 0	87.03 units on a scale STANDARD_DEVIATION 16.71 • n=32 Participants • Baseline measures were only collected for enrolled children and not for therapists. Thus, therapist values are 0

PRIMARY outcome

Timeframe: 6 months after starting implementation

Population: Measure only administered to Therapist intervention (Unstuck and On Target) group

The Acceptability of Intervention Measure (AIM) measure includes four items assessing the acceptability of an intervention. Participants rate the intervention using a 5-point Likert scale (1- Completely Disagree to 5- Completely Agree), with a minimum score of 4 and maximum score of 20 and higher scores indicating higher acceptability. This measure were designed to assess mental health providers' perceptions regarding acceptability of an evidence-based intervention. This measure demonstrate good reliability and validity. Providers trained in Unstuck and On Target completed this measure. Scores are an overall mean score.

Outcome measures

Measure	Therapists- Unstuck and On Target n=14 Participants Community therapists trained and delivering Unstuck and On Target to participant children	Unstuck and On Target Therapists randomized to receive training and deliver Unstuck and On Target
Acceptability of Intervention Measure	4.58 score on a scale Standard Deviation 0.46	—

PRIMARY outcome

Timeframe: 6 months after starting implementation

Population: Measure only administered to Therapist intervention (Unstuck and On Target) group

The Intervention Appropriateness Measure (IAM) measure includes four items assessing the appropriateness of an intervention. Participants rate the intervention using a 5-point Likert scale (1- Completely Disagree to 5- Completely Agree), with a minimum score of 4 and maximum score of 20 and higher scores indicating higher appropriateness. This measure was designed to assess mental health providers' perceptions regarding appropriateness of an evidence-based intervention. This measure demonstrate good reliability and validity. Providers trained in Unstuck and On Target completed this measure. Scores are an overall mean score.

Outcome measures

Measure	Therapists- Unstuck and On Target n=12 Participants Community therapists trained and delivering Unstuck and On Target to participant children	Unstuck and On Target Therapists randomized to receive training and deliver Unstuck and On Target
Intervention Appropriateness Measure	4.62 score on a scale Standard Deviation 0.47	—

PRIMARY outcome

Timeframe: 6 months after starting implementation

Population: Measure only administered to Therapist intervention (Unstuck and On Target) group

The Feasibility of Intervention Measure (FIM) measure includes 4 items assessing the feasibility of an intervention. Participants rate the intervention using a 5-point Likert scale (1- Completely Disagree to 5- Completely Agree), with a minimum score of 4 and maximum score of 20 and higher scores indicating higher feasibility. This measure was designed to assess mental health providers' perceptions regarding feasibility of an evidence-based intervention. This measure demonstrate good reliability and validity. Providers trained in Unstuck and On Target completed this measure. Scores are an overall mean score.

Outcome measures

Measure	Therapists- Unstuck and On Target n=12 Participants Community therapists trained and delivering Unstuck and On Target to participant children	Unstuck and On Target Therapists randomized to receive training and deliver Unstuck and On Target
Feasibility of Intervention Measure	4.5 score on a scale Standard Deviation 0.61	—

PRIMARY outcome

Timeframe: A single, averaged value of all fidelity scores has been calculated. Average fidelity represents scores over the course of 6 months of therapist implementation. Table rows represent different aspects of fidelity that were scored.

Population: Community therapists randomized to either usual care or intervention condition working with youth clients with an autism spectrum disorder.

Provider adherence or fidelity to the Unstuck and On Target intervention will be measured through observational coding of provider in-session behaviors using the fidelity measure developed as part of the Unstuck and On Target intervention. Observers rate the provider's use of Unstuck and On Target on 9 components, using a 5-point (1 to 5) Likert scale, with higher scores indicating higher fidelity.

For this report, a single, averaged value of all fidelity scores has been calculated per component.

Outcome measures

Measure	Therapists- Unstuck and On Target n=11 Participants Community therapists trained and delivering Unstuck and On Target to participant children	Unstuck and On Target n=16 Participants Therapists randomized to receive training and deliver Unstuck and On Target
Average of Provider Fidelity Throughout Implementation Period Home Practice Review	1.36 score on a scale Standard Deviation 0.56	3.26 score on a scale Standard Deviation 1.42
Average of Provider Fidelity Throughout Implementation Period Content Delivery	1.44 score on a scale Standard Deviation 0.84	4.74 score on a scale Standard Deviation 0.61
Average of Provider Fidelity Throughout Implementation Period Use of Visuals	2.10 score on a scale Standard Deviation 1.13	4.64 score on a scale Standard Deviation 0.66
Average of Provider Fidelity Throughout Implementation Period Use of Handouts	1.57 score on a scale Standard Deviation 0.82	4.70 score on a scale Standard Deviation 0.76
Average of Provider Fidelity Throughout Implementation Period Use of Vocabulary	1.75 score on a scale Standard Deviation 1.00	4.47 score on a scale Standard Deviation 0.67
Average of Provider Fidelity Throughout Implementation Period Goal, Why, Plan, Do, Check	1.25 score on a scale Standard Deviation 0.77	4.18 score on a scale Standard Deviation 1.05
Average of Provider Fidelity Throughout Implementation Period Models Skills (Flexibility, planning)	2.47 score on a scale Standard Deviation 0.78	3.95 score on a scale Standard Deviation 0.79
Average of Provider Fidelity Throughout Implementation Period Use of More Positive Praise than Correction	4.63 score on a scale Standard Deviation 0.44	4.79 score on a scale Standard Deviation 0.57
Average of Provider Fidelity Throughout Implementation Period Use of Parent Engagement Strategies	3.27 score on a scale Standard Deviation 1.37	4.00 score on a scale Standard Deviation 1.13

PRIMARY outcome

Timeframe: At baseline and 6 months post-implementation.

Population: Children with suspected or diagnosed ASD receiving care with a participating therapist.

Child Behavior Checklist (CBCL) is a parent-report measure of child problem behavior. The CBCL is divided into three broadband scales (Internalizing, Externalizing, and Total Problem Scores) and several associate subscale scores. For this study, only the broadband scales were utilized for analyses. Scores are represented as T-scores with a population mean of 50 with standard deviation of 10 and ranges from 30 (minimum) to 95 (maximum. Higher scores reflect more mental health symptoms. The values reported below represent the mean change in the T-scores from the Total, Internalizing, and Externalizing T-Scores from baseline to 6 months post intervention for each condition group. Negative values represent an overall decrease in symptoms (better outcome) while positive values representing an increase in problem behaviors (worse outcome) from baseline to post when looking at the condition groups as a whole.

Outcome measures

Measure	Therapists- Unstuck and On Target n=12 Participants Community therapists trained and delivering Unstuck and On Target to participant children	Unstuck and On Target n=20 Participants Therapists randomized to receive training and deliver Unstuck and On Target
Child Behavior Checklist Change in Total Problem Score	-4.54 units on a scale Standard Deviation 6.22	-2.33 units on a scale Standard Deviation 4.53
Child Behavior Checklist Change in Internalizing Behavior Score	-2.64 units on a scale Standard Deviation 6.38	-1.67 units on a scale Standard Deviation 4.17
Child Behavior Checklist Change in Externalizing Behavior Score	-5.36 units on a scale Standard Deviation 5.35	-1.87 units on a scale Standard Deviation 6.97

SECONDARY outcome

Timeframe: At baseline and 6 months post-implementation.

Population: Children with suspected or diagnosed ASD receiving care with a participating therapist.

The Eyberg Child Behavior Inventory is a 36 item questionnaire of child behavior. Caregivers of participating youth completed the questionnaire to assess their perceptions of their child's disruptive behaviors.

The Eyberg Child Behavior Inventory Intensity Scale score measures the frequency of a child's behavioral problems and ranges from 36 (minimum value) to 352 (maximum). A score of 127 or higher is considered to be in the clinical range.

The values reported below represent the mean change in the average T-score from baseline to 6 months post intervention for each condition group.

Negative values represent an overall decrease in problem behaviors (better outcome) while positive values representing an increase in problem behaviors (worse outcome) from baseline to post when looking at the condition groups as a whole.

Outcome measures

Measure	Therapists- Unstuck and On Target n=12 Participants Community therapists trained and delivering Unstuck and On Target to participant children	Unstuck and On Target n=20 Participants Therapists randomized to receive training and deliver Unstuck and On Target
Eyberg Child Behavior Inventory	-7.09 units on a scale Standard Deviation 8.47	1.85 units on a scale Standard Deviation 9.53

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline and 6 months post-implementation.

Population: Children with suspected or diagnosed ASD receiving care with a participating therapist.

The Wechsler Abbreviated Scale of Intelligence Second Edition, is a brief measure of intelligence. We administered the Block Design subscale, a timed visual construction task that measures changes in nonverbal reasoning ability by assessing an individual's capacity to analyze and synthesize abstract visual stimuli, demonstrating visual-spatial skills, and coordinating visual perception with motor actions to replicate geometric patterns using colored blocks.The subtest is scored by converting the raw scores into scale scores using standardized norms. Scores range from 1 (minimum) to 19 (maximum) with an average of 10. Values below represent the change in subscale scaled scores from baseline to post-intervention for participating children. Negative values represent an overall decrease in nonverbal reasoning ability (worse outcome) while positive values represent and overall increase in nonverbal reasoning ability (better outcome).

Outcome measures

Measure	Therapists- Unstuck and On Target n=12 Participants Community therapists trained and delivering Unstuck and On Target to participant children	Unstuck and On Target n=20 Participants Therapists randomized to receive training and deliver Unstuck and On Target
Wechsler Abbreviated Scale of Intelligence Second Edition- Block Design Subscale	5.18 units on a scale Standard Deviation 7.99	.79 units on a scale Standard Deviation 6.29

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline and 6 months post-implementation.

Population: Children with suspected or diagnosed ASD receiving care with a participating therapist.

The Executive Functioning Challenge Task deliberately tests a child's ability to utilize key executive functions like planning and flexibility by presenting scenarios that reveal potential areas of difficulty in their executive functioning skills. The test yields Flexibility and Planning raw scores with a minimum of 0 and maximum of 8. Higher scores indicate greater impairment in executive functioning. A total executive functioning raw score is also calculated as the sum of planning and flexibility scores.

Values below represent the change in average raw scores from baseline to post-intervention for participating children.

Negative scores represent an overall decrease in executive functioning impairment (better outcome) while positive scores representing an increase in executive functioning impairment (worse outcome) from baseline to post when looking at the condition groups as a whole.

Outcome measures

Measure	Therapists- Unstuck and On Target n=12 Participants Community therapists trained and delivering Unstuck and On Target to participant children	Unstuck and On Target n=20 Participants Therapists randomized to receive training and deliver Unstuck and On Target
Executive Functioning Challenge Task Change in Executive Functioning Total Score	-.91 units on a scale Standard Deviation 4.01	-3.00 units on a scale Standard Deviation 2.80
Executive Functioning Challenge Task Change in Planning Score	-0.09 units on a scale Standard Deviation 1.81	-2.21 units on a scale Standard Deviation 1.97
Executive Functioning Challenge Task Change in Flexibility Score	-.82 units on a scale Standard Deviation 2.93	-0.79 units on a scale Standard Deviation 1.63

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline and 6 months post-implementation.

Population: Children with suspected or diagnosed ASD receiving care with a participating therapist.

The Behavior Rating Inventory of Executive Function- Second Edition is a 63-item rating scale completed by caregivers to assess executive function impairment in children. T scores have a population mean of 50 and standard deviation of 10, with a minimum score of 30 and maximum score of 95. Scales assessed included the Behavioral Regulation Index, Emotion Regulation Index and Cognitive Regulation Index, together forming an overall composite score, the Global Executive Composite. Values below represent the change in T-scores scores from baseline to post-intervention for participating children. T scores at or above 70 are considered clinically significant.

Scores represent the change in T scores from baseline to post. Negative values represent decrease in impairment (better outcome) while positive scores representing an increase in impairment (worse outcome) from baseline to post when looking at the condition groups as a whole.

Outcome measures

Measure	Therapists- Unstuck and On Target n=12 Participants Community therapists trained and delivering Unstuck and On Target to participant children	Unstuck and On Target n=20 Participants Therapists randomized to receive training and deliver Unstuck and On Target
Behavior Rating Inventory of Executive Function Second Edition Change in Behavioral Regulation Index T-Score	-2.82 units on a scale Standard Deviation 8.94	-3.54 units on a scale Standard Deviation 5.39
Behavior Rating Inventory of Executive Function Second Edition Change in Emotion Regulation Index T-Score	-2.82 units on a scale Standard Deviation 10.42	-0.31 units on a scale Standard Deviation 6.96
Behavior Rating Inventory of Executive Function Second Edition Change in Cognitive Regulation Index T-Score	-1.55 units on a scale Standard Deviation 7.09	-2.62 units on a scale Standard Deviation 7.68
Behavior Rating Inventory of Executive Function Second Edition Change in Global Executive Composite T-Score	-2.82 units on a scale Standard Deviation 7.43	-2.46 units on a scale Standard Deviation 6.12

Adverse Events

Usual Care: Therapists

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Unstuck and On Target: Therapists

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care: Children

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Unstuck and On Target: Children

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Usual Care: Therapists n=18 participants at risk Community therapists delivering routine care to participant children with no training in Unstuck and on Target	Unstuck and On Target: Therapists n=23 participants at risk Community therapists delivering Unstuck and On Target to participant children	Usual Care: Children n=12 participants at risk Children with suspected or diagnosed ASD receiving care with a participating therapist.	Unstuck and On Target: Children n=22 participants at risk Children with suspected or diagnosed ASD receiving care with a participating therapist.
Psychiatric disorders No Adverse Events were observed during the course of the study	0.00% 0/18 • Adverse events data monitored throughout the 2 year study. Broader oversight for adverse events was provided by a Data Safety and Monitoring Committee (DSMB) selected before data collection began. The DSMB met repeatedly during the study at an average of 2 times a year through study completion (average of 4 meetings over the 2 year duration of the study). Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/23 • Adverse events data monitored throughout the 2 year study. Broader oversight for adverse events was provided by a Data Safety and Monitoring Committee (DSMB) selected before data collection began. The DSMB met repeatedly during the study at an average of 2 times a year through study completion (average of 4 meetings over the 2 year duration of the study). Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/12 • Adverse events data monitored throughout the 2 year study. Broader oversight for adverse events was provided by a Data Safety and Monitoring Committee (DSMB) selected before data collection began. The DSMB met repeatedly during the study at an average of 2 times a year through study completion (average of 4 meetings over the 2 year duration of the study). Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/22 • Adverse events data monitored throughout the 2 year study. Broader oversight for adverse events was provided by a Data Safety and Monitoring Committee (DSMB) selected before data collection began. The DSMB met repeatedly during the study at an average of 2 times a year through study completion (average of 4 meetings over the 2 year duration of the study). Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.

Additional Information

Kelsey Dickson

San Diego State University

Phone: (619) 594-5380

Email: kdickson@sdsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place