Trial Outcomes & Findings for Lifestyle Enhancement for ADHD Program (NCT NCT03690674)

NCT ID: NCT03690674

Last Updated: 2022-04-21

Results Overview

Measured by accelerometer worn by participating children

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

Baseline (measured prior to week 1 of Treatment Group) and week 9

Results posted on

2022-04-21

Participant Flow

70 participants consisting of 35 dyads (caregver+child) were initially enrolled in the study. 2 dyads withdrew from the study before the group treatment sessions began.

Participant milestones

Participant milestones
Measure
Caregivers - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Overall Study
STARTED
35
35
Overall Study
COMPLETED
32
32
Overall Study
NOT COMPLETED
3
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lifestyle Enhancement for ADHD Program

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Lifestyle Enhancement for ADHD Program
n=33 Participants
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Age, Continuous
7.6 years
n=39 Participants
Sex: Female, Male
Female
16 Participants
n=39 Participants
Sex: Female, Male
Male
17 Participants
n=39 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
n=39 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
29 Participants
n=39 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=39 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=39 Participants
Race (NIH/OMB)
Asian
1 Participants
n=39 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=39 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=39 Participants
Race (NIH/OMB)
White
25 Participants
n=39 Participants
Race (NIH/OMB)
More than one race
5 Participants
n=39 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=39 Participants
Region of Enrollment
United States
33 participants
n=39 Participants

PRIMARY outcome

Timeframe: Baseline (measured prior to week 1 of Treatment Group) and week 9

Population: Only child participants wore the accelerometer. Number analyzed at post reflects participants who withdrew from study and/or did not complete this measurement.

Measured by accelerometer worn by participating children

Outcome measures

Outcome measures
Measure
Lifestyle Enhancement for ADHD Program
n=34 Participants
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Moderate to Vigorous Physical Activity (MVPA)
Baseline (prior to week 1) MVPA
53.1 Moderate-Vigorous Minutes per day
Standard Deviation 27.7
Moderate to Vigorous Physical Activity (MVPA)
Week 9 MVPA
51.8 Moderate-Vigorous Minutes per day
Standard Deviation 24.4

PRIMARY outcome

Timeframe: Weeks 1 - 9

Population: 66 participants (33 dyads) who wore the Garmin devices.

The length of time (in days) each participant wore the Garmin device as a measure of feasibility

Outcome measures

Outcome measures
Measure
Lifestyle Enhancement for ADHD Program
n=66 Participants
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Garmin Wear Time
49.18 Days
Standard Deviation 14.96

PRIMARY outcome

Timeframe: Weeks 1 - 9

Population: 33 caregivers (children were not part of the Facebook groups). 2 dyads dropped out of the study after consent and before group started.

The amount of contribution to the Facebook page (comments, likes, etc) by each participant is a measure of feasibility

Outcome measures

Outcome measures
Measure
Lifestyle Enhancement for ADHD Program
n=33 Participants
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Number of Facebook Posts
7.91 Facebook Posts
Standard Deviation 18.92

PRIMARY outcome

Timeframe: Week 9

Population: 33 dyads were still enrolled and participating at this timepoint.

Attendance will be taken at the focus group as a measure of study acceptability

Outcome measures

Outcome measures
Measure
Lifestyle Enhancement for ADHD Program
n=33 Participants
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Number of Caregivers With Attendance at the Focus Group
29 Participants

SECONDARY outcome

Timeframe: Baseline to week 9

Population: 28 participant children completed this task.

Measure of executive function completed by the child. Score is time in ms for participant to respond. Lower score is better.

Outcome measures

Outcome measures
Measure
Lifestyle Enhancement for ADHD Program
n=28 Participants
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Stop Signal Reaction Time (SSRT) Task Score
Pre
240.4285714 milliseconds
Standard Deviation 59.77019483
Stop Signal Reaction Time (SSRT) Task Score
Post
244.8214286 milliseconds
Standard Deviation 69.76258871

SECONDARY outcome

Timeframe: Baseline to week 9

Population: 29 children completed this assessment at both pre and post timepoints

Measure of executive function completed by the child. Digit Span Task. Minimum score: 0; Maximum score: 54. Higher score is better outcome.

Outcome measures

Outcome measures
Measure
Lifestyle Enhancement for ADHD Program
n=29 Participants
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Digit Span (DS) Task - Total Score
Pre
9.9 score on a scale
Standard Deviation 3.177
Digit Span (DS) Task - Total Score
Post
10.31 score on a scale
Standard Deviation 2.753

SECONDARY outcome

Timeframe: Change between baseline and week 9

Population: This task was not utilized during the study due to study team decision due to time consideration and burden on participants.

Measure of executive function completed by the child

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change between baseline and week 9

Measure of executive function completed by the parent. Parent rates whether the child displays each behavior never, sometimes, or often. Global Executive Composite Score: Minimum 35; Maximum 90. Higher score indicates better outcome.

Outcome measures

Outcome measures
Measure
Lifestyle Enhancement for ADHD Program
n=30 Participants
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Behavior Rating Inventory of Executive Function (BRIEF)
Pre
71.7 T-Score
Standard Deviation 8.69859
Behavior Rating Inventory of Executive Function (BRIEF)
Post
68.4 T-Score
Standard Deviation 8.00259

SECONDARY outcome

Timeframe: Change between baseline and week 9

Measure of functional impairment completed by the parent. The rating scale measures from 0 to 7, where 0 equals no problem and 7 equals extreme problem. Outcome provided as mean of total raw score. Minimum: 0; Maximum: 100. Higher number indicates higher impairment.

Outcome measures

Outcome measures
Measure
Lifestyle Enhancement for ADHD Program
n=29 Participants
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Impairment Rating Scale (IRS)
Pre
72.2414 score on a scale
Standard Deviation 18.13374
Impairment Rating Scale (IRS)
Post
64.7586 score on a scale
Standard Deviation 18.10417

SECONDARY outcome

Timeframe: Change between baseline and week 9

Measure of parenting completed by the parent. The responses are on a 1-5 scale, 1 equals never and 5 equals always. Outcome provided as total raw score. Minimum: 9; Maximum: 45.Higher number indicates better outcome.

Outcome measures

Outcome measures
Measure
Lifestyle Enhancement for ADHD Program
n=30 Participants
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Alabama Parenting Questionnaire (APQ)
Pre
23.3 score on a scale
Standard Deviation 2.48
Alabama Parenting Questionnaire (APQ)
Post
22.6 score on a scale
Standard Deviation 2.24

SECONDARY outcome

Timeframe: Baseline and week 9

Population: 29 participants that completed measure at both timepoints.

Measure of physical activity, sleep, media use, medication use and complementary/alternative medicine use. Measure reported is the number of Caregivers responding 'yes' to item.

Outcome measures

Outcome measures
Measure
Lifestyle Enhancement for ADHD Program
n=29 Participants
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Health Behaviors Survey
HBS Item - Needs 1:1 supervision (Pre)
13 participants
Health Behaviors Survey
HBS item - Needs 1:1 supervision - (POST)
4 participants
Health Behaviors Survey
HBS Item - Doesn't do well in a group - PRE
7 participants
Health Behaviors Survey
HBS Item - Doesn't do well in a group - POST
4 participants

SECONDARY outcome

Timeframe: Baseline and week 9

Population: 24 participants that completed measure at both timepoints.

The Child's Sleep Habits Questionnaire (pre-school and school-aged children) is a measure of sleep problems completed by the parent. The parent rates each behavior based on their frequency: 'Usually' if something occurs 5 or more times in a week, 'Sometimes' if it occurs 2-4 times in a week, or 'rarely' if something occurs never or 1 times during a week. Parents can also indicate whether or not a sleep habit is a problem by choosing Yes, No, or Not applicable. Total score provided is the sum of all 33 items. Item units are on a scale of 1 -3 points. The Total score range is 33 - 99. The higher the number, the more sleep problems are indicated for the child.

Outcome measures

Outcome measures
Measure
Lifestyle Enhancement for ADHD Program
n=24 Participants
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Child's Sleep Habits Questionnaire (Pre-school and School-aged Children)
Pre
47 units on a scale
Standard Deviation 9.371557339
Child's Sleep Habits Questionnaire (Pre-school and School-aged Children)
Post
44 units on a scale
Standard Deviation 7.541191233

SECONDARY outcome

Timeframe: Change between baseline and week 9

Population: 28 participants that completed measure at both timepoints.

Measure of ADHD symptoms reported by the parent. The scale ranges from 0 to 3 with 0 equaling not true at all and 3 equaling very much true. The Conners t-score range from 0 - 100. The higher the number, the worse the outcome.

Outcome measures

Outcome measures
Measure
Lifestyle Enhancement for ADHD Program
n=28 Participants
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Conners-3 Questionnaire
Connors Inattention - PRE
78.71 Score on a scale
Standard Error 11.346
Conners-3 Questionnaire
Connors Inattention - POST
75.75 Score on a scale
Standard Error 9.721
Conners-3 Questionnaire
Connors - Hyperactivity/Impulsivity - PRE
74.89 Score on a scale
Standard Error 12.968
Conners-3 Questionnaire
Connors - Hyperactivity/Impulsivity - POST
71.68 Score on a scale
Standard Error 11.898
Conners-3 Questionnaire
Connors Aggression/Defiance - PRE
69.21 Score on a scale
Standard Error 16.601
Conners-3 Questionnaire
Connors Aggression/Defiance - POST
63.21 Score on a scale
Standard Error 14.444

SECONDARY outcome

Timeframe: Baseline and week 9

Population: 33 teachers that reported according to their experience with participant in their class.

Pre and Post measures of ADHD symptoms reported by the teacher. The measure items' scale ranges from 0 to 3, with 0 equaling never and 3 equaling very often. The Inattention outcome measure reported is the average number of items (symptoms) in the Inattention Sub-scale of the Vanderbilt that teachers rated their students as 2 or higher on the 0-3 scale. There are 9 items in the Inattention sub-scale, and the range of Inattention Symptoms reported by the teacher is 0-9. The Hyperactive/Impulsive outcome measure reported is the average number of items (symptoms) in the Hyperactive/Impulsive Sub-scale of the Vanderbilt that teachers rated their students as 2 or higher on the 0-3 scale. There are 9 items in the Hyperactive/Impulsive sub-scale, and the range of Hyperactive/Impulsive Symptoms reported by the teacher is 0-9.The higher the number, the more symptoms teachers are reporting.

Outcome measures

Outcome measures
Measure
Lifestyle Enhancement for ADHD Program
n=33 Participants
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Children - Lifestyle Enhancement for ADHD Program
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Teacher Vanderbilt
Vanderbilt Inattention - teacher-report - PRE
4.91 symptoms
Standard Deviation 3.263
Teacher Vanderbilt
Vanderbilt Inattention - teacher-report - POST
3.61 symptoms
Standard Deviation 2.989
Teacher Vanderbilt
Vanderbilt Hyperactive/Impulsive - teacher-report - PRE
3.67 symptoms
Standard Deviation 3.266
Teacher Vanderbilt
Vanderbilt Hyperactive/Impulsive - teacher-report - POST
2.64 symptoms
Standard Deviation 2.988

Adverse Events

Caregivers - Lifestyle Enhancement for ADHD Program

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Children - Lifestyle Enhancement for ADHD Program

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Caregivers - Lifestyle Enhancement for ADHD Program
n=35 participants at risk
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Children - Lifestyle Enhancement for ADHD Program
n=35 participants at risk
There is no comparison/control arm. Lifestyle Enhancement for ADHD Program: The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
Injury, poisoning and procedural complications
Concussion
2.9%
1/35 • Number of events 1 • Adverse event data were collected during the 8 weeks of treatment group. Participants were not monitored/assessed for adverse events outside of the treatment group timeframe.
0.00%
0/35 • Adverse event data were collected during the 8 weeks of treatment group. Participants were not monitored/assessed for adverse events outside of the treatment group timeframe.
Gastrointestinal disorders
Stomach Flu
0.00%
0/35 • Adverse event data were collected during the 8 weeks of treatment group. Participants were not monitored/assessed for adverse events outside of the treatment group timeframe.
5.7%
2/35 • Number of events 2 • Adverse event data were collected during the 8 weeks of treatment group. Participants were not monitored/assessed for adverse events outside of the treatment group timeframe.

Additional Information

Dr. Pooja Tandon

Seattle Children's Research Institute

Phone: 206-884-1130

Results disclosure agreements

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