Trial Outcomes & Findings for Adolescent Interventions to Manage Self-regulation of T1D (AIMS T1D) (NCT NCT03688919)

NCT ID: NCT03688919

Last Updated: 2022-10-07

Results Overview

Behavioral EF will be measured using standard tasks (Forward/Backward Digit Span, Go No Go). In Digit Span, subjects repeat numbers presented aloud in order or reverse order (8 questions of 2 trials each; correct response is 1 point; incorrect or no response is 0 points). Scores are summed for each trial; maximum total raw score is 16 points. In Go No Go, subjects hit a key to respond when they see the 'go' stimulus (presented for 300 ms) but not when they see the no-go stimulus. Go No Go responses are scored based on reaction time (seconds) and accuracy (0-100%). Then, we will generate a composite variable indicating better EF (i.e. correct Digit Span responses, faster/more accurate Go No Go responses) by creating standardized z-scores for each task variable and calculating a mean score. The final variable analyzed will be the composite z-score that represents behavioral EF, scored such that higher scores indicate better EF and with a Z-score of 0 representing the population mean.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 88 participants
• Primary outcome timeframe: baseline and 8 weeks
• Results posted on: 2022-10-07

Participant Flow

Youth with Type 1 Diabetes were recruited from pediatric endocrinology clinics in Michigan.

Participant milestones

Measure	Comparison Adolescents and their families in this group will not receive any of the interventions.	Self-Regulation Intervention This arm will use a computer-based working memory training game (NBack) targeting Executive Functioning and in-person relaxation and biofeedback training targeting Emotion Regulation. As well, adolescents will receive Future Orientation training by being asked to envision and describe future events they are looking forward to, using concrete, vivid descriptive language. Self-Regulation Intervention: The intervention targets Executive Functioning (EF), Emotion Regulation (ER) and Future Orientation (FO). The intervention will occur through home practice and text based reminders and mobile apps to practice techniques. For EF, youth will use the NBack intervention, a computer-based working memory training game. For ER, participants will engage in relaxation and biofeedback activities by completing activities (e.g., modulating breathing to keep heart rate) while wearing sensors. For FO, participants will envision and describe future events they are looking forward to, using concrete, vivid descriptive language. These descriptions will be audio recorded so that the participant can play back the cues at home at specified times of day (e.g., 7am and 3:30PM).
Overall Study STARTED	41	47
Overall Study COMPLETED	38	46
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	Comparison Adolescents and their families in this group will not receive any of the interventions.	Self-Regulation Intervention This arm will use a computer-based working memory training game (NBack) targeting Executive Functioning and in-person relaxation and biofeedback training targeting Emotion Regulation. As well, adolescents will receive Future Orientation training by being asked to envision and describe future events they are looking forward to, using concrete, vivid descriptive language. Self-Regulation Intervention: The intervention targets Executive Functioning (EF), Emotion Regulation (ER) and Future Orientation (FO). The intervention will occur through home practice and text based reminders and mobile apps to practice techniques. For EF, youth will use the NBack intervention, a computer-based working memory training game. For ER, participants will engage in relaxation and biofeedback activities by completing activities (e.g., modulating breathing to keep heart rate) while wearing sensors. For FO, participants will envision and describe future events they are looking forward to, using concrete, vivid descriptive language. These descriptions will be audio recorded so that the participant can play back the cues at home at specified times of day (e.g., 7am and 3:30PM).
Overall Study Lost to Follow-up	2	1
Overall Study withdrawn by study team due to poor data validity	1	0

Baseline Characteristics

Some missing data from this measure could not be analyzed so the total number analyzed differs from the population

Baseline characteristics by cohort

Measure	Comparison n=41 Participants Adolescents and their families in this group will not receive any of the interventions.	Self-Regulation Intervention n=47 Participants This arm will use a computer-based working memory training game (NBack) targeting Executive Functioning and in-person relaxation and biofeedback training targeting Emotion Regulation. As well, adolescents will receive Future Orientation training by being asked to envision and describe future events they are looking forward to, using concrete, vivid descriptive language. Self-Regulation Intervention: The intervention targets Executive Functioning (EF), Emotion Regulation (ER) and Future Orientation (FO). The intervention will occur through home practice and text based reminders and mobile apps to practice techniques. For EF, youth will use the NBack intervention, a computer-based working memory training game. For ER, participants will engage in relaxation and biofeedback activities by completing activities (e.g., modulating breathing to keep heart rate) while wearing sensors. For FO, participants will envision and describe future events they are looking forward to, using concrete, vivid descriptive language. These descriptions will be audio recorded so that the participant can play back the cues at home at specified times of day (e.g., 7am and 3:30PM).	Total n=88 Participants Total of all reporting groups
Age, Categorical <=18 years	41 Participants n=41 Participants	47 Participants n=47 Participants	88 Participants n=88 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=41 Participants	0 Participants n=47 Participants	0 Participants n=88 Participants
Age, Categorical >=65 years	0 Participants n=41 Participants	0 Participants n=47 Participants	0 Participants n=88 Participants
Age, Continuous	15.5 years STANDARD_DEVIATION 1.3 • n=41 Participants	15.4 years STANDARD_DEVIATION 1.5 • n=47 Participants	15.4 years STANDARD_DEVIATION 1.4 • n=88 Participants
Sex: Female, Male Female	20 Participants n=41 Participants	21 Participants n=47 Participants	41 Participants n=88 Participants
Sex: Female, Male Male	21 Participants n=41 Participants	26 Participants n=47 Participants	47 Participants n=88 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=41 Participants	1 Participants n=47 Participants	2 Participants n=88 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=41 Participants	46 Participants n=47 Participants	84 Participants n=88 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=41 Participants	0 Participants n=47 Participants	2 Participants n=88 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=41 Participants	0 Participants n=47 Participants	1 Participants n=88 Participants
Race (NIH/OMB) Asian	0 Participants n=41 Participants	1 Participants n=47 Participants	1 Participants n=88 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants	0 Participants n=47 Participants	0 Participants n=88 Participants
Race (NIH/OMB) Black or African American	1 Participants n=41 Participants	4 Participants n=47 Participants	5 Participants n=88 Participants
Race (NIH/OMB) White	36 Participants n=41 Participants	39 Participants n=47 Participants	75 Participants n=88 Participants
Race (NIH/OMB) More than one race	2 Participants n=41 Participants	2 Participants n=47 Participants	4 Participants n=88 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=41 Participants	1 Participants n=47 Participants	2 Participants n=88 Participants
Region of Enrollment United States	41 Participants n=41 Participants	47 Participants n=47 Participants	88 Participants n=88 Participants
Youth Executive Function (behavioral)	0.00 z-score STANDARD_DEVIATION 0.09 • n=38 Participants • Some missing data from this measure could not be analyzed so the total number analyzed differs from the population	0.01 z-score STANDARD_DEVIATION 0.08 • n=46 Participants • Some missing data from this measure could not be analyzed so the total number analyzed differs from the population	0.00 z-score STANDARD_DEVIATION 0.07 • n=84 Participants • Some missing data from this measure could not be analyzed so the total number analyzed differs from the population
Youth Executive Function (parent/child report)	-0.01 z-score STANDARD_DEVIATION 0.12 • n=40 Participants • Some missing data from this measure could not be analyzed so the total number analyzed differs from the population	0.03 z-score STANDARD_DEVIATION 0.11 • n=47 Participants • Some missing data from this measure could not be analyzed so the total number analyzed differs from the population	0.01 z-score STANDARD_DEVIATION 0.08 • n=87 Participants • Some missing data from this measure could not be analyzed so the total number analyzed differs from the population
Youth Emotion Regulation (parent/child report)	0.08 z-score STANDARD_DEVIATION 0.12 • n=41 Participants	0.02 z-score STANDARD_DEVIATION 0.08 • n=47 Participants	0.05 z-score STANDARD_DEVIATION 0.07 • n=88 Participants
Youth Self Efficacy (parent/child report)	-0.21 z-score STANDARD_DEVIATION 0.12 • n=41 Participants	0.02 z-score STANDARD_DEVIATION 0.11 • n=47 Participants	-0.09 z-score STANDARD_DEVIATION 0.08 • n=88 Participants
Youth Future Orientation (child self report)	-0.06 z-score STANDARD_DEVIATION 0.17 • n=40 Participants • Some missing data from this measure could not be analyzed so the total number analyzed differs from the population	-0.15 z-score STANDARD_DEVIATION 0.15 • n=46 Participants • Some missing data from this measure could not be analyzed so the total number analyzed differs from the population	-0.11 z-score STANDARD_DEVIATION 0.11 • n=86 Participants • Some missing data from this measure could not be analyzed so the total number analyzed differs from the population
Youth Future Orientation (behavioral)	-0.12 z-score STANDARD_DEVIATION 0.11 • n=37 Participants • Some missing data from this measure could not be analyzed so the total number analyzed differs from the population	-0.14 z-score STANDARD_DEVIATION 0.19 • n=44 Participants • Some missing data from this measure could not be analyzed so the total number analyzed differs from the population	-0.13 z-score STANDARD_DEVIATION 0.41 • n=81 Participants • Some missing data from this measure could not be analyzed so the total number analyzed differs from the population
Blood Glucose Monitoring	40 Participants n=40 Participants • Some missing data from this measure could not be analyzed so the total number analyzed differs from the population	43 Participants n=47 Participants • Some missing data from this measure could not be analyzed so the total number analyzed differs from the population	83 Participants n=87 Participants • Some missing data from this measure could not be analyzed so the total number analyzed differs from the population
Insulin Administration Adherence	35 Participants n=36 Participants • Some missing data from this measure could not be analyzed so the total number analyzed differs from the population	34 Participants n=37 Participants • Some missing data from this measure could not be analyzed so the total number analyzed differs from the population	69 Participants n=73 Participants • Some missing data from this measure could not be analyzed so the total number analyzed differs from the population
Self Care Inventory-Revised (Adherence)	-0.20 z-score STANDARD_DEVIATION 0.13 • n=41 Participants	0.05 z-score STANDARD_DEVIATION 0.12 • n=47 Participants	-0.07 z-score STANDARD_DEVIATION 0.09 • n=88 Participants

PRIMARY outcome

Timeframe: baseline and 8 weeks

Population: Some missing data from this measure could not be analyzed so the total number analyzed differs from the population

Behavioral EF will be measured using standard tasks (Forward/Backward Digit Span, Go No Go). In Digit Span, subjects repeat numbers presented aloud in order or reverse order (8 questions of 2 trials each; correct response is 1 point; incorrect or no response is 0 points). Scores are summed for each trial; maximum total raw score is 16 points. In Go No Go, subjects hit a key to respond when they see the 'go' stimulus (presented for 300 ms) but not when they see the no-go stimulus. Go No Go responses are scored based on reaction time (seconds) and accuracy (0-100%). Then, we will generate a composite variable indicating better EF (i.e. correct Digit Span responses, faster/more accurate Go No Go responses) by creating standardized z-scores for each task variable and calculating a mean score. The final variable analyzed will be the composite z-score that represents behavioral EF, scored such that higher scores indicate better EF and with a Z-score of 0 representing the population mean.

Outcome measures

Measure	Comparison n=30 Participants Adolescents and their families in this group will not receive any of the interventions.	Self-Regulation Intervention n=38 Participants This arm will use a computer-based working memory training game (NBack) targeting Executive Functioning and in-person relaxation and biofeedback training targeting Emotion Regulation. As well, adolescents will receive Future Orientation training by being asked to envision and describe future events they are looking forward to, using concrete, vivid descriptive language. Self-Regulation Intervention: The intervention targets Executive Functioning (EF), Emotion Regulation (ER) and Future Orientation (FO). The intervention will occur through home practice and text based reminders and mobile apps to practice techniques. For EF, youth will use the NBack intervention, a computer-based working memory training game. For ER, participants will engage in relaxation and biofeedback activities by completing activities (e.g., modulating breathing to keep heart rate) while wearing sensors. For FO, participants will envision and describe future events they are looking forward to, using concrete, vivid descriptive language. These descriptions will be audio recorded so that the participant can play back the cues at home at specified times of day (e.g., 7am and 3:30PM).
Change From Baseline in Youth Executive Function (Behavioral EF) at 8 Weeks (Z-score)	0.02 z-score Standard Deviation 0.07	-0.02 z-score Standard Deviation 0.06

PRIMARY outcome

Timeframe: baseline and 8 weeks

Population: Some missing data from this measure could not be analyzed so the total number analyzed differs from the population

Youth EF-report will be assessed using parent- and self-report versions of The Behavior Rating Inventory of Executive Functioning, 2nd Edition (BRIEF-2), a standardized EF measure. Items assess ability to control impulses, pay attention, modulate responses, and anticipate events. Three broad indices are calculated (Behavior Regulation, or ability to control behavioral impulses; Emotion Regulation, or ability to control emotional reactions; and Cognitive Regulation, or ability to focus, pay attention, stay organized) and combined to form a Global Executive Composite (GEC) score, which is a standardized score representing overall EF difficulty (range 0-100). Youth and parent GEC scores are averaged to represent overall Global Executive Functioning. The final variable analyzed will be the composite z-score that combines youth- and parent-reported EF, scored such that higher scores indicate poorer EF and with a Z-score of 0 representing the population mean.

Outcome measures

Measure	Comparison n=38 Participants Adolescents and their families in this group will not receive any of the interventions.	Self-Regulation Intervention n=46 Participants This arm will use a computer-based working memory training game (NBack) targeting Executive Functioning and in-person relaxation and biofeedback training targeting Emotion Regulation. As well, adolescents will receive Future Orientation training by being asked to envision and describe future events they are looking forward to, using concrete, vivid descriptive language. Self-Regulation Intervention: The intervention targets Executive Functioning (EF), Emotion Regulation (ER) and Future Orientation (FO). The intervention will occur through home practice and text based reminders and mobile apps to practice techniques. For EF, youth will use the NBack intervention, a computer-based working memory training game. For ER, participants will engage in relaxation and biofeedback activities by completing activities (e.g., modulating breathing to keep heart rate) while wearing sensors. For FO, participants will envision and describe future events they are looking forward to, using concrete, vivid descriptive language. These descriptions will be audio recorded so that the participant can play back the cues at home at specified times of day (e.g., 7am and 3:30PM).
Change From Baseline in Youth Executive Function (EF-report by Parent and Self) at 8 Weeks (Z-score)	0.04 z-score Standard Deviation 0.06	-0.08 z-score Standard Deviation 0.05

PRIMARY outcome

Timeframe: baseline and 8 weeks

Population: Some missing data from this measure could not be analyzed so the total number analyzed differs from the population

ER will be measured using a composite measure of parent- and self-reports on the NIH Toolbox Perceived Stress Survey, a 10-item measure of stress in children (items are summed to indicate greater perceived stress; range: 0-40); youth self-reports of dysregulated affect using a 6-item scale based on the Structured Interview for Disorders of Extreme Stress (SIDES Affect Dysregulation Scale; items are averaged to indicate more affect dysregulation, range: 1-6); and youth reports of emotion experiences on the 20-item Positive and Negative Affect Schedule (PANAS; items are summed to indicate more negative [10 items] and fewer positive experiences [10 items]; range: 10-50). The composite ER measure will be created by standardizing and averaging PSS, SIDES, and PANAS scores. The final variable analyzed will be this composite z-score that represents ER, scored such that higher scores indicate worse ER and with a Z-score of 0 representing the population mean.

Outcome measures

Measure	Comparison n=38 Participants Adolescents and their families in this group will not receive any of the interventions.	Self-Regulation Intervention n=46 Participants This arm will use a computer-based working memory training game (NBack) targeting Executive Functioning and in-person relaxation and biofeedback training targeting Emotion Regulation. As well, adolescents will receive Future Orientation training by being asked to envision and describe future events they are looking forward to, using concrete, vivid descriptive language. Self-Regulation Intervention: The intervention targets Executive Functioning (EF), Emotion Regulation (ER) and Future Orientation (FO). The intervention will occur through home practice and text based reminders and mobile apps to practice techniques. For EF, youth will use the NBack intervention, a computer-based working memory training game. For ER, participants will engage in relaxation and biofeedback activities by completing activities (e.g., modulating breathing to keep heart rate) while wearing sensors. For FO, participants will envision and describe future events they are looking forward to, using concrete, vivid descriptive language. These descriptions will be audio recorded so that the participant can play back the cues at home at specified times of day (e.g., 7am and 3:30PM).
Change From Baseline in Youth Emotion Regulation (ER-report by Parent and Self) at 8 Weeks (Z-score)	-0.10 z-score Standard Deviation 0.05	0.07 z-score Standard Deviation 0.05

PRIMARY outcome

Timeframe: baseline and 8 weeks

Population: Some missing data from this measure could not be analyzed so the total number analyzed differs from the population

Youth self-efficacy is hypothesized to promote future-oriented thinking, and is thus an aspect of Future Orientation that will be measured using a composite of the NIH Toolbox Self-Efficacy parent report form and the self-report form. Both forms consist of 10 items. Participants respond to questions about their child's or their own (in the case of the child) self-efficacy. Mean scores are generated; higher scores are indicative of greater perceived self-efficacy. The final variable analyzed will be the composite z-score that represents youth self-efficacy based on parent and youth report, standardized and averaged and scored such that higher scores indicate better Self-efficacy and with a Z-score of 0 representing the population mean.

Outcome measures

Measure	Comparison n=38 Participants Adolescents and their families in this group will not receive any of the interventions.	Self-Regulation Intervention n=46 Participants This arm will use a computer-based working memory training game (NBack) targeting Executive Functioning and in-person relaxation and biofeedback training targeting Emotion Regulation. As well, adolescents will receive Future Orientation training by being asked to envision and describe future events they are looking forward to, using concrete, vivid descriptive language. Self-Regulation Intervention: The intervention targets Executive Functioning (EF), Emotion Regulation (ER) and Future Orientation (FO). The intervention will occur through home practice and text based reminders and mobile apps to practice techniques. For EF, youth will use the NBack intervention, a computer-based working memory training game. For ER, participants will engage in relaxation and biofeedback activities by completing activities (e.g., modulating breathing to keep heart rate) while wearing sensors. For FO, participants will envision and describe future events they are looking forward to, using concrete, vivid descriptive language. These descriptions will be audio recorded so that the participant can play back the cues at home at specified times of day (e.g., 7am and 3:30PM).
Change From Baseline in Youth Self-Efficacy (Parent- and Self-reported) at 8 Weeks (Z-score)	0.23 z-score Standard Deviation 0.09	0.06 z-score Standard Deviation 0.08

PRIMARY outcome

Timeframe: baseline and 8 weeks

Population: Some missing data from this measure could not be analyzed so the total number analyzed differs from the population

Considering the future and how one's actions can affect future consequences is an aspect of youth Future Orientation (FO) that will be measured using the Consideration of Future Consequences Scale. Youth will answer 14 questions (e.g., "I think about how things would be in days to come, and try to influence those things in my daily behavior") on a 7-point scale ranging from 1=Not at all like me to 7=Neutral. Higher scores indicate a greater consideration of future consequences or forward looking behavior. The final variable analyzed will be a z-score that represents self-reported FO, scored such that higher scores indicate better FO and with a Z-score of 0 representing the population mean.

Outcome measures

Measure	Comparison n=38 Participants Adolescents and their families in this group will not receive any of the interventions.	Self-Regulation Intervention n=46 Participants This arm will use a computer-based working memory training game (NBack) targeting Executive Functioning and in-person relaxation and biofeedback training targeting Emotion Regulation. As well, adolescents will receive Future Orientation training by being asked to envision and describe future events they are looking forward to, using concrete, vivid descriptive language. Self-Regulation Intervention: The intervention targets Executive Functioning (EF), Emotion Regulation (ER) and Future Orientation (FO). The intervention will occur through home practice and text based reminders and mobile apps to practice techniques. For EF, youth will use the NBack intervention, a computer-based working memory training game. For ER, participants will engage in relaxation and biofeedback activities by completing activities (e.g., modulating breathing to keep heart rate) while wearing sensors. For FO, participants will envision and describe future events they are looking forward to, using concrete, vivid descriptive language. These descriptions will be audio recorded so that the participant can play back the cues at home at specified times of day (e.g., 7am and 3:30PM).
Change From Baseline in Youth Future Orientation (Self-report) at 8 Weeks (Z-score)	0.06 z-score Standard Deviation 0.17	0.11 z-score Standard Deviation 0.16

PRIMARY outcome

Timeframe: baseline and 8 weeks

Population: Some missing data from this measure could not be analyzed so the total number analyzed differs from the population

The degree to which one discounts the future is an aspect of youth Future Orientation (FO) that will be objectively measured using 5-trial Delay Discounting Task. Each 5-trial version of this task uses one monetary amount per trial (e.g., $1, 000; $1, 000, 000). Participants are asked on the first trial of the task whether they would prefer to receive that amount in three weeks or half that amount now. On the next trial the question is repeated but with a different time delay according to response on the previous trial. That is, a greater delay is presented on the next trial if the participant chose "now" on the previous trial, whereas a lesser delay is presented if the participant chose the later time on the previous trial. The dependent measure is the steepness of the delay discounting curve. The final variable analyzed will be the z-score that represents this discount rate; higher scores indicate poorer FO and with a Z-score of 0 representing the population mean.

Outcome measures

Measure	Comparison n=28 Participants Adolescents and their families in this group will not receive any of the interventions.	Self-Regulation Intervention n=38 Participants This arm will use a computer-based working memory training game (NBack) targeting Executive Functioning and in-person relaxation and biofeedback training targeting Emotion Regulation. As well, adolescents will receive Future Orientation training by being asked to envision and describe future events they are looking forward to, using concrete, vivid descriptive language. Self-Regulation Intervention: The intervention targets Executive Functioning (EF), Emotion Regulation (ER) and Future Orientation (FO). The intervention will occur through home practice and text based reminders and mobile apps to practice techniques. For EF, youth will use the NBack intervention, a computer-based working memory training game. For ER, participants will engage in relaxation and biofeedback activities by completing activities (e.g., modulating breathing to keep heart rate) while wearing sensors. For FO, participants will envision and describe future events they are looking forward to, using concrete, vivid descriptive language. These descriptions will be audio recorded so that the participant can play back the cues at home at specified times of day (e.g., 7am and 3:30PM).
Change From Baseline in Youth Future Orientation (Objective Measure) at 8 Weeks (Z-score)	0.09 z-score Standard Deviation 0.12	0.03 z-score Standard Deviation 0.11

SECONDARY outcome

Timeframe: baseline and 8 weeks

Population: Some missing data from this measure could not be analyzed so the total number analyzed differs from the population

Change in blood glucose monitoring (BGM) frequency will be assessed by downloading data from the prior two weeks from the adolescent's glucometer. Adherence to BGM is defined as an average of 4 blood glucose measurements/day. Note, we had missing data for the downloads due to changes in clinical care since this measure was proposed (only 30% of the sample had only meters so were not recommended by their provider to download their meters in this way; 70% of the sample had Continuous Glucose Monitors (CGM). Thus, we used the data from self-reported monitoring or CGM use, measured by youth self-report on a Type 1 Diabetes adherence measure administered to all patients in the clinic that has been linked to HbA1c level (Lee et al., 2021).

Outcome measures

Measure	Comparison n=38 Participants Adolescents and their families in this group will not receive any of the interventions.	Self-Regulation Intervention n=46 Participants This arm will use a computer-based working memory training game (NBack) targeting Executive Functioning and in-person relaxation and biofeedback training targeting Emotion Regulation. As well, adolescents will receive Future Orientation training by being asked to envision and describe future events they are looking forward to, using concrete, vivid descriptive language. Self-Regulation Intervention: The intervention targets Executive Functioning (EF), Emotion Regulation (ER) and Future Orientation (FO). The intervention will occur through home practice and text based reminders and mobile apps to practice techniques. For EF, youth will use the NBack intervention, a computer-based working memory training game. For ER, participants will engage in relaxation and biofeedback activities by completing activities (e.g., modulating breathing to keep heart rate) while wearing sensors. For FO, participants will envision and describe future events they are looking forward to, using concrete, vivid descriptive language. These descriptions will be audio recorded so that the participant can play back the cues at home at specified times of day (e.g., 7am and 3:30PM).
Change From Baseline in Number of Participants Conducting Blood Glucose Monitoring at 8 Weeks	38 Participants	42 Participants

SECONDARY outcome

Timeframe: baseline and 8 weeks

Population: Some missing data from this measure could not be analyzed so the total number analyzed differs from the population

Insulin administration adherence is defined as at least 3 short acting insulin boluses/day vs not. This is measured by youth self-report on a Type 1 Diabetes adherence measure administered to all Type 1 Diabetes patients in the clinic and has been linked to Hemoglobin A1c (HbA1c), an indicator of blood glucose level (Lee et al., 2021).

Outcome measures

Measure	Comparison n=32 Participants Adolescents and their families in this group will not receive any of the interventions.	Self-Regulation Intervention n=39 Participants This arm will use a computer-based working memory training game (NBack) targeting Executive Functioning and in-person relaxation and biofeedback training targeting Emotion Regulation. As well, adolescents will receive Future Orientation training by being asked to envision and describe future events they are looking forward to, using concrete, vivid descriptive language. Self-Regulation Intervention: The intervention targets Executive Functioning (EF), Emotion Regulation (ER) and Future Orientation (FO). The intervention will occur through home practice and text based reminders and mobile apps to practice techniques. For EF, youth will use the NBack intervention, a computer-based working memory training game. For ER, participants will engage in relaxation and biofeedback activities by completing activities (e.g., modulating breathing to keep heart rate) while wearing sensors. For FO, participants will envision and describe future events they are looking forward to, using concrete, vivid descriptive language. These descriptions will be audio recorded so that the participant can play back the cues at home at specified times of day (e.g., 7am and 3:30PM).
Change From Baseline in in Number of Participants With Insulin Administration Adherence at 8 Weeks	31 Participants	36 Participants

SECONDARY outcome

Timeframe: baseline and 8 weeks

The Self-Care Inventory Revised (SCI-R) is a 14-item youth- and parent-report measure of multiple T1D self-care adherence behaviors. Items reflect main aspects of the T1D regimen, including: monitoring and recording glucose, administering and adjusting insulin, regulating meals and exercise, and keeping appointments. Respondents report on adherence behaviors on a 5-point scale (1="never do it"; 5="always do this as recommended without fail"; or N/A.). The final variable analyzed will be the composite z-score that represents SCI-R adherence based on youth and parent reports, standardized and averaged and scored such that higher scores indicate better adherence and with a Z-score of 0 representing the population mean.

Outcome measures

Measure	Comparison n=38 Participants Adolescents and their families in this group will not receive any of the interventions.	Self-Regulation Intervention n=46 Participants This arm will use a computer-based working memory training game (NBack) targeting Executive Functioning and in-person relaxation and biofeedback training targeting Emotion Regulation. As well, adolescents will receive Future Orientation training by being asked to envision and describe future events they are looking forward to, using concrete, vivid descriptive language. Self-Regulation Intervention: The intervention targets Executive Functioning (EF), Emotion Regulation (ER) and Future Orientation (FO). The intervention will occur through home practice and text based reminders and mobile apps to practice techniques. For EF, youth will use the NBack intervention, a computer-based working memory training game. For ER, participants will engage in relaxation and biofeedback activities by completing activities (e.g., modulating breathing to keep heart rate) while wearing sensors. For FO, participants will envision and describe future events they are looking forward to, using concrete, vivid descriptive language. These descriptions will be audio recorded so that the participant can play back the cues at home at specified times of day (e.g., 7am and 3:30PM).
Change From Baseline in Self-Care Inventory Revised at 8 Weeks (Z-score)	0.23 z-score Standard Deviation 0.09	0.12 z-score Standard Deviation 0.08

Adverse Events

Comparison

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Self-Regulation Intervention

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Comparison n=41 participants at risk Adolescents and their families in this group will not receive any of the interventions.	Self-Regulation Intervention n=47 participants at risk This arm will use a computer-based working memory training game (NBack) targeting Executive Functioning and in-person relaxation and biofeedback training targeting Emotion Regulation. As well, adolescents will receive Future Orientation training by being asked to envision and describe future events they are looking forward to, using concrete, vivid descriptive language. Self-Regulation Intervention: The intervention targets Executive Functioning (EF), Emotion Regulation (ER) and Future Orientation (FO). The intervention will occur through home practice and text based reminders and mobile apps to practice techniques. For EF, youth will use the NBack intervention, a computer-based working memory training game. For ER, participants will engage in relaxation and biofeedback activities by completing activities (e.g., modulating breathing to keep heart rate) while wearing sensors. For FO, participants will envision and describe future events they are looking forward to, using concrete, vivid descriptive language. These descriptions will be audio recorded so that the participant can play back the cues at home at specified times of day (e.g., 7am and 3:30PM).
Endocrine disorders Diabetic ketoacidosis (DKA)	4.9% 2/41 • Number of events 2 • Study timeframe (8 weeks) regular reporting to the Institutional Review Board (IRB), based on participant report or medical record review	2.1% 1/47 • Number of events 1 • Study timeframe (8 weeks) regular reporting to the Institutional Review Board (IRB), based on participant report or medical record review
Endocrine disorders Hyperglycemia	2.4% 1/41 • Number of events 1 • Study timeframe (8 weeks) regular reporting to the Institutional Review Board (IRB), based on participant report or medical record review	0.00% 0/47 • Study timeframe (8 weeks) regular reporting to the Institutional Review Board (IRB), based on participant report or medical record review

Other adverse events

Measure	Comparison n=41 participants at risk Adolescents and their families in this group will not receive any of the interventions.	Self-Regulation Intervention n=47 participants at risk This arm will use a computer-based working memory training game (NBack) targeting Executive Functioning and in-person relaxation and biofeedback training targeting Emotion Regulation. As well, adolescents will receive Future Orientation training by being asked to envision and describe future events they are looking forward to, using concrete, vivid descriptive language. Self-Regulation Intervention: The intervention targets Executive Functioning (EF), Emotion Regulation (ER) and Future Orientation (FO). The intervention will occur through home practice and text based reminders and mobile apps to practice techniques. For EF, youth will use the NBack intervention, a computer-based working memory training game. For ER, participants will engage in relaxation and biofeedback activities by completing activities (e.g., modulating breathing to keep heart rate) while wearing sensors. For FO, participants will envision and describe future events they are looking forward to, using concrete, vivid descriptive language. These descriptions will be audio recorded so that the participant can play back the cues at home at specified times of day (e.g., 7am and 3:30PM).
Injury, poisoning and procedural complications ER visit	2.4% 1/41 • Number of events 1 • Study timeframe (8 weeks) regular reporting to the Institutional Review Board (IRB), based on participant report or medical record review	0.00% 0/47 • Study timeframe (8 weeks) regular reporting to the Institutional Review Board (IRB), based on participant report or medical record review
Eye disorders cataract surgery	0.00% 0/41 • Study timeframe (8 weeks) regular reporting to the Institutional Review Board (IRB), based on participant report or medical record review	4.3% 2/47 • Number of events 2 • Study timeframe (8 weeks) regular reporting to the Institutional Review Board (IRB), based on participant report or medical record review
General disorders ER visit	4.9% 2/41 • Number of events 2 • Study timeframe (8 weeks) regular reporting to the Institutional Review Board (IRB), based on participant report or medical record review	2.1% 1/47 • Number of events 1 • Study timeframe (8 weeks) regular reporting to the Institutional Review Board (IRB), based on participant report or medical record review

Additional Information

Professor Alison Miller

University of Michigan School of Public Health

Phone: 7346157459

Email: alimill@umich.edu

Results disclosure agreements

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