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Software Treatment for Actively Reducing Severity of ADHD in Adults (STARS ADHD Adult)

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital Treatment
Sponsored by
Akili Interactive Labs, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults 18 years and older
  2. Diagnosis of ADHD combined or inattentive type, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) as confirmed by Mini International Neuropsychiatric Interview (MINI) for Attention - Deficit / Hyperactivity Disorders Studies (Adult) 7.0.2
  3. Stably on or off ADHD medications for ≥4 weeks prior to study enrollment and throughout the primary 6-week study
  4. Stably on or off psychoactive medications for ≥4 weeks prior to study enrollment and throughout the 6-week study
  5. Baseline visit score on the ADHD-RS-IV of ≥ 24
  6. Baseline visit score on the TOVA-ACS score ≤ -1.8
  7. Estimated IQ score ≥80 as assessed by the Kaufmann Brief Intelligence Test, Second Edition (KBIT-II)
  8. Access to and self-report of ability to connect wireless devices to a functional wireless network
  9. Ability to follow written and verbal instructions (English) as assessed by the PI and/or study coordinator
  10. Able to comply with all testing and study requirements
  11. Completion of informed consent form

Exclusion Criteria:

  1. Current controlled or uncontrolled, comorbid psychiatric diagnosis with significant symptoms that in the opinion of the Investigator may confound study data/assessments.
  2. Suicidality assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS)
  3. Motor condition (e.g., physical deformity of the hands/arms) that prevents game playing as reported by the participant or observed by the Investigator.
  4. History of moderate or severe substance use disorder within the last 12 months prior to informed consent
  5. History of seizures (excluding febrile seizures), significant tics, or a current diagnosis of Tourette's Disorder.
  6. Known sensitivity to playing video games, such as photo-sensitive epilepsy, light-headedness, dizziness, nausea, or motion sickness.
  7. Color blindness as detected by Ishihara Color Blindness Test
  8. Positive urine drug screen
  9. Current or recent (3 months prior to screening) history of heavy smoking defined as the equivalent of greater than or equal to a pack of cigarettes a day
  10. Any other medical condition that in the opinion of the Investigator may confound study data/assessments.
  11. Participation in a clinical trial within 3 months prior to screening.
  12. Previous exposure to Akili products within the 6 months prior to study enrollment
  13. Plans to initiate new concomitant medications during the primary study, except for common over the counter (OTC) (e.g., ibuprofen, acetaminophen) and prescription medications (e.g., antibiotics) for minor transient ailments.
  14. Planned initiation of, or significant changes in frequency, of non-pharmacological behavioral therapy during the primary study
  15. Planned initiation of, or significant changes in frequency of, non-pharmacological trainings with the aim to improve cognition by means of game or app-based cognitive trainings or neurofeedback, during the primary study

Sites / Locations

  • Melmed Center
  • CNS Clinical Research Trials
  • Innovative Clinical Research, Inc.
  • Accel Research Sites
  • Behavioral Clinical Research, Inc.
  • Midwest Research Group
  • Alivation Research
  • Center for Psychiatry and Behavioral Medicine, Inc.
  • Hassman Research Institute
  • Albuquerque Neuroscience, Inc.
  • MindPath Care Centers
  • IPS Research
  • FutureSearch Trials
  • Southeast Houston Research, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AKL-T01

Arm Description

Digital treatment

Outcomes

Primary Outcome Measures

To evaluate the efficacy of AKL-T01 as determined by the change in a digitally assessed measure, Test of Variables of Attention (TOVA®) Attention Comparison Score (ACS), of sustained and selective attention, after 6 weeks of treatment with AKL-T01
Test of Variables of Attention (TOVA)-Attention Comparison Score (ACS) of sustained and selective attention. Measures at Day 1 and Exit/Post-Treatment Visit Day 42 TOVA ACS is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. ACS is calculated using the following formula: TOVA ACS = Response Time Z score (Half 1) + d' Z score (Half 2) + Variability Z score (Total) + 1.80 where Response Time is the average time it takes to respond correctly to a target, d' score is a response discriminability score reflecting the ratio of hits to "false alarms", and Variability is a measure of consistency of speed of responding based on the standard deviation of the mean correct response times. A score of less than 0 indicates that the subject had similar performance to a normative ADHD population. A lower score indicates a more severe ADHD profile.

Secondary Outcome Measures

To evaluate the change in ADHD symptoms, as determined by change in the ADHD Rating Scale-IV with adult prompts inattention sub-scale and total scale scores, after 6 weeks of treatment with AKL-T01
Change in the Attention Deficit Hyperactive Disorder (ADHD) Rating Scale-IV inattention sub-scale and total scale scores. Measures taken at Baseline Visit (Day 1) and Exit/Post-Treatment Visit (Day 42). ADHD Rating Scale-IV is a clinician-administered questionnaire. The questionnaire is an 18-item scale that provides a rating of the severity of symptoms for Inattention and Hyperactivity-Impulsivity. The total score is obtained by adding the Inattention and Hyperactivity-Impulsivity subscale raw scores. Each item is rated on a 4-point scale; None (0), mild (1), moderate (2), severe (3). A higher score indicates more severe ADHD symptoms and behaviors.

Full Information

First Posted
December 2, 2021
Last Updated
February 27, 2023
Sponsor
Akili Interactive Labs, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05183919
Brief Title
Software Treatment for Actively Reducing Severity of ADHD in Adults (STARS ADHD Adult)
Official Title
A Single Arm, Adaptive Design, Pivotal Trial to Assess the Efficacy of AKL-T01, a Novel Digital Intervention Designed to Improve Attention, in Adults Diagnosed With Attention Deficit Hyperactive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 29, 2021 (Actual)
Primary Completion Date
January 13, 2023 (Actual)
Study Completion Date
January 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akili Interactive Labs, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effects of the videogame-like digital therapy on attentional functioning and symptoms in Adults diagnosed with ADHD.
Detailed Description
This study is a multi-center, unblinded/non-controlled adaptive design study to evaluate objective attention functioning and ADHD symptoms and impairments in adults with a diagnosis of ADHD (combined or inattentive subtype), stably on or off ADHD medication, after 6 weeks of AKL-T01 treatment. A maximum of 325 total participants from 12-30 sites will be enrolled. During the Screening/baseline, participants will undergo screening to evaluate eligibility for the study. Eligible participants will continue onto baseline procedures in the same visit. Treatment phase (Day 2-42) will involve using the digital therapy at home for each participant. Compliance with treatment/use requirements will be monitored remotely during this phase. An In-Clinic assessment will be completed on Day 42 to assess key outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
223 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AKL-T01
Arm Type
Experimental
Arm Description
Digital treatment
Intervention Type
Other
Intervention Name(s)
Digital Treatment
Intervention Description
AKL-T01 multitasking digital treatment. AKL-T01 multitasking treatment employs perceptual discrimination attention/memory task as well as a continuous motor "driving" task.
Primary Outcome Measure Information:
Title
To evaluate the efficacy of AKL-T01 as determined by the change in a digitally assessed measure, Test of Variables of Attention (TOVA®) Attention Comparison Score (ACS), of sustained and selective attention, after 6 weeks of treatment with AKL-T01
Description
Test of Variables of Attention (TOVA)-Attention Comparison Score (ACS) of sustained and selective attention. Measures at Day 1 and Exit/Post-Treatment Visit Day 42 TOVA ACS is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. ACS is calculated using the following formula: TOVA ACS = Response Time Z score (Half 1) + d' Z score (Half 2) + Variability Z score (Total) + 1.80 where Response Time is the average time it takes to respond correctly to a target, d' score is a response discriminability score reflecting the ratio of hits to "false alarms", and Variability is a measure of consistency of speed of responding based on the standard deviation of the mean correct response times. A score of less than 0 indicates that the subject had similar performance to a normative ADHD population. A lower score indicates a more severe ADHD profile.
Time Frame
Study Day 1 to Study Day 42
Secondary Outcome Measure Information:
Title
To evaluate the change in ADHD symptoms, as determined by change in the ADHD Rating Scale-IV with adult prompts inattention sub-scale and total scale scores, after 6 weeks of treatment with AKL-T01
Description
Change in the Attention Deficit Hyperactive Disorder (ADHD) Rating Scale-IV inattention sub-scale and total scale scores. Measures taken at Baseline Visit (Day 1) and Exit/Post-Treatment Visit (Day 42). ADHD Rating Scale-IV is a clinician-administered questionnaire. The questionnaire is an 18-item scale that provides a rating of the severity of symptoms for Inattention and Hyperactivity-Impulsivity. The total score is obtained by adding the Inattention and Hyperactivity-Impulsivity subscale raw scores. Each item is rated on a 4-point scale; None (0), mild (1), moderate (2), severe (3). A higher score indicates more severe ADHD symptoms and behaviors.
Time Frame
Study Day 1 to Study Day 42
Other Pre-specified Outcome Measures:
Title
Change (Study Day 1 to Study Day 42) in Adult ADHD Quality of Life Questionnaire (AAQoL) total score
Description
Change in the Adult ADHD Quality of Life Questionnaire (AAQoL) total score. Measures taken at Baseline Visit (Day 1) and Exit/Post-Treatment Visit (Day 42). AAQoL has 29 items to assess health-related quality of life during the past two weeks among adults with ADHD. Each item is rated by patients on a five-point Likert scale, Not at all/ Never (1) to Extremely/Very Often (5). The AAQoL has a total score and four subscale scores: Life Productivity, Psychological Health, Life Outlook, Relationships Total and subscale scores are computed by (1) reversing scores for all items except the seven items in the Life Outlook subscale; (2) transforming all item scores to a 0-100 point scale (1=0; 2=25; 3=50; 4=75; 5=100); and (3) summing item scores and dividing by the item count to generate subscale and total scores. The scoring algorithm indicates that the total score can be computed with up to three missing items, and each subscale score can be computed with up to one missing item.
Time Frame
Study Day 1 to Study Day 42
Title
Change (Study Day 1 to Study Day 42) in the Adult ADHD Quality of Life Questionnaire (AAQoL) Adult, subscale score for Life Productivity subscale
Description
Change in the Adult ADHD Quality of Life Questionnaire (AAQoL) subscale score for Life Productivity. Measures taken at Baseline Visit (Day 1) and Exit/Post-Treatment Visit (Day 42). AAQoL has 29 items to assess health-related quality of life during the past two weeks among adults with ADHD. Each item is rated by patients on a five-point Likert scale ranging from Not at all/ Never (1) to Extremely/Very Often (5). The AAQoL has a total score and four subscale scores. The subscale, Life Productivity is 11 items, including getting things done on time, completing projects or tasks, remembering important things, and balancing multiple projects. Subscale scores are computed by (1) reversing scores for all items except the seven items in the Life Outlook subscale; (2) transforming all item scores to a 0-100 point scale (1=0; 2=25; 3=50; 4=75; 5=100); and (3) summing item scores and dividing by the item count to generate subscale scores.
Time Frame
Study Day 1 to Study Day 42
Title
Change (Study Day 1 to Study Day 42) in the Conners' Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S) score
Description
Change in the Conners' Adult ADHD Rating Scales-Self Report: Short Version (CAASRS:S) score. Measures taken at Baseline Visit (Day 1) and Exit/Post-Treatment Visit (Day 42). CAASRS:S is a Likert scale, 26-question questionnaire used to rate a patient's current functioning ability. The scores are computed by 0 = Not at all, never; 1 = Just a little, once in a while; 2 = Pretty much, often; and 3 = Very much, very frequently.
Time Frame
Study Day 1 to Study Day 42
Title
Proportion of responders at end of treatment defined as 30% reduction in total ADHD-Rating Scale-IV score
Description
A proportion of the responders with 30% reduction in the total (ADHD) Rating Scale-IV scores. Measures taken at Baseline Visit (Day 1) and Exit/Post-Treatment Visit (Day 42). ADHD Rating Scale-IV is a clinician-administered questionnaire. The questionnaire is an 18-item scale that provides a rating of the severity of symptoms for Inattention and Hyperactivity-Impulsivity. The total score is obtained by adding the Inattention and Hyperactivity-Impulsivity subscale raw scores. Each item is rated on a 4-point scale; None (0), mild (1), moderate (2), severe (3). A higher score indicates more severe ADHD symptoms and behaviors.
Time Frame
Study Day 1 to Study Day 42
Title
Proportion of responders at end of treatment defined as 8-point change in Adult ADHD Quality of Life Questionnaire (AAQoL)
Description
A proportion of the responders with an 8-point change in the Adult ADHD Quality of Life Questionnaire (AAQoL) score taken at (Day 1) and Exit/Post-Treatment Visit (Day 42). AAQoL has 29 items to assess health-related quality of life during the past two weeks among adults with ADHD. Each item is rated by patients on a five-point Likert scale ranging from Not at all/ Never (1) to Extremely/Very Often (5). The AAQoL yields a total score (based on all 29 items) and four subscale scores. Subscale scores are computed by (1) reversing scores for all items except the seven items in the Life Outlook subscale; (2) transforming all item scores to a 0-100 point scale (1=0; 2=25; 3=50; 4=75; 5=100); and (3) summing item scores and dividing by the item count to generate subscale and total scores. The scoring algorithm indicates that the total score can be computed with up to three missing items, and each subscale score can be computed with up to one missing item.
Time Frame
Study Day 1 to Study Day 42
Title
Change (Study Day 1 to Study Day 42) in TOVA metrics other than ACS, Ex-Gaussian Tau Total
Description
To evaluate changes in the following additional Test of Variables of Attention (TOVA) metrics other than Attention Comparison Score (ACS) - Ex-Gaussian Tau. TOVA is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. TOVA metric evaluated for change is: Ex-Gaussian Tau: The exponential decay (or "right hand tail") of the correct response times, modeled using the Ex-Gaussian distribution. Total refers to entire test (both H1 and H2). H1 refers to the first half of the test where target stimulus is infrequent (1 target to 3.5 non-targets), and H2 represents the second half where target stimulus is frequent (3.5 targets to 1 non-target). Measures at Day 1 and Exit/Post-Treatment Visit Day 42.
Time Frame
Study Day 1 to Study Day 42
Title
Change (Study Day 1 to Study Day 42) in TOVA metrics other than ACS, Commission Errors Standard Score H2
Description
To evaluate changes in the following additional Test of Variables of Attention (TOVA) metrics other than Attention Comparison Score (ACS) - Commission Errors Standard. TOVA is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. TOVA metric evaluated for change is: Commission Errors Standard Score H2: Commission errors are the number of times the patient clicked the microswitch at the incorrect time. H2 represents the second half where target stimulus is frequent (3.5 targets to 1 non-target). Measures at Day 1 and Exit/Post-Treatment Visit Day 42.
Time Frame
Study Day 1 to Study Day 42
Title
Change (Study Day 1 to Study Day 42) in TOVA metrics other than ACS, Response Time Variability Standard Score Total
Description
To evaluate changes in the following additional Test of Variables of Attention (TOVA) metrics other than Attention Comparison Score (ACS) - Response Time Variability Standard Score Total. TOVA is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. TOVA metric evaluated for change is: Response Time Variability Standard Score Total: The standard score for the first standard deviation of the correct response times. Total refers to entire test (both H1 and H2). H1 refers to the first half of the test where target stimulus is infrequent (1 target to 3.5 non-targets), and H2 represents the second half where target stimulus is frequent (3.5 targets to 1 non-target). Measures at Day 1 and Exit/Post-Treatment Visit Day 42.
Time Frame
Study Day 1 to Study Day 42
Title
Change (Study Day 1 to Study Day 42) in TOVA metrics other than ACS, Response Time Mean Standard Score H1
Description
To evaluate changes in the following additional Test of Variables of Attention (TOVA) metrics other than Attention Comparison Score (ACS) - Response Time Mean Standard Score H1. TOVA is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. TOVA metric evaluated for change is: Response Time Mean Standard Score H1:The standard score for the mean response time of the correct responses. H1 refers to the first half of the test where target stimulus is infrequent (1 target to 3.5 non-targets). Measures at Day 1 and Exit/Post-Treatment Visit Day 42.
Time Frame
Study Day 1 to Study Day 42
Title
Change (Study Day 1 to Study Day 42) in TOVA metrics other than ACS, D-Prime Standard Score H2
Description
To evaluate changes in the following additional Test of Variables of Attention (TOVA) metrics other than Attention Comparison Score (ACS) - D-Prime Standard Score H2. TOVA is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. TOVA metric evaluated for change is: D-Prime Standard Score H2: D-Prime score is a response discriminability score reflecting the ratio of hits to false alarms. The measure is derived from Signal Detection Theory and has been shown to help distinguish non-impaired individuals from those diagnosed with attention disorders. The score reflects the accuracy of target (signal) and nontarget (noise) discrimination and can be interpreted as a measure of perceptual sensitivity. H2 represents the second half where target stimulus is frequent (3.5 targets to 1 non-target). Measures at Day 1 and Exit/Post-Treatment Visit Day 42.
Time Frame
Study Day 1 to Study Day 42
Title
Change (Study Day 1 to Study Day 42) in TOVA metrics other than ACS, Omission Errors Standard Score H2
Description
To evaluate changes in the following additional Test of Variables of Attention (TOVA) metrics other than Attention Comparison Score (ACS) - Omission Errors Standard Score H2. TOVA is a comparison of a subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. TOVA metric evaluated for change is: Omission Errors Standard Score H2: Omission Errors are the number of times the patient failed to click the microswitch when the target was presented. H2 represents the second half where target stimulus is frequent (3.5 targets to 1 non-target). Measures at Day 1 and Exit/Post-Treatment Visit Day 42.
Time Frame
Study Day 1 to Study Day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults 18 years and older Diagnosis of ADHD combined or inattentive type, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) as confirmed by Mini International Neuropsychiatric Interview (MINI) for Attention - Deficit / Hyperactivity Disorders Studies (Adult) 7.0.2 Stably on or off ADHD medications for ≥4 weeks prior to study enrollment and throughout the primary 6-week study Stably on or off psychoactive medications for ≥4 weeks prior to study enrollment and throughout the 6-week study Baseline visit score on the ADHD-RS-IV of ≥ 24 Baseline visit score on the TOVA-ACS score ≤ -1.8 Estimated IQ score ≥80 as assessed by the Kaufmann Brief Intelligence Test, Second Edition (KBIT-II) Access to and self-report of ability to connect wireless devices to a functional wireless network Ability to follow written and verbal instructions (English) as assessed by the PI and/or study coordinator Able to comply with all testing and study requirements Completion of informed consent form Exclusion Criteria: Current controlled or uncontrolled, comorbid psychiatric diagnosis with significant symptoms that in the opinion of the Investigator may confound study data/assessments. Suicidality assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS) Motor condition (e.g., physical deformity of the hands/arms) that prevents game playing as reported by the participant or observed by the Investigator. History of moderate or severe substance use disorder within the last 12 months prior to informed consent History of seizures (excluding febrile seizures), significant tics, or a current diagnosis of Tourette's Disorder. Known sensitivity to playing video games, such as photo-sensitive epilepsy, light-headedness, dizziness, nausea, or motion sickness. Color blindness as detected by Ishihara Color Blindness Test Positive urine drug screen Current or recent (3 months prior to screening) history of heavy smoking defined as the equivalent of greater than or equal to a pack of cigarettes a day Any other medical condition that in the opinion of the Investigator may confound study data/assessments. Participation in a clinical trial within 3 months prior to screening. Previous exposure to Akili products within the 6 months prior to study enrollment Plans to initiate new concomitant medications during the primary study, except for common over the counter (OTC) (e.g., ibuprofen, acetaminophen) and prescription medications (e.g., antibiotics) for minor transient ailments. Planned initiation of, or significant changes in frequency, of non-pharmacological behavioral therapy during the primary study Planned initiation of, or significant changes in frequency of, non-pharmacological trainings with the aim to improve cognition by means of game or app-based cognitive trainings or neurofeedback, during the primary study
Facility Information:
Facility Name
Melmed Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
CNS Clinical Research Trials
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Innovative Clinical Research, Inc.
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Accel Research Sites
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Behavioral Clinical Research, Inc.
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Midwest Research Group
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Alivation Research
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Center for Psychiatry and Behavioral Medicine, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Albuquerque Neuroscience, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
MindPath Care Centers
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27606
Country
United States
Facility Name
IPS Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Facility Name
FutureSearch Trials
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Southeast Houston Research, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States

12. IPD Sharing Statement

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Software Treatment for Actively Reducing Severity of ADHD in Adults (STARS ADHD Adult)

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