Trial Outcomes & Findings for Using Computers to Assist in the Diagnosis and Treatment of Attention-deficit/Hyperactivity Disorder (ADHD) (NCT NCT01351064)

NCT ID: NCT01351064

Last Updated: 2016-01-25

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 84 participants
• Primary outcome timeframe: one year
• Results posted on: 2016-01-25

Participant Flow

Participant milestones

Measure	CHICA ADHD Module This arm received The Child Health Improvement through Computer Automation (CHICA) Attention Deficit Hyperactivity Disorder (ADHD) Module CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD	CHICA ADHD Control This arm received CHICA without the ADHD module
Overall Study STARTED	42	42
Overall Study COMPLETED	42	42
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Using Computers to Assist in the Diagnosis and Treatment of Attention-deficit/Hyperactivity Disorder (ADHD)

Baseline characteristics by cohort

Measure	CHICA ADHD Module n=42 Participants This arm received The CHICA ADHD Module CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD	CHICA ADHD Control n=42 Participants This arm received CHICA without the ADHD module	Total n=84 Participants Total of all reporting groups
Age, Categorical <=18 years	42 Participants n=5 Participants	42 Participants n=7 Participants	84 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	31 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants	29 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	9 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: one year

Outcome measures

Measure	CHICA ADHD Module n=42 Participants This arm received The CHICA ADHD Module CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD	CHICA ADHD Control n=42 Participants This arm received CHICA without the ADHD module
Number of Children Diagnosed With ADHD With Structured Diagnostic Assessment	34 number of kids	16 number of kids

SECONDARY outcome

Timeframe: one year

Outcome measures

Measure	CHICA ADHD Module n=42 Participants This arm received The CHICA ADHD Module CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD	CHICA ADHD Control n=42 Participants This arm received CHICA without the ADHD module
Percent of Patients Receiving ADHD Care Component Medication adjusted	45 percentage of participants	33 percentage of participants
Percent of Patients Receiving ADHD Care Component Reassessment of symptoms	50 percentage of participants	33 percentage of participants
Percent of Patients Receiving ADHD Care Component Mental Health Referral	74 percentage of participants	55 percentage of participants
Percent of Patients Receiving ADHD Care Component Mental Health Visit	67 percentage of participants	48 percentage of participants

Adverse Events

CHICA ADHD Module

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CHICA ADHD Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Aaron Carroll

IUSM

Phone: 3172789696

Email: aaecarro@iu.edu

Results disclosure agreements

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