Trial Outcomes & Findings for Improving the Academic Performance of First-Grade Students With Reading and Math Difficulty (NCT NCT03991234)
NCT ID: NCT03991234
Last Updated: 2026-03-23
Results Overview
Students read aloud letters followed by simple words followed by words of increasing difficulty. Test ends when after six incorrect responses. Student's score is the number of correct responses.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
385 participants
Primary outcome timeframe
an average of 25 weeks
Results posted on
2026-03-23
Participant Flow
Initial screening took place in first grade classrooms. All students in the classroom whose parents had consented to the study were administered a math screening test. Students scoring at or below the 25th percentile moved to the individually administered second stage of screening. Students who scored below the 25th percentile on the reading test and who scored at or above the 7th percentile on the test of cognitive performance were eligible for the project.
Students who met the eligibility criteria were pretested. After pretesting, the number of students needed for enrollment were randomly selected from the group of students with complete pretest data. Those students were subsequently randomly assigned to the four treatment groups.
Participant milestones
| Measure |
Coordinated Reading and Math Intervention
Coordinated intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction addressing similar skills as those addressed in the reading intervention arm \& similar skills as the math intervention arm.
|
Reading Intervention
Reading intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction designed to build skill on letter-sound associations, decoding, sight words, \& contextualized reading.
|
Math Intervention
Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge, counting strategies, and arithmetic skill.
|
Business-as-usual Control
Participation in the school's typical reading and math classroom instruction and, if designated by the school, its supplemental program.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
96
|
96
|
96
|
97
|
|
Overall Study
COMPLETED
|
67
|
73
|
74
|
78
|
|
Overall Study
NOT COMPLETED
|
29
|
23
|
22
|
19
|
Reasons for withdrawal
| Measure |
Coordinated Reading and Math Intervention
Coordinated intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction addressing similar skills as those addressed in the reading intervention arm \& similar skills as the math intervention arm.
|
Reading Intervention
Reading intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction designed to build skill on letter-sound associations, decoding, sight words, \& contextualized reading.
|
Math Intervention
Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge, counting strategies, and arithmetic skill.
|
Business-as-usual Control
Participation in the school's typical reading and math classroom instruction and, if designated by the school, its supplemental program.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
29
|
23
|
22
|
19
|
Baseline Characteristics
Improving the Academic Performance of First-Grade Students With Reading and Math Difficulty
Baseline characteristics by cohort
| Measure |
Coordinated Reading and Math Intervention
n=67 Participants
Coordinated intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction addressing similar skills as those addressed in the reading intervention arm \& similar skills as the math intervention arm.
|
Reading Intervention
n=73 Participants
Reading intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction designed to build skill on letter-sound associations, decoding, sight words, \& contextualized reading.
|
Math Intervention
n=74 Participants
Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge, counting strategies, and arithmetic skill.
|
Business-as-usual Control
n=78 Participants
Participation in the school's typical reading and math classroom instruction and, if designated by the school, its supplemental program.
|
Total
n=292 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
6.49 Years
STANDARD_DEVIATION .33 • n=10 Participants
|
6.57 Years
STANDARD_DEVIATION .38 • n=8 Participants
|
6.49 Years
STANDARD_DEVIATION .36 • n=18 Participants
|
6.56 Years
STANDARD_DEVIATION .37 • n=158 Participants
|
6.53 Years
STANDARD_DEVIATION .36 • n=3 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=10 Participants
|
40 Participants
n=8 Participants
|
43 Participants
n=18 Participants
|
39 Participants
n=158 Participants
|
165 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=10 Participants
|
33 Participants
n=8 Participants
|
31 Participants
n=18 Participants
|
39 Participants
n=158 Participants
|
127 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=158 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=10 Participants
|
31 Participants
n=8 Participants
|
20 Participants
n=18 Participants
|
29 Participants
n=158 Participants
|
102 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=10 Participants
|
38 Participants
n=8 Participants
|
45 Participants
n=18 Participants
|
42 Participants
n=158 Participants
|
168 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=10 Participants
|
3 Participants
n=8 Participants
|
8 Participants
n=18 Participants
|
3 Participants
n=158 Participants
|
15 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=10 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=18 Participants
|
3 Participants
n=158 Participants
|
6 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=10 Participants
|
27 Participants
n=8 Participants
|
32 Participants
n=18 Participants
|
29 Participants
n=158 Participants
|
111 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=10 Participants
|
46 Participants
n=8 Participants
|
42 Participants
n=18 Participants
|
49 Participants
n=158 Participants
|
181 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=3 Participants
|
|
Word Reading Fluency-2 (Zumeta et al., 2012)
|
2.41 Words read correctly
STANDARD_DEVIATION 2.55 • n=10 Participants
|
2.27 Words read correctly
STANDARD_DEVIATION 2.49 • n=8 Participants
|
2.47 Words read correctly
STANDARD_DEVIATION 2.48 • n=18 Participants
|
2.02 Words read correctly
STANDARD_DEVIATION 2.13 • n=158 Participants
|
2.29 Words read correctly
STANDARD_DEVIATION 2.40 • n=3 Participants
|
|
Sight Word Efficiency (TOWRE2; Wagner et al., 2012)
|
5.79 Words read correctly
STANDARD_DEVIATION 4.73 • n=10 Participants
|
5.81 Words read correctly
STANDARD_DEVIATION 5.55 • n=8 Participants
|
6.20 Words read correctly
STANDARD_DEVIATION 5.09 • n=18 Participants
|
5.81 Words read correctly
STANDARD_DEVIATION 4.46 • n=158 Participants
|
5.90 Words read correctly
STANDARD_DEVIATION 4.95 • n=3 Participants
|
|
Woodcock-Johnson IV - Letter Word Identification (Woodcock-Johnson 2014)
|
14.72 Number of correct responses
STANDARD_DEVIATION 4.74 • n=10 Participants
|
14.89 Number of correct responses
STANDARD_DEVIATION 4.51 • n=8 Participants
|
14.96 Number of correct responses
STANDARD_DEVIATION 5.17 • n=18 Participants
|
14.72 Number of correct responses
STANDARD_DEVIATION 4.05 • n=158 Participants
|
14.82 Number of correct responses
STANDARD_DEVIATION 4.60 • n=3 Participants
|
|
Arithmetic Combinations Fluency (Fuchs et al., 2003)
|
2.52 Number of correct answers
STANDARD_DEVIATION 2.22 • n=10 Participants
|
2.15 Number of correct answers
STANDARD_DEVIATION 2.25 • n=8 Participants
|
2.49 Number of correct answers
STANDARD_DEVIATION 3.05 • n=18 Participants
|
2.282 Number of correct answers
STANDARD_DEVIATION 2.52 • n=158 Participants
|
2.36 Number of correct answers
STANDARD_DEVIATION 2.53 • n=3 Participants
|
|
Double-Digit Calculations Fluency (Fuchs et al., 2003)
|
1.03 Number of correct answers
STANDARD_DEVIATION 2.22 • n=10 Participants
|
.71 Number of correct answers
STANDARD_DEVIATION 1.589 • n=8 Participants
|
1.14 Number of correct answers
STANDARD_DEVIATION 2.34 • n=18 Participants
|
.55 Number of correct answers
STANDARD_DEVIATION 1.52 • n=158 Participants
|
.85 Number of correct answers
STANDARD_DEVIATION 1.94 • n=3 Participants
|
|
Woodcock-Johnson IV - Calculations (Woodcock-Johnson 2014)
|
6.73 Number of correct responses
STANDARD_DEVIATION 4.80 • n=10 Participants
|
6.53 Number of correct responses
STANDARD_DEVIATION 4.76 • n=8 Participants
|
6.59 Number of correct responses
STANDARD_DEVIATION 4.78 • n=18 Participants
|
6.18 Number of correct responses
STANDARD_DEVIATION 4.24 • n=158 Participants
|
6.50 Number of correct responses
STANDARD_DEVIATION 4.80 • n=3 Participants
|
PRIMARY outcome
Timeframe: an average of 25 weeksStudents have 1 min to read 60 words randomly sampled/presented in bands of 5 words from most frequent words; then from next-most frequent words; etc. Student's score is the number of words read correctly. Two forms are given, and student's final score is the average score on the two forms.
Outcome measures
| Measure |
Coordinated Reading and Math Intervention
n=67 Participants
Coordinated intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction addressing similar skills as those addressed in the reading intervention arm \& similar skills as the math intervention arm.
|
Math Intervention
n=74 Participants
Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge, counting strategies, and arithmetic skill.
|
Reading Intervention
n=73 Participants
Reading intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction designed to build skill on letter-sound associations, decoding, sight words, \& contextualized reading.
|
Business-as-usual Control
n=78 Participants
Participation in the school's typical reading and math classroom instruction and, if designated by the school, its supplemental program.
|
|---|---|---|---|---|
|
Word Reading Fluency-2 (Zumeta et al., 2012)
|
10.216 words read correctly
Standard Deviation 8.916
|
7.068 words read correctly
Standard Deviation 7.799
|
12.349 words read correctly
Standard Deviation 10.158
|
7.385 words read correctly
Standard Deviation 8.178
|
PRIMARY outcome
Timeframe: an average of 25 weeksStudents have 45 seconds to read a list of words beginning with very simple words followed by words of increasing difficulty. Student's score is the number of words read correctly.
Outcome measures
| Measure |
Coordinated Reading and Math Intervention
n=67 Participants
Coordinated intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction addressing similar skills as those addressed in the reading intervention arm \& similar skills as the math intervention arm.
|
Math Intervention
n=74 Participants
Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge, counting strategies, and arithmetic skill.
|
Reading Intervention
n=73 Participants
Reading intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction designed to build skill on letter-sound associations, decoding, sight words, \& contextualized reading.
|
Business-as-usual Control
n=78 Participants
Participation in the school's typical reading and math classroom instruction and, if designated by the school, its supplemental program.
|
|---|---|---|---|---|
|
Sight Word Efficiency (TOWRE2; Wagner et al., 2012)
|
17.567 Words read correctly per 45 seconds
Standard Deviation 11.289
|
14.405 Words read correctly per 45 seconds
Standard Deviation 10.403
|
19.630 Words read correctly per 45 seconds
Standard Deviation 11.402
|
14.718 Words read correctly per 45 seconds
Standard Deviation 10.588
|
PRIMARY outcome
Timeframe: an average of 25 weeksStudents read aloud letters followed by simple words followed by words of increasing difficulty. Test ends when after six incorrect responses. Student's score is the number of correct responses.
Outcome measures
| Measure |
Coordinated Reading and Math Intervention
n=67 Participants
Coordinated intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction addressing similar skills as those addressed in the reading intervention arm \& similar skills as the math intervention arm.
|
Math Intervention
n=74 Participants
Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge, counting strategies, and arithmetic skill.
|
Reading Intervention
n=73 Participants
Reading intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction designed to build skill on letter-sound associations, decoding, sight words, \& contextualized reading.
|
Business-as-usual Control
n=78 Participants
Participation in the school's typical reading and math classroom instruction and, if designated by the school, its supplemental program.
|
|---|---|---|---|---|
|
Woodcock-Johnson IV - Letter Word Identification (Woodcock-Johnson 2014).
|
24.284 letters and words read aloud correctly
Standard Deviation 8.026
|
21.459 letters and words read aloud correctly
Standard Deviation 9.036
|
26.616 letters and words read aloud correctly
Standard Deviation 8.015
|
21.756 letters and words read aloud correctly
Standard Deviation 7.294
|
PRIMARY outcome
Timeframe: an average of 25 weeksStudents have 1 minute to write answers for 25 addition items; same for 25 subtraction items (sums \& minuends 5-12). Student's score is number correct across all 50 items.
Outcome measures
| Measure |
Coordinated Reading and Math Intervention
n=67 Participants
Coordinated intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction addressing similar skills as those addressed in the reading intervention arm \& similar skills as the math intervention arm.
|
Math Intervention
n=74 Participants
Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge, counting strategies, and arithmetic skill.
|
Reading Intervention
n=73 Participants
Reading intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction designed to build skill on letter-sound associations, decoding, sight words, \& contextualized reading.
|
Business-as-usual Control
n=78 Participants
Participation in the school's typical reading and math classroom instruction and, if designated by the school, its supplemental program.
|
|---|---|---|---|---|
|
Arithmetic Combinations Fluency (Fuchs et al., 2003)
|
11.269 the number of problems correct
Standard Deviation 8.233
|
15.014 the number of problems correct
Standard Deviation 10.550
|
6.849 the number of problems correct
Standard Deviation 6.628
|
6.269 the number of problems correct
Standard Deviation 5.986
|
PRIMARY outcome
Timeframe: an average of 25 weeksStudents have 10 min to write answers to 20 addition problems with 2-digit addends without regrouping and 20 subtraction problems with double-digit minuends and subtrahends without regrouping. The score is number correct across all 40 items.
Outcome measures
| Measure |
Coordinated Reading and Math Intervention
n=67 Participants
Coordinated intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction addressing similar skills as those addressed in the reading intervention arm \& similar skills as the math intervention arm.
|
Math Intervention
n=74 Participants
Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge, counting strategies, and arithmetic skill.
|
Reading Intervention
n=73 Participants
Reading intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction designed to build skill on letter-sound associations, decoding, sight words, \& contextualized reading.
|
Business-as-usual Control
n=78 Participants
Participation in the school's typical reading and math classroom instruction and, if designated by the school, its supplemental program.
|
|---|---|---|---|---|
|
Double-Digit Calculations Fluency (Fuchs et al., 2003)
|
6.284 number of problems correct
Standard Deviation 6.433
|
8.649 number of problems correct
Standard Deviation 7.925
|
0.740 number of problems correct
Standard Deviation 2.517
|
1.038 number of problems correct
Standard Deviation 3.077
|
PRIMARY outcome
Timeframe: an average of 25 weeksStudents solve mathematical computation problems beginning with simple basic facts followed by problems of increasing difficulty. Test ends when the student misses 6 consecutive problems. Student's score is the number of correct responses.
Outcome measures
| Measure |
Coordinated Reading and Math Intervention
n=67 Participants
Coordinated intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction addressing similar skills as those addressed in the reading intervention arm \& similar skills as the math intervention arm.
|
Math Intervention
n=74 Participants
Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge, counting strategies, and arithmetic skill.
|
Reading Intervention
n=73 Participants
Reading intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction designed to build skill on letter-sound associations, decoding, sight words, \& contextualized reading.
|
Business-as-usual Control
n=78 Participants
Participation in the school's typical reading and math classroom instruction and, if designated by the school, its supplemental program.
|
|---|---|---|---|---|
|
Woodcock-Johnson IV - Calculations (Woodcock-Johnson 2014)
|
13.090 The number of problems correct
Standard Deviation 4.754
|
13.811 The number of problems correct
Standard Deviation 4.550
|
10.795 The number of problems correct
Standard Deviation 4.595
|
9.679 The number of problems correct
Standard Deviation 4.697
|
Adverse Events
Coordinated Reading and Math Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Reading Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Math Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Business-as-usual 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place