Trial Outcomes & Findings for Literacy Promotion Using Automated Hovering (NCT NCT04576481)
NCT ID: NCT04576481
Last Updated: 2024-11-15
Results Overview
To determine acceptability, participants will be assessed on their overall satisfaction (5-point Likert scale 1=strong disagree, 2=disagree, 3=not sure, 4=agree and 5= strongly agree) with the study delivery intervention and answered survey questions regarding likes and dislikes concerning the intervention group they received following the intervention period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
2 months
Results posted on
2024-11-15
Participant Flow
Study participants in phase 1were parents only and were enrolled between November 17, 2020-June 30,2022 at the two participating practices. Study participants in phase 2 were parent-child dyads and were enrolled from July 20, 2021-October 28, 2021 at the two participating practices.
10 mothers of eligible children were enrolled in phase 1 and completed brief rapid cycle interviews. Demographic characteristics of these 10 participants were not collected.
Participant milestones
| Measure |
Phase 1
consists of rapid cycle interviews
|
Phase 2 Texting Arm: Text Messaging Only
Consist of daily text messages on shared reading
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
|
Phase 2 Regret Arm: Text Messaging + Coaching
Will consist of Group 1 plus personalized coaching.
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
Coaching: Personalized coaching content will be made available to participants through links in the text messages and will provide comparisons of their reading frequency with that of other participants.
|
Phase 2 Lottery Arm: Text Messaging + Coaching + Lottery
Will consist of Group 2 plus availability of a weekly lottery.
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
Coaching: Personalized coaching content will be made available to participants through links in the text messages and will provide comparisons of their reading frequency with that of other participants.
Lottery: Participants who reply to a text message that they read on a particular day will be entered into daily and weekly drawings to receive cash payments.
|
|---|---|---|---|---|
|
Rapid Cycle Interviews (Phase 1)
STARTED
|
10
|
0
|
0
|
0
|
|
Rapid Cycle Interviews (Phase 1)
COMPLETED
|
10
|
0
|
0
|
0
|
|
Rapid Cycle Interviews (Phase 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Randomized Controlled Trial (Phase 2)
STARTED
|
0
|
15
|
15
|
15
|
|
Randomized Controlled Trial (Phase 2)
Baseline Visit
|
0
|
15
|
15
|
15
|
|
Randomized Controlled Trial (Phase 2)
COMPLETED
|
0
|
14
|
12
|
14
|
|
Randomized Controlled Trial (Phase 2)
NOT COMPLETED
|
0
|
1
|
3
|
1
|
Reasons for withdrawal
| Measure |
Phase 1
consists of rapid cycle interviews
|
Phase 2 Texting Arm: Text Messaging Only
Consist of daily text messages on shared reading
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
|
Phase 2 Regret Arm: Text Messaging + Coaching
Will consist of Group 1 plus personalized coaching.
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
Coaching: Personalized coaching content will be made available to participants through links in the text messages and will provide comparisons of their reading frequency with that of other participants.
|
Phase 2 Lottery Arm: Text Messaging + Coaching + Lottery
Will consist of Group 2 plus availability of a weekly lottery.
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
Coaching: Personalized coaching content will be made available to participants through links in the text messages and will provide comparisons of their reading frequency with that of other participants.
Lottery: Participants who reply to a text message that they read on a particular day will be entered into daily and weekly drawings to receive cash payments.
|
|---|---|---|---|---|
|
Randomized Controlled Trial (Phase 2)
Lost to Follow-up
|
0
|
1
|
3
|
1
|
Baseline Characteristics
Age of child at enrollment (months), mean and SD provided.
Baseline characteristics by cohort
| Measure |
Phase 2 Texting Arm: Text Messaging
n=15 Participants
Consist of daily text messages on shared reading
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
|
Phase 2 Regret Arm: Text Messaging + Coaching
n=15 Participants
Will consist of Group 1 plus personalized coaching.
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
Coaching: Personalized coaching content will be made available to participants through links in the text messages and will provide comparisons of their reading frequency with that of other participants.
|
Phase 2 Lottery Arm: Text Messaging + Coaching + Lottery
n=15 Participants
Will consist of Group 2 plus availability of a weekly lottery.
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
Coaching: Personalized coaching content will be made available to participants through links in the text messages and will provide comparisons of their reading frequency with that of other participants.
Lottery: Participants who reply to a text message that they read on a particular day will be entered into daily and weekly drawings to receive cash payments.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
29.5 Years
STANDARD_DEVIATION 6.7 • n=15 Participants
|
24.8 Years
STANDARD_DEVIATION 4.9 • n=15 Participants
|
28.2 Years
STANDARD_DEVIATION 3.9 • n=15 Participants
|
27.6 Years
STANDARD_DEVIATION 5.6 • n=45 Participants
|
|
Sex: Female, Male
Sex of child enrolled · Female
|
8 Participants
n=15 Participants • Sex of all participants enrolled in phase 2.
|
8 Participants
n=15 Participants • Sex of all participants enrolled in phase 2.
|
4 Participants
n=15 Participants • Sex of all participants enrolled in phase 2.
|
20 Participants
n=45 Participants • Sex of all participants enrolled in phase 2.
|
|
Sex: Female, Male
Sex of child enrolled · Male
|
7 Participants
n=15 Participants • Sex of all participants enrolled in phase 2.
|
7 Participants
n=15 Participants • Sex of all participants enrolled in phase 2.
|
11 Participants
n=15 Participants • Sex of all participants enrolled in phase 2.
|
25 Participants
n=45 Participants • Sex of all participants enrolled in phase 2.
|
|
Sex: Female, Male
Sex of caregiver enrolled · Female
|
14 Participants
n=15 Participants • Sex of all participants enrolled in phase 2.
|
13 Participants
n=15 Participants • Sex of all participants enrolled in phase 2.
|
15 Participants
n=15 Participants • Sex of all participants enrolled in phase 2.
|
42 Participants
n=45 Participants • Sex of all participants enrolled in phase 2.
|
|
Sex: Female, Male
Sex of caregiver enrolled · Male
|
1 Participants
n=15 Participants • Sex of all participants enrolled in phase 2.
|
2 Participants
n=15 Participants • Sex of all participants enrolled in phase 2.
|
0 Participants
n=15 Participants • Sex of all participants enrolled in phase 2.
|
3 Participants
n=45 Participants • Sex of all participants enrolled in phase 2.
|
|
Ethnicity (NIH/OMB)
Ethnicity of Children Enrolled · Hispanic or Latino
|
1 Participants
n=15 Participants • Characteristic of Ethnicity (n=43) for both child and caregiver enrolled in phase 2. A total of two participants did not complete measure.
|
0 Participants
n=13 Participants • Characteristic of Ethnicity (n=43) for both child and caregiver enrolled in phase 2. A total of two participants did not complete measure.
|
1 Participants
n=15 Participants • Characteristic of Ethnicity (n=43) for both child and caregiver enrolled in phase 2. A total of two participants did not complete measure.
|
2 Participants
n=43 Participants • Characteristic of Ethnicity (n=43) for both child and caregiver enrolled in phase 2. A total of two participants did not complete measure.
|
|
Ethnicity (NIH/OMB)
Ethnicity of Children Enrolled · Not Hispanic or Latino
|
14 Participants
n=15 Participants • Characteristic of Ethnicity (n=43) for both child and caregiver enrolled in phase 2. A total of two participants did not complete measure.
|
13 Participants
n=13 Participants • Characteristic of Ethnicity (n=43) for both child and caregiver enrolled in phase 2. A total of two participants did not complete measure.
|
14 Participants
n=15 Participants • Characteristic of Ethnicity (n=43) for both child and caregiver enrolled in phase 2. A total of two participants did not complete measure.
|
41 Participants
n=43 Participants • Characteristic of Ethnicity (n=43) for both child and caregiver enrolled in phase 2. A total of two participants did not complete measure.
|
|
Ethnicity (NIH/OMB)
Ethnicity of Children Enrolled · Unknown or Not Reported
|
0 Participants
n=15 Participants • Characteristic of Ethnicity (n=43) for both child and caregiver enrolled in phase 2. A total of two participants did not complete measure.
|
0 Participants
n=13 Participants • Characteristic of Ethnicity (n=43) for both child and caregiver enrolled in phase 2. A total of two participants did not complete measure.
|
0 Participants
n=15 Participants • Characteristic of Ethnicity (n=43) for both child and caregiver enrolled in phase 2. A total of two participants did not complete measure.
|
0 Participants
n=43 Participants • Characteristic of Ethnicity (n=43) for both child and caregiver enrolled in phase 2. A total of two participants did not complete measure.
|
|
Ethnicity (NIH/OMB)
Ethnicity of Caregiver Enrolled · Hispanic or Latino
|
1 Participants
n=15 Participants • Characteristic of Ethnicity (n=43) for both child and caregiver enrolled in phase 2. A total of two participants did not complete measure.
|
0 Participants
n=13 Participants • Characteristic of Ethnicity (n=43) for both child and caregiver enrolled in phase 2. A total of two participants did not complete measure.
|
1 Participants
n=15 Participants • Characteristic of Ethnicity (n=43) for both child and caregiver enrolled in phase 2. A total of two participants did not complete measure.
|
2 Participants
n=43 Participants • Characteristic of Ethnicity (n=43) for both child and caregiver enrolled in phase 2. A total of two participants did not complete measure.
|
|
Ethnicity (NIH/OMB)
Ethnicity of Caregiver Enrolled · Not Hispanic or Latino
|
14 Participants
n=15 Participants • Characteristic of Ethnicity (n=43) for both child and caregiver enrolled in phase 2. A total of two participants did not complete measure.
|
13 Participants
n=13 Participants • Characteristic of Ethnicity (n=43) for both child and caregiver enrolled in phase 2. A total of two participants did not complete measure.
|
14 Participants
n=15 Participants • Characteristic of Ethnicity (n=43) for both child and caregiver enrolled in phase 2. A total of two participants did not complete measure.
|
41 Participants
n=43 Participants • Characteristic of Ethnicity (n=43) for both child and caregiver enrolled in phase 2. A total of two participants did not complete measure.
|
|
Ethnicity (NIH/OMB)
Ethnicity of Caregiver Enrolled · Unknown or Not Reported
|
0 Participants
n=15 Participants • Characteristic of Ethnicity (n=43) for both child and caregiver enrolled in phase 2. A total of two participants did not complete measure.
|
0 Participants
n=13 Participants • Characteristic of Ethnicity (n=43) for both child and caregiver enrolled in phase 2. A total of two participants did not complete measure.
|
0 Participants
n=15 Participants • Characteristic of Ethnicity (n=43) for both child and caregiver enrolled in phase 2. A total of two participants did not complete measure.
|
0 Participants
n=43 Participants • Characteristic of Ethnicity (n=43) for both child and caregiver enrolled in phase 2. A total of two participants did not complete measure.
|
|
Race (NIH/OMB)
Child · American Indian or Alaska Native
|
0 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=13 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=43 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
|
Race (NIH/OMB)
Child · Asian
|
0 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=13 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=43 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
|
Race (NIH/OMB)
Child · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=13 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=43 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
|
Race (NIH/OMB)
Child · Black or African American
|
14 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
8 Participants
n=13 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
13 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
35 Participants
n=43 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
|
Race (NIH/OMB)
Child · White
|
1 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=13 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
2 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
3 Participants
n=43 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
|
Race (NIH/OMB)
Child · More than one race
|
0 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
5 Participants
n=13 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
5 Participants
n=43 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
|
Race (NIH/OMB)
Child · Unknown or Not Reported
|
0 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=13 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=43 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
|
Race (NIH/OMB)
Caregiver · American Indian or Alaska Native
|
0 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=13 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=43 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
|
Race (NIH/OMB)
Caregiver · Asian
|
0 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=13 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=43 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
|
Race (NIH/OMB)
Caregiver · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=13 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=43 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
|
Race (NIH/OMB)
Caregiver · Black or African American
|
13 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
8 Participants
n=13 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
14 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
35 Participants
n=43 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
|
Race (NIH/OMB)
Caregiver · White
|
1 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=13 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
1 Participants
n=43 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
|
Race (NIH/OMB)
Caregiver · More than one race
|
1 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
5 Participants
n=13 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
1 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
7 Participants
n=43 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
|
Race (NIH/OMB)
Caregiver · Unknown or Not Reported
|
0 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=13 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=15 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
0 Participants
n=43 Participants • Race of child and caregiver enrolled in phase 2 of study. A total of two participants did not complete measure.
|
|
Recruitment Site
Cobbs Creek
|
3 Participants
n=15 Participants
|
2 Participants
n=15 Participants
|
1 Participants
n=15 Participants
|
6 Participants
n=45 Participants
|
|
Recruitment Site
Karabots
|
12 Participants
n=15 Participants
|
13 Participants
n=15 Participants
|
14 Participants
n=15 Participants
|
39 Participants
n=45 Participants
|
|
Children per caregiver
|
2.3 avg. number children per caregiver
STANDARD_DEVIATION 1.8 • n=15 Participants • A total of two participants did not complete measure.
|
1.8 avg. number children per caregiver
STANDARD_DEVIATION 1.2 • n=13 Participants • A total of two participants did not complete measure.
|
2.2 avg. number children per caregiver
STANDARD_DEVIATION 1.1 • n=15 Participants • A total of two participants did not complete measure.
|
2.1 avg. number children per caregiver
STANDARD_DEVIATION 1.4 • n=43 Participants • A total of two participants did not complete measure.
|
|
Marital Status
Married/Living together
|
6 Participants
n=15 Participants • Marital status of caregivers enrolled in phase 2. A total of two participants (both in regret arm) did not complete measure.
|
5 Participants
n=13 Participants • Marital status of caregivers enrolled in phase 2. A total of two participants (both in regret arm) did not complete measure.
|
4 Participants
n=15 Participants • Marital status of caregivers enrolled in phase 2. A total of two participants (both in regret arm) did not complete measure.
|
15 Participants
n=43 Participants • Marital status of caregivers enrolled in phase 2. A total of two participants (both in regret arm) did not complete measure.
|
|
Marital Status
Single, never married
|
9 Participants
n=15 Participants • Marital status of caregivers enrolled in phase 2. A total of two participants (both in regret arm) did not complete measure.
|
8 Participants
n=13 Participants • Marital status of caregivers enrolled in phase 2. A total of two participants (both in regret arm) did not complete measure.
|
11 Participants
n=15 Participants • Marital status of caregivers enrolled in phase 2. A total of two participants (both in regret arm) did not complete measure.
|
28 Participants
n=43 Participants • Marital status of caregivers enrolled in phase 2. A total of two participants (both in regret arm) did not complete measure.
|
|
Education
Grades 9-11
|
0 Participants
n=15 Participants • Education level of caregivers enrolled in phase 2. A total of two participant (both in regret arm) did not complete measure.
|
2 Participants
n=13 Participants • Education level of caregivers enrolled in phase 2. A total of two participant (both in regret arm) did not complete measure.
|
1 Participants
n=15 Participants • Education level of caregivers enrolled in phase 2. A total of two participant (both in regret arm) did not complete measure.
|
3 Participants
n=43 Participants • Education level of caregivers enrolled in phase 2. A total of two participant (both in regret arm) did not complete measure.
|
|
Education
High School/GED
|
6 Participants
n=15 Participants • Education level of caregivers enrolled in phase 2. A total of two participant (both in regret arm) did not complete measure.
|
5 Participants
n=13 Participants • Education level of caregivers enrolled in phase 2. A total of two participant (both in regret arm) did not complete measure.
|
10 Participants
n=15 Participants • Education level of caregivers enrolled in phase 2. A total of two participant (both in regret arm) did not complete measure.
|
21 Participants
n=43 Participants • Education level of caregivers enrolled in phase 2. A total of two participant (both in regret arm) did not complete measure.
|
|
Education
Some college/ college graduate
|
9 Participants
n=15 Participants • Education level of caregivers enrolled in phase 2. A total of two participant (both in regret arm) did not complete measure.
|
5 Participants
n=13 Participants • Education level of caregivers enrolled in phase 2. A total of two participant (both in regret arm) did not complete measure.
|
3 Participants
n=15 Participants • Education level of caregivers enrolled in phase 2. A total of two participant (both in regret arm) did not complete measure.
|
17 Participants
n=43 Participants • Education level of caregivers enrolled in phase 2. A total of two participant (both in regret arm) did not complete measure.
|
|
Education
Post-college
|
0 Participants
n=15 Participants • Education level of caregivers enrolled in phase 2. A total of two participant (both in regret arm) did not complete measure.
|
1 Participants
n=13 Participants • Education level of caregivers enrolled in phase 2. A total of two participant (both in regret arm) did not complete measure.
|
1 Participants
n=15 Participants • Education level of caregivers enrolled in phase 2. A total of two participant (both in regret arm) did not complete measure.
|
2 Participants
n=43 Participants • Education level of caregivers enrolled in phase 2. A total of two participant (both in regret arm) did not complete measure.
|
|
Income
<$25,000
|
4 Participants
n=13 Participants • Income of caregivers enrolled in phase (n=37) 2. A total of 2 participants did not complete the measure and a total of 6 participants missing (chose not to answer).
|
7 Participants
n=12 Participants • Income of caregivers enrolled in phase (n=37) 2. A total of 2 participants did not complete the measure and a total of 6 participants missing (chose not to answer).
|
8 Participants
n=12 Participants • Income of caregivers enrolled in phase (n=37) 2. A total of 2 participants did not complete the measure and a total of 6 participants missing (chose not to answer).
|
19 Participants
n=37 Participants • Income of caregivers enrolled in phase (n=37) 2. A total of 2 participants did not complete the measure and a total of 6 participants missing (chose not to answer).
|
|
Income
$25,000 - $54,999
|
7 Participants
n=13 Participants • Income of caregivers enrolled in phase (n=37) 2. A total of 2 participants did not complete the measure and a total of 6 participants missing (chose not to answer).
|
3 Participants
n=12 Participants • Income of caregivers enrolled in phase (n=37) 2. A total of 2 participants did not complete the measure and a total of 6 participants missing (chose not to answer).
|
3 Participants
n=12 Participants • Income of caregivers enrolled in phase (n=37) 2. A total of 2 participants did not complete the measure and a total of 6 participants missing (chose not to answer).
|
13 Participants
n=37 Participants • Income of caregivers enrolled in phase (n=37) 2. A total of 2 participants did not complete the measure and a total of 6 participants missing (chose not to answer).
|
|
Income
>$55,000
|
2 Participants
n=13 Participants • Income of caregivers enrolled in phase (n=37) 2. A total of 2 participants did not complete the measure and a total of 6 participants missing (chose not to answer).
|
2 Participants
n=12 Participants • Income of caregivers enrolled in phase (n=37) 2. A total of 2 participants did not complete the measure and a total of 6 participants missing (chose not to answer).
|
1 Participants
n=12 Participants • Income of caregivers enrolled in phase (n=37) 2. A total of 2 participants did not complete the measure and a total of 6 participants missing (chose not to answer).
|
5 Participants
n=37 Participants • Income of caregivers enrolled in phase (n=37) 2. A total of 2 participants did not complete the measure and a total of 6 participants missing (chose not to answer).
|
|
Measure of Cognitive Stimulation Provided in the Home (Reading Subscale)
|
12.9 units on a scale
STANDARD_DEVIATION 3.2 • n=14 Participants • A total of 3 participants did not complete the StimQ-read measure at baseline.
|
12.8 units on a scale
STANDARD_DEVIATION 4.5 • n=14 Participants • A total of 3 participants did not complete the StimQ-read measure at baseline.
|
15 units on a scale
STANDARD_DEVIATION 3.6 • n=14 Participants • A total of 3 participants did not complete the StimQ-read measure at baseline.
|
13.6 units on a scale
STANDARD_DEVIATION 3.8 • n=42 Participants • A total of 3 participants did not complete the StimQ-read measure at baseline.
|
|
Parenting Stress Index-Short Form (PSI-SF)
|
56.3 units on a scale
STANDARD_DEVIATION 18.6 • n=14 Participants • A total of 3 participants did not complete the PSI-SF measure at baseline.
|
62.6 units on a scale
STANDARD_DEVIATION 22.5 • n=14 Participants • A total of 3 participants did not complete the PSI-SF measure at baseline.
|
53.6 units on a scale
STANDARD_DEVIATION 13.3 • n=14 Participants • A total of 3 participants did not complete the PSI-SF measure at baseline.
|
57.5 units on a scale
STANDARD_DEVIATION 18.5 • n=42 Participants • A total of 3 participants did not complete the PSI-SF measure at baseline.
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: A total of 42 participant completed the measure. 3 participants were lost to follow-up
To determine acceptability, participants will be assessed on their overall satisfaction (5-point Likert scale 1=strong disagree, 2=disagree, 3=not sure, 4=agree and 5= strongly agree) with the study delivery intervention and answered survey questions regarding likes and dislikes concerning the intervention group they received following the intervention period.
Outcome measures
| Measure |
Phase 2 Texting Arm: Text Messaging
n=14 Participants
Consist of daily text messages on shared reading
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
|
Phase 2 Regret Arm: Text Messaging + Coaching
n=13 Participants
Will consist of Group 1 plus personalized coaching.
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
Coaching: Personalized coaching content will be made available to participants through links in the text messages and will provide comparisons of their reading frequency with that of other participants.
|
Phase 2 Lottery Arm: Text Messaging + Coaching + Lottery
n=15 Participants
Will consist of Group 2 plus availability of a weekly lottery.
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
Coaching: Personalized coaching content will be made available to participants through links in the text messages and will provide comparisons of their reading frequency with that of other participants.
Lottery: Participants who reply to a text message that they read on a particular day will be entered into daily and weekly drawings to receive cash payments.
|
Phase 1
consists of rapid cycle interviews
|
|---|---|---|---|---|
|
Acceptability Survey
|
4 score on a scale
Standard Deviation 1.1
|
3.3 score on a scale
Standard Deviation 1.3
|
3.8 score on a scale
Standard Deviation 1.2
|
—
|
PRIMARY outcome
Timeframe: 2 monthsPercentage of study participants who completed the 2-month follow-up
Outcome measures
| Measure |
Phase 2 Texting Arm: Text Messaging
n=15 Participants
Consist of daily text messages on shared reading
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
|
Phase 2 Regret Arm: Text Messaging + Coaching
n=15 Participants
Will consist of Group 1 plus personalized coaching.
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
Coaching: Personalized coaching content will be made available to participants through links in the text messages and will provide comparisons of their reading frequency with that of other participants.
|
Phase 2 Lottery Arm: Text Messaging + Coaching + Lottery
n=15 Participants
Will consist of Group 2 plus availability of a weekly lottery.
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
Coaching: Personalized coaching content will be made available to participants through links in the text messages and will provide comparisons of their reading frequency with that of other participants.
Lottery: Participants who reply to a text message that they read on a particular day will be entered into daily and weekly drawings to receive cash payments.
|
Phase 1
n=10 Participants
consists of rapid cycle interviews
|
|---|---|---|---|---|
|
Feasibility of Study
|
14 Participants
|
13 Participants
|
15 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 2 monthsTo determine change in home reading environment, Investigators will examine differences in the Read subscale of the measure of Cognitive Stimulation provided in the home (StimQ) from baseline to 2 months. The Read subscale of the StimQ is a validated 14-item parent self-report questionnaire designed to measure of the home reading environment for children ages 5 to 72 months of age with a maximum score of 18 and a minimum score of 0. The higher score indicates a better home reading environment. The change in score from baseline to follow-up (2-months) will be used.
Outcome measures
| Measure |
Phase 2 Texting Arm: Text Messaging
n=13 Participants
Consist of daily text messages on shared reading
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
|
Phase 2 Regret Arm: Text Messaging + Coaching
n=13 Participants
Will consist of Group 1 plus personalized coaching.
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
Coaching: Personalized coaching content will be made available to participants through links in the text messages and will provide comparisons of their reading frequency with that of other participants.
|
Phase 2 Lottery Arm: Text Messaging + Coaching + Lottery
n=14 Participants
Will consist of Group 2 plus availability of a weekly lottery.
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
Coaching: Personalized coaching content will be made available to participants through links in the text messages and will provide comparisons of their reading frequency with that of other participants.
Lottery: Participants who reply to a text message that they read on a particular day will be entered into daily and weekly drawings to receive cash payments.
|
Phase 1
consists of rapid cycle interviews
|
|---|---|---|---|---|
|
Change in Score of Cognitive Stimulation Provided in the Home Measure - (StimQ-Read)
|
1.8 score on a scale
Standard Deviation 2.8
|
3.2 score on a scale
Standard Deviation 4.0
|
1.3 score on a scale
Standard Deviation 2.7
|
—
|
SECONDARY outcome
Timeframe: 2 monthsTo determine change in parenting stress, Investigators will examine differences in the Parenting Stress Index- Short Form (PSI-SF) from baseline to follow-up (2 months). The PSI-SF is a validated 36-item scale that measures parenting stress, and it has been shown to have excellent internal consistency and to be positively associated with maternal psychological distress. The scores can range from 36 to 180 with an higher scores overall indicating higher levels of parenting stress. The change in score from baseline to follow-up (2-months) will be used.
Outcome measures
| Measure |
Phase 2 Texting Arm: Text Messaging
n=13 Participants
Consist of daily text messages on shared reading
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
|
Phase 2 Regret Arm: Text Messaging + Coaching
n=13 Participants
Will consist of Group 1 plus personalized coaching.
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
Coaching: Personalized coaching content will be made available to participants through links in the text messages and will provide comparisons of their reading frequency with that of other participants.
|
Phase 2 Lottery Arm: Text Messaging + Coaching + Lottery
n=14 Participants
Will consist of Group 2 plus availability of a weekly lottery.
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
Coaching: Personalized coaching content will be made available to participants through links in the text messages and will provide comparisons of their reading frequency with that of other participants.
Lottery: Participants who reply to a text message that they read on a particular day will be entered into daily and weekly drawings to receive cash payments.
|
Phase 1
consists of rapid cycle interviews
|
|---|---|---|---|---|
|
Change in Score for The Parenting Stress Index - Short Form (PSI-SF)
|
2.2 score on a scale
Standard Deviation 18.2
|
5.3 score on a scale
Standard Deviation 16.4
|
9 score on a scale
Standard Deviation 34.5
|
—
|
SECONDARY outcome
Timeframe: 2 monthsInvestigators will measure reading frequency as the average number of days per week of reported parent-child shared reading. This is a measure of parent's self-reported reading frequency using question 2 from Cognitive Stimulation Provided in the Home Measure Reading Subscales, Parents are asked "How many days each week do you read children's books to your child?". Scores will be collected at baseline and at the 2-month follow-up. Change in reading frequency will be computed by subtracting the days reading at baseline from the days reading at follow-up.
Outcome measures
| Measure |
Phase 2 Texting Arm: Text Messaging
n=14 Participants
Consist of daily text messages on shared reading
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
|
Phase 2 Regret Arm: Text Messaging + Coaching
n=13 Participants
Will consist of Group 1 plus personalized coaching.
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
Coaching: Personalized coaching content will be made available to participants through links in the text messages and will provide comparisons of their reading frequency with that of other participants.
|
Phase 2 Lottery Arm: Text Messaging + Coaching + Lottery
n=15 Participants
Will consist of Group 2 plus availability of a weekly lottery.
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
Coaching: Personalized coaching content will be made available to participants through links in the text messages and will provide comparisons of their reading frequency with that of other participants.
Lottery: Participants who reply to a text message that they read on a particular day will be entered into daily and weekly drawings to receive cash payments.
|
Phase 1
consists of rapid cycle interviews
|
|---|---|---|---|---|
|
Change in Weekly Parent-Child Shared Reading Frequency
Days per week reading at baseline
|
4.1 days per week reading
Standard Deviation 1.8
|
4.0 days per week reading
Standard Deviation 1.8
|
4.8 days per week reading
Standard Deviation 1.5
|
—
|
|
Change in Weekly Parent-Child Shared Reading Frequency
Days per week reading at 2-month follow-up
|
3.9 days per week reading
Standard Deviation 2.0
|
4.2 days per week reading
Standard Deviation 1.7
|
4.9 days per week reading
Standard Deviation 1.5
|
—
|
|
Change in Weekly Parent-Child Shared Reading Frequency
Change in reading frequency (days per week
|
-0.3 days per week reading
Standard Deviation 2.2
|
0.2 days per week reading
Standard Deviation 2.6
|
0.1 days per week reading
Standard Deviation 1.7
|
—
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: A total of 7 participants did not complete DECA. 3 participants were lost to follow-up and 4 participant scores were dropped (\>18 mo at time of measure completion).
Investigators will measure child socio-emotional development at 2 months using the Devereax Early Childhood Assessment (DECA), a validated 33-item parent report of social emotional problems for children 9-36 months of age. All 33 items are used to calculate the raw total protective factor (TPF). 18/33 items are used to calculate raw Initiative sub scale (infant's ability to use independent thought and action to meet his/her needs). 15/33 items are used to calculate raw Attachment/Relationships sub scale (mutual, strong, long-lasting relationship between the infant and significant adults such as family members, and teachers). Higher scores indicate greater social emotional development. For all 33 items parents can report (Never 0, Rarely 1, Occasionally 2, Frequently 3, Very Frequently 4). Raw total scores can range from 0-132, with higher scores indicating a better outcome.
Outcome measures
| Measure |
Phase 2 Texting Arm: Text Messaging
n=13 Participants
Consist of daily text messages on shared reading
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
|
Phase 2 Regret Arm: Text Messaging + Coaching
n=12 Participants
Will consist of Group 1 plus personalized coaching.
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
Coaching: Personalized coaching content will be made available to participants through links in the text messages and will provide comparisons of their reading frequency with that of other participants.
|
Phase 2 Lottery Arm: Text Messaging + Coaching + Lottery
n=13 Participants
Will consist of Group 2 plus availability of a weekly lottery.
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
Coaching: Personalized coaching content will be made available to participants through links in the text messages and will provide comparisons of their reading frequency with that of other participants.
Lottery: Participants who reply to a text message that they read on a particular day will be entered into daily and weekly drawings to receive cash payments.
|
Phase 1
consists of rapid cycle interviews
|
|---|---|---|---|---|
|
Measure of Child Socio-Emotional Development Using Devereux Early Childhood Assessment (DECA)
Initiative Score
|
77.6 score on a scale
Standard Deviation 18.7
|
64.3 score on a scale
Standard Deviation 27.3
|
72.1 score on a scale
Standard Deviation 28.6
|
—
|
|
Measure of Child Socio-Emotional Development Using Devereux Early Childhood Assessment (DECA)
Attachment/Relationship Score
|
79.4 score on a scale
Standard Deviation 19.4
|
66.6 score on a scale
Standard Deviation 31.2
|
75.6 score on a scale
Standard Deviation 27.8
|
—
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: A total of 7 participants were unable to be used in CDI calculations. 3 participants were lost to follow-up and an additional 4 participant scores were dropped due to aging out of measure's age range (\>18 mo at time survey was completed).
Investigators measured child language development at 2 months using the MacArthur Communicative Development Inventory (CDI), a validated parent report scale of early child language development for children 8-30 months of age. Parents are asked to indicate the words their child understands but does not yet say in the first column (understands). For words that their child understands, Parents are asked to indicate which words their child says in the second column (understand and says). The raw total scores are inputted into a norming table for the CDI where a production (understand and says) and comprehension (understands) scores are generated based on the child's age and gender. Total scores can range from (0-178) with higher scores on the norming chart correlating to a higher percentile in comprehension or production. Total score is calculated by using summed scores where: blank = 0, understands = 1 and understands and speaks=2. Total scores were converted to percentile scores.
Outcome measures
| Measure |
Phase 2 Texting Arm: Text Messaging
n=14 Participants
Consist of daily text messages on shared reading
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
|
Phase 2 Regret Arm: Text Messaging + Coaching
n=12 Participants
Will consist of Group 1 plus personalized coaching.
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
Coaching: Personalized coaching content will be made available to participants through links in the text messages and will provide comparisons of their reading frequency with that of other participants.
|
Phase 2 Lottery Arm: Text Messaging + Coaching + Lottery
n=13 Participants
Will consist of Group 2 plus availability of a weekly lottery.
Text Messaging: Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
Coaching: Personalized coaching content will be made available to participants through links in the text messages and will provide comparisons of their reading frequency with that of other participants.
Lottery: Participants who reply to a text message that they read on a particular day will be entered into daily and weekly drawings to receive cash payments.
|
Phase 1
consists of rapid cycle interviews
|
|---|---|---|---|---|
|
Measure of Child Language Development Using MacArthur Communicative Development Inventory (CDI) - Percentiles
|
84.6 Score Percentiles (%)
Standard Deviation 29.7
|
78.5 Score Percentiles (%)
Standard Deviation 33.2
|
63.1 Score Percentiles (%)
Standard Deviation 42.6
|
—
|
Adverse Events
Phase 1: Rapid Cycle Interviews
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2 Texting Arm: Text Messaging
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2 Regret Arm: Text Messaging + Coaching
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2 Lottery Arm: Text Messaging + Coaching + Lottery
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
James Guevara, MD MPH
Children's Hospital of Philadelphia
Phone: 215-590-1130
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place