Trial Outcomes & Findings for A Family Centered Intervention to Promote Optimal Child Development (NCT NCT01941186)
NCT ID: NCT01941186
Last Updated: 2016-10-21
Results Overview
Completed intake and evaluation by the early intervention (EI) agency was assessed by parent report and by chart review. A member of the study team contacted parents within 6 months of the first study visit to obtain this information. Additionally, a chart review seeking written feedback information regarding referral disposition from the EI agency was completed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
Up to 1 year after randomization
Results posted on
2016-10-21
Participant Flow
Participants were recruited from 2 urban pediatric practice sites within the Children's Hospital of Philadelphia Pediatric Research Consortium, a primary care-based network including 31 practices in 2 states, between December 2013 and September 2014.
164 parent-child dyads were assessed for eligibility and 100 were excluded. Reasons for exclusion were primarily because potential subjects either not meeting eligibility criteria (i.e., already received early intervention) or they declined to participate. 64 parent-child dyads were consented and randomized.
Participant milestones
| Measure |
Patient Decision Aid
After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.
Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services.
|
Routine Care
After screening positive for a potential development delay those in the control received routine care, in this case, a handout explaining Early Intervention services.
|
|---|---|---|
|
Randomization/Allocation to Study Group
STARTED
|
31
|
33
|
|
Randomization/Allocation to Study Group
COMPLETED
|
31
|
33
|
|
Randomization/Allocation to Study Group
NOT COMPLETED
|
0
|
0
|
|
Follow-up
STARTED
|
31
|
33
|
|
Follow-up
COMPLETED
|
30
|
33
|
|
Follow-up
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Patient Decision Aid
After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.
Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services.
|
Routine Care
After screening positive for a potential development delay those in the control received routine care, in this case, a handout explaining Early Intervention services.
|
|---|---|---|
|
Follow-up
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
A Family Centered Intervention to Promote Optimal Child Development
Baseline characteristics by cohort
| Measure |
Patient Decision Aid
n=31 Participants
After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.
Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services.
|
Routine Care
n=33 Participants
After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Child: Age 1-12 months
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Age, Customized
Child: Age 13-24 months
|
20 participants
n=5 Participants
|
22 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Age, Customized
Child: Age 25-36 months
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Age, Customized
Parent: 20 years and Under
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Age, Customized
Parent: 21-30 Years
|
15 participants
n=5 Participants
|
18 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Age, Customized
Parent: 31-40 Years
|
10 participants
n=5 Participants
|
6 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Age, Customized
Parent: Over 40 Years
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Age, Customized
Parent: Unknown Age
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
24 participants
n=5 Participants
|
32 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 participants
n=5 Participants
|
1 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
33 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Parent's Education
Less than High School
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Parent's Education
High School Graduate
|
23 participants
n=5 Participants
|
27 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Parent's Education
Post Secondary Education
|
7 participants
n=5 Participants
|
2 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Parent's Employment Status
Employed
|
17 participants
n=5 Participants
|
20 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Parent's Employment Status
Unemployed
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Parent's Marital Status
Married/Living with Partner
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Parent's Marital Status
Divorced/Separated
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Parent's Marital Status
Never Married
|
14 participants
n=5 Participants
|
18 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 year after randomizationPopulation: One parent-child dyad had missing information regarding EI intake and evaluation. Given the absence of information on referral outcome, this parent-child dyad was included in the final evaluation as having not received an EI intake and evaluation.
Completed intake and evaluation by the early intervention (EI) agency was assessed by parent report and by chart review. A member of the study team contacted parents within 6 months of the first study visit to obtain this information. Additionally, a chart review seeking written feedback information regarding referral disposition from the EI agency was completed.
Outcome measures
| Measure |
Patient Decision Aid
n=31 Participants
After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.
Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services.
|
Routine Care
n=33 Participants
After screening positive for a potential development delay those in the control received routine care, in this case, a handout explaining Early Intervention services.
|
Patient Decision Aid: Somewhat Disagree
Percentage of parents who answered "somewhat disagree" to questions during pre and post
|
Patient Decision Aid: Somewhat Agree
Percentage of parents who answered "somewhat agree" to questions during pre and post intervention
|
Patient Decision Aid: Agree
Percentage of parents who answered "agree" to questions during pre and post intervention
|
Patient Decision Aid: Strongly Agree
Percentage of parents who answered "Strongly Agree" to questions during pre and post intervention
|
Routine Care: Strongly Disagree
Percentage of parents who answered "strongly disagree" to questions during pre and post intervention
|
Routine Care: Disagree
Percentage of parents who answered "disagree" to questions during pre and post intervention
|
Routine Care: Somewhat Disagree
Percentage of parents who answered "somewhat disagree" to questions during pre and post intervention
|
Routine Care: Somewhat Agree
Percentage of parents who answered "somewhat agree" to questions during pre and post intervention.
|
Routine Care: Agree
Percentage of parents who answered "agree" to questions during pre and post intervention
|
Routine Care: Strongly Agree
Percentage of parents who answered "strongly agree" to questions during pre and post intervention
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Difference in the Number of Participants Who Completed Early Intervention Intake and Evaluation Visits Between Treatment Groups
Early Intervention Evaluation
|
17 participants
|
17 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference in the Number of Participants Who Completed Early Intervention Intake and Evaluation Visits Between Treatment Groups
Early Intervention Intake
|
20 participants
|
21 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 7 daysPopulation: All parent-child dyads who were enrolled and randomized were included in the analysis.
Pre and post knowledge and attitudes regarding developmental delay and early intervention (EI) were assessed by asking participants to respond to 14 statements using a 6 point Likert scale that ranged from strongly disagree to strongly agree. Questions mapped to the video decision aid content viewed by participants. Participants in the intervention arm completed the questions before and after watching the video and participants in the control arm completed the questions sequentially. Secondary outcome measures assessed in the survey included Parent Uncertainty About Early Intervention and Parental Predisposition for Early Intervention.
Outcome measures
| Measure |
Patient Decision Aid
n=31 Participants
After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.
Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services.
|
Routine Care
n=31 Participants
After screening positive for a potential development delay those in the control received routine care, in this case, a handout explaining Early Intervention services.
|
Patient Decision Aid: Somewhat Disagree
n=31 Participants
Percentage of parents who answered "somewhat disagree" to questions during pre and post
|
Patient Decision Aid: Somewhat Agree
n=31 Participants
Percentage of parents who answered "somewhat agree" to questions during pre and post intervention
|
Patient Decision Aid: Agree
n=31 Participants
Percentage of parents who answered "agree" to questions during pre and post intervention
|
Patient Decision Aid: Strongly Agree
n=31 Participants
Percentage of parents who answered "Strongly Agree" to questions during pre and post intervention
|
Routine Care: Strongly Disagree
n=33 Participants
Percentage of parents who answered "strongly disagree" to questions during pre and post intervention
|
Routine Care: Disagree
n=33 Participants
Percentage of parents who answered "disagree" to questions during pre and post intervention
|
Routine Care: Somewhat Disagree
n=33 Participants
Percentage of parents who answered "somewhat disagree" to questions during pre and post intervention
|
Routine Care: Somewhat Agree
n=33 Participants
Percentage of parents who answered "somewhat agree" to questions during pre and post intervention.
|
Routine Care: Agree
n=33 Participants
Percentage of parents who answered "agree" to questions during pre and post intervention
|
Routine Care: Strongly Agree
n=33 Participants
Percentage of parents who answered "strongly agree" to questions during pre and post intervention
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
EI helps kids w/develop delay (pre)
|
6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16 percentage of participants
|
42 percentage of participants
|
35 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
9 percentage of participants
|
64 percentage of participants
|
27 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
You have to pay for EI services (post)
|
55 percentage of participants
|
35 percentage of participants
|
0 percentage of participants
|
6 percentage of participants
|
3 percentage of participants
|
0 percentage of participants
|
39 percentage of participants
|
45 percentage of participants
|
9 percentage of participants
|
3 percentage of participants
|
3 percentage of participants
|
0 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
EI services can be in home or daycare (pre)
|
6 percentage of participants
|
3 percentage of participants
|
3 percentage of participants
|
6 percentage of participants
|
51 percentage of participants
|
29 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
3 percentage of participants
|
6 percentage of participants
|
48 percentage of participants
|
42 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
EI services can be in home or daycare (post)
|
3 percentage of participants
|
3 percentage of participants
|
0 percentage of participants
|
6 percentage of participants
|
35 percentage of participants
|
52 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
15 percentage of participants
|
45 percentage of participants
|
39 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
I'm comfortable with EI staff in my home (pre)
|
6 percentage of participants
|
3 percentage of participants
|
3 percentage of participants
|
16 percentage of participants
|
29 percentage of participants
|
42 percentage of participants
|
0 percentage of participants
|
3 percentage of participants
|
3 percentage of participants
|
12 percentage of participants
|
48 percentage of participants
|
33 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
Resources like EI can help my family & I (post)
|
3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
10 percentage of participants
|
35 percentage of participants
|
52 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12 percentage of participants
|
58 percentage of participants
|
30 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
All learn to talk, walk, think @ same time (pre)
|
48 percentage of participants
|
35 percentage of participants
|
6 percentage of participants
|
10 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
52 percentage of participants
|
33 percentage of participants
|
9 percentage of participants
|
3 percentage of participants
|
0 percentage of participants
|
3 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
All learn to talk, walk, think @ same time (post)
|
42 percentage of participants
|
35 percentage of participants
|
3 percentage of participants
|
6 percentage of participants
|
3 percentage of participants
|
9 percentage of participants
|
52 percentage of participants
|
30 percentage of participants
|
9 percentage of participants
|
6 percentage of participants
|
3 percentage of participants
|
0 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
Longer to talk, walk, think may be delayed (pre)
|
10 percentage of participants
|
32 percentage of participants
|
10 percentage of participants
|
23 percentage of participants
|
19 percentage of participants
|
6 percentage of participants
|
9 percentage of participants
|
33 percentage of participants
|
21 percentage of participants
|
21 percentage of participants
|
6 percentage of participants
|
9 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
Longer to talk, walk, think may be delayed (post)
|
10 percentage of participants
|
10 percentage of participants
|
10 percentage of participants
|
23 percentage of participants
|
35 percentage of participants
|
13 percentage of participants
|
15 percentage of participants
|
30 percentage of participants
|
12 percentage of participants
|
33 percentage of participants
|
6 percentage of participants
|
3 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
All with delays get better on their own (pre)
|
19 percentage of participants
|
29 percentage of participants
|
6 percentage of participants
|
19 percentage of participants
|
19 percentage of participants
|
6 percentage of participants
|
3 percentage of participants
|
30 percentage of participants
|
15 percentage of participants
|
30 percentage of participants
|
15 percentage of participants
|
6 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
All with delays get better on their own (post)
|
16 percentage of participants
|
39 percentage of participants
|
10 percentage of participants
|
29 percentage of participants
|
3 percentage of participants
|
3 percentage of participants
|
18 percentage of participants
|
21 percentage of participants
|
21 percentage of participants
|
24 percentage of participants
|
9 percentage of participants
|
6 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
Behavior/Learning probs in school w/o help (pre)
|
10 percentage of participants
|
16 percentage of participants
|
6 percentage of participants
|
26 percentage of participants
|
29 percentage of participants
|
13 percentage of participants
|
6 percentage of participants
|
9 percentage of participants
|
12 percentage of participants
|
30 percentage of participants
|
27 percentage of participants
|
15 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
Behavior/Learning probs in school w/o help (post)
|
3 percentage of participants
|
3 percentage of participants
|
6 percentage of participants
|
13 percentage of participants
|
45 percentage of participants
|
29 percentage of participants
|
3 percentage of participants
|
0 percentage of participants
|
15 percentage of participants
|
30 percentage of participants
|
30 percentage of participants
|
21 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
Know more about child's develop than others (pre)
|
10 percentage of participants
|
10 percentage of participants
|
10 percentage of participants
|
19 percentage of participants
|
19 percentage of participants
|
32 percentage of participants
|
6 percentage of participants
|
24 percentage of participants
|
12 percentage of participants
|
33 percentage of participants
|
15 percentage of participants
|
9 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
Know more about child's develop than others (post)
|
10 percentage of participants
|
6 percentage of participants
|
6 percentage of participants
|
29 percentage of participants
|
29 percentage of participants
|
19 percentage of participants
|
6 percentage of participants
|
12 percentage of participants
|
15 percentage of participants
|
24 percentage of participants
|
27 percentage of participants
|
15 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
If delayed want to work with child on my own (pre)
|
23 percentage of participants
|
39 percentage of participants
|
10 percentage of participants
|
10 percentage of participants
|
16 percentage of participants
|
3 percentage of participants
|
9 percentage of participants
|
27 percentage of participants
|
24 percentage of participants
|
18 percentage of participants
|
21 percentage of participants
|
0 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
If delayed want to work with child on my own (pos)
|
23 percentage of participants
|
35 percentage of participants
|
16 percentage of participants
|
16 percentage of participants
|
3 percentage of participants
|
6 percentage of participants
|
6 percentage of participants
|
27 percentage of participants
|
21 percentage of participants
|
9 percentage of participants
|
18 percentage of participants
|
18 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
EI helps kids w/develop delay (post)
|
3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
13 percentage of participants
|
42 percentage of participants
|
42 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
18 percentage of participants
|
48 percentage of participants
|
33 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
You have to pay for EI services (pre)
|
23 percentage of participants
|
45 percentage of participants
|
13 percentage of participants
|
13 percentage of participants
|
6 percentage of participants
|
0 percentage of participants
|
27 percentage of participants
|
39 percentage of participants
|
21 percentage of participants
|
6 percentage of participants
|
6 percentage of participants
|
0 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
EI provider must come to home (pre)
|
13 percentage of participants
|
16 percentage of participants
|
16 percentage of participants
|
23 percentage of participants
|
19 percentage of participants
|
13 percentage of participants
|
9 percentage of participants
|
36 percentage of participants
|
18 percentage of participants
|
15 percentage of participants
|
12 percentage of participants
|
9 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
EI provider must come to home (post)
|
10 percentage of participants
|
23 percentage of participants
|
10 percentage of participants
|
23 percentage of participants
|
23 percentage of participants
|
13 percentage of participants
|
12 percentage of participants
|
7 percentage of participants
|
15 percentage of participants
|
21 percentage of participants
|
18 percentage of participants
|
6 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
Once EI starts you cannot stop (pre)
|
32 percentage of participants
|
35 percentage of participants
|
16 percentage of participants
|
3 percentage of participants
|
13 percentage of participants
|
0 percentage of participants
|
45 percentage of participants
|
36 percentage of participants
|
6 percentage of participants
|
3 percentage of participants
|
3 percentage of participants
|
6 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
Once EI starts you cannot stop (post)
|
48 percentage of participants
|
32 percentage of participants
|
6 percentage of participants
|
6 percentage of participants
|
3 percentage of participants
|
3 percentage of participants
|
39 percentage of participants
|
42 percentage of participants
|
9 percentage of participants
|
0 percentage of participants
|
6 percentage of participants
|
3 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
Studies show EI helps make progress (pre)
|
6 percentage of participants
|
3 percentage of participants
|
0 percentage of participants
|
13 percentage of participants
|
45 percentage of participants
|
32 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
6 percentage of participants
|
18 percentage of participants
|
58 percentage of participants
|
18 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
Studies show EI helps make progress (post)
|
3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
10 percentage of participants
|
42 percentage of participants
|
45 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
6 percentage of participants
|
9 percentage of participants
|
58 percentage of participants
|
27 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
Resources like EI can help my family & I (pre)
|
6 percentage of participants
|
0 percentage of participants
|
3 percentage of participants
|
13 percentage of participants
|
35 percentage of participants
|
42 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
9 percentage of participants
|
52 percentage of participants
|
39 percentage of participants
|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
I'm comfortable w/EI staff in my home (post)
|
3 percentage of participants
|
0 percentage of participants
|
6 percentage of participants
|
10 percentage of participants
|
39 percentage of participants
|
42 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
6 percentage of participants
|
12 percentage of participants
|
45 percentage of participants
|
36 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 7 daysPopulation: All survey data is presented collectively in Secondary Outcome Measure, "Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention". A separate analysis was not completed.
Parental uncertainty about whether to enroll their child in Early Intervention will be evaluated using a survey.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 7 daysPopulation: All survey data is presented collectively in Secondary Outcome Measure, "Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention". A separate analysis was not completed.
Parental predisposition for early intervention services will be measured using surveys.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 7 daysPopulation: Data was not collected regarding the time to complete PDA and/or number of Early Intervention referrals for the total population, thus data for this outcome measure was not able to be analyzed as outlined at the time of protocol development.
The feasibility of the patient decision aid (PDA) will be measured by calculating the number of individuals who refuse to participate, time that it takes to complete the PDA, and the number of patients who complete the Early Intervention referral.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 7 daysPopulation: Provider information was not collected as outlined in the initial protocol design. All survey data is presented collectively in Secondary Outcome Measure, "Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention". This includes elements of parent acceptability. A separate analysis was not completed.
The acceptability of using the patient decision aid for early intervention will be assessed by having patients and providers complete surveys on the intervention.
Outcome measures
Outcome data not reported
Adverse Events
Patient Decision Aid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Routine Care
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
Manuel Jimenez, MD, MS
Child Health Institute of New Jersey
Phone: 732-235-6230
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place