Trial Outcomes & Findings for The Parenting Young Children Check-up: Proof-of-Concept Trial (NCT NCT04113304)

Results Overview

One oral question, asking if parents intent to use the Parenting Young Children Check-up web-based resource, tapped into this outcome. Responses from participants were coded to reflect what percent of parents were interested in using the web-based resource, what percent of parent are not interested in using the web-based resource, and what percent are unsure.

Recruitment status

COMPLETED

Target enrollment

6 participants

Primary outcome timeframe

Baseline

Results posted on

2022-03-24

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Parenting Young Children Check-up: Proof-of-Concept Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=6 Participants Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up
Age, Continuous	27.83 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Two items (created for this project) were used to assess this outcome. Parents were asked their intentions to use the web-based resource (i.e., videos on the website). Items were rated on 5-point Likert scale (0 = Definitely Disagree, 4 = Definitely Agree). To create the final score, the two items were averaged with a possible range from 0-4 with higher scores indicating stronger intentions to use the Parenting Young Children Check-up web-based resource.

Outcome measures

Outcome measures
Measure	Intervention n=6 Participants Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up
Intentions to Use the Parenting Young Children Check-up Web-based Resource: Quantitative	3.25 score on a scale Interval 2.0 to 4.0

PRIMARY outcome

Timeframe: Baseline

One oral question, asking if parents intent to use the Parenting Young Children Check-up web-based resource, tapped into this outcome. Responses from participants were coded to reflect what percent of parents were interested in using the web-based resource, what percent of parent are not interested in using the web-based resource, and what percent are unsure.

Outcome measures

Outcome measures
Measure	Intervention n=6 Participants Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up
Intentions to Use the Parenting Young Children Check-up Web-based Resource: Qualitative Did not report intention to use program	0 Participants
Intentions to Use the Parenting Young Children Check-up Web-based Resource: Qualitative Reported intentions to use program	6 Participants

SECONDARY outcome

Timeframe: Baseline

Five questionnaire items (created for this project) were used to assess this outcome. Parents were asked about perceived ease of use of each part of the program. Each of the 5 items were rated on a 5-point Likert scale (0 = Definitely Disagree, 4 = Definitely Agree); higher scores indicate more perceived ease of use. An average ease of use score was computed by averaging the responses to the 5 items; the possible range was from 0-4 with higher scores indicate more ease of use).

Outcome measures

Outcome measures
Measure	Intervention n=6 Participants Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up
Perceived Ease of Use of the Parenting Young Children Check-up Program	3.40 score on a scale Interval 2.8 to 4.0

SECONDARY outcome

Timeframe: Baseline

Seven questionnaire items (created for this project) were used to assess this outcome. Parents were asked about perceived usefulness of each part of the program. Each of the 5 items were rated on a 5-point Likert scale (0 = Definitely Disagree, 4 = Definitely Agree); higher scores indicate more perceived ease of use. An average usefulness score was computed by averaging the responses to the 5 items; the possible range was from 0-4 with higher scores indicate more ease of use).

Outcome measures

Outcome measures
Measure	Intervention n=6 Participants Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up
Perceived Usefulness of the Parenting Young Children Check-up Program	3.52 score on a scale Interval 3.0 to 4.0

SECONDARY outcome

Timeframe: Baseline

Four questionnaire items (created for this project) tapped into this outcome. Parents were asked about how much they like each part of the program. Items were rated on a 5-point Likert scale (0 = Definitely Disagree, 4 = Definitely Agree); higher score indicated more likability. An average likability score was computed by taking the average of the 4 responses; possible range from 0-4 with higher scores indicate more likability.

Outcome measures

Outcome measures
Measure	Intervention n=6 Participants Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up
Likeability of the Parenting Young Children Check-up Program	3.63 score on a scale Interval 3.0 to 4.0

SECONDARY outcome

Timeframe: Baseline

One oral interview question ("Tell me your ideas about how to make the program better?') will tap into this outcome. Responses will be coded for specific suggestions to improve the Parenting Young Children Check-up program.

Outcome measures

Outcome measures
Measure	Intervention n=6 Participants Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up
Suggestions for Program Improvements No changes suggested	2 Participants
Suggestions for Program Improvements Suggested adding captioning to videos	1 Participants
Suggestions for Program Improvements Suggested giving out a pamphlet for the program	1 Participants
Suggestions for Program Improvements Suggested having in-person classes	1 Participants
Suggestions for Program Improvements Suggested changing voice of program narrator	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Between baseline and 3-months after

All participating parents will have an ID to access web-based parent training resources. The investigators will track to see who makes use of the resources; the frequency of use (n and % of families that use the web-based resource) will be reported.

Outcome measures

Outcome measures
Measure	Intervention n=6 Participants Parents went through the brief tablet-based intervention for the Parenting Young Children Check-up
Number of Participants That Use the Web-based Parent Training Resources Used web-based resource	0 Participants
Number of Participants That Use the Web-based Parent Training Resources Did not use web-based resource	6 Participants

Adverse Events

Intervention

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

Dr. Kathleen "Lucy" McGoron

Wayne State University

Phone: 313.664.2500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place