Trial Outcomes & Findings for Feasibility Trial of the TELL Tool Intervention (NCT NCT04841967)
NCT ID: NCT04841967
Last Updated: 2024-01-11
Results Overview
Participant's report of current state of disclosure to their child or children. Total score range = 1 (disclosed) 2 (not-disclosed)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
Disclosure assessed at 4-week time point. Data for the 12-week time point was missing due to a technology issue.
Results posted on
2024-01-11
Participant Flow
Participant milestones
| Measure |
TELL Tool Group
Parents in the TELL Tool group will complete a decision support aid that has four interactive, multimedia and multicomponent modules that will be administered digitally. It will take parents about 60 minutes to complete the TELL Tool.
TELL Tool Intervention: A 60-minute session with decision support information delivered digitally to parents at their homes or other private, quiet location.
|
eBook Attention-Control
Parents in the eBook attention-control group will complete one interactive, multimedia and multicomponent program that contains information about good parenting principles and is administered digitally. It will take parents about 60 minutes to complete the eBook attention control.
eBook Attention Control: A 60-minute session with good parenting principles delivered digitally to parents at their homes or other private, quiet location.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
34
|
|
Overall Study
Recruitment Goal Achieved
|
41
|
34
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
11
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility Trial of the TELL Tool Intervention
Baseline characteristics by cohort
| Measure |
TELL Tool Group
n=41 Participants
Parents in the TELL Tool group will complete a decision support aid that has four interactive, multimedia and multicomponent modules that will be administered digitally. It will take parents about 60 minutes to complete the TELL Tool.
TELL Tool Intervention: A 60-minute session with decision support information delivered digitally to parents at their homes or other private, quiet location.
|
eBook Attention-Control
n=34 Participants
Parents in the eBook attention-control group will complete one interactive, multimedia and multicomponent program that contains information about good parenting principles and is administered digitally. It will take parents about 60 minutes to complete the eBook attention control.
eBook Attention Control: A 60-minute session with good parenting principles delivered digitally to parents at their homes or other private, quiet location.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
34 participants
n=7 Participants
|
75 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Disclosure assessed at 4-week time point. Data for the 12-week time point was missing due to a technology issue.Participant's report of current state of disclosure to their child or children. Total score range = 1 (disclosed) 2 (not-disclosed)
Outcome measures
| Measure |
TELL Tool Group
n=30 Participants
Parents in the TELL Tool group will complete a decision support aid that has four interactive, multimedia and multicomponent modules that will be administered digitally. It will take parents about 60 minutes to complete the TELL Tool.
TELL Tool Intervention: A 60-minute session with decision support information delivered digitally to parents at their homes or other private, quiet location.
|
eBook Attention-Control
n=30 Participants
Parents in the eBook attention-control group will complete one interactive, multimedia and multicomponent program that contains information about good parenting principles and is administered digitally. It will take parents about 60 minutes to complete the eBook attention control.
eBook Attention Control: A 60-minute session with good parenting principles delivered digitally to parents at their homes or other private, quiet location.
|
|---|---|---|
|
Number of Participants Who Disclosed the Donor Conception to Their Children
|
23 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Baseline-Change in Disclosure Intention at Immediate posttest-Month 1-Month 3Parent's report on the Survey about Parents' Disclosure Intention. No score range (13 items)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline-Change in Disclosure Competence at Immediate posttest-Month 1-Month 3Parent's report on the Perceived Competence Scale. Total score range = 4 (worse) to 28 (better)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline-Change in Disclosure Anxiety at Immediate posttest-Month 1-Month 3Parent's report on the Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety - Computer Adapted Test (CAT). Total scores for CAT will be comparable across participants.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediate posttestParticipant's reports to the Acceptability Survey. No score range (19 items)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 15Participant's responses to the Cognitive Interviews. No score range (Cognitive Interview Guide for Acceptability)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Before baselineParticipant's (8 to 12 participants who are not part of the pilot randomized controlled trial) responses to Cognitive Interviews. No score range. (Cognitive Interview Guide for Measures)
Outcome measures
Outcome data not reported
Adverse Events
TELL Tool Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
eBook Attention-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