Trial Outcomes & Findings for Examine the Feasibility and Acceptability of Project Support (NCT NCT06391229)
NCT ID: NCT06391229
Last Updated: 2026-07-15
Results Overview
Supportive Parenting scale includes 3 items (e.g,. "you praise your child if he/she behaves well") made on a 5-point scale (0 = never, 1 = almost never, 2 = sometime, 3 = often, 4 = always). Scale ranges from 0 to 12. Item responses are summed. Higher scores indicate a better outcome of more supportive parenting.
COMPLETED
NA
32 participants
Baseline to Post-test (6 weeks)
2026-07-15
Participant Flow
Protocol enrollment represents the number of total participants enrolled (caregivers and their child). The Milestones within the Participant Flow report individual children and caregivers, although they participated as dyads.
Participant milestones
| Measure |
Project Support - Caregivers
All caregivers will receive the Project Support intervention over the course of 4-6 weeks.
|
Project Support - Children
Children completed baseline measures and outcome measures; their caregiver received the Project Support intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Project Support - Caregivers
All caregivers will receive the Project Support intervention over the course of 4-6 weeks.
|
Project Support - Children
Children completed baseline measures and outcome measures; their caregiver received the Project Support intervention.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
Baseline Characteristics
Only caregivers completed this measure.
Baseline characteristics by cohort
| Measure |
Project Support - Caregivers
n=16 Participants
All caregivers will receive the Project Support intervention over the course of 4-6 weeks.
|
Project Support - Children
n=16 Participants
Children completed baseline measures and outcome measures; their caregiver received the Project Support intervention.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=16 Participants
|
16 Participants
n=16 Participants
|
16 Participants
n=32 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=16 Participants
|
0 Participants
n=16 Participants
|
15 Participants
n=32 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=16 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=32 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=16 Participants
|
10 Participants
n=16 Participants
|
26 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=16 Participants
|
6 Participants
n=16 Participants
|
6 Participants
n=32 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=16 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=32 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=16 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=32 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=16 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=32 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=16 Participants
|
4 Participants
n=16 Participants
|
7 Participants
n=32 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=16 Participants
|
8 Participants
n=16 Participants
|
17 Participants
n=32 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=16 Participants
|
1 Participants
n=16 Participants
|
2 Participants
n=32 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=16 Participants
|
3 Participants
n=16 Participants
|
6 Participants
n=32 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=16 Participants
|
3 Participants
n=16 Participants
|
6 Participants
n=32 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=16 Participants
|
13 Participants
n=16 Participants
|
26 Participants
n=32 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=16 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=32 Participants
|
|
Supportive Parenting assessed by the Alabama Parenting Questionnaire
|
9.00 Scores on a scale
STANDARD_DEVIATION 2.13 • n=16 Participants
|
9.50 Scores on a scale
STANDARD_DEVIATION 2.00 • n=16 Participants
|
9.25 Scores on a scale
STANDARD_DEVIATION 1.63 • n=32 Participants
|
|
Parenting self-efficacy assessed by the Parenting Sense of Competence Scale
|
32.35 Scores on a scale
STANDARD_DEVIATION 5.21 • n=16 Participants • Only caregivers completed this measure.
|
—
|
32.35 Scores on a scale
STANDARD_DEVIATION 5.21 • n=16 Participants • Only caregivers completed this measure.
|
|
Hopefulness assessed by the Beck Hopelessness Scale-4
|
2.06 Scores on a scale
STANDARD_DEVIATION 2.17 • n=16 Participants • Only caregivers completed this measure.
|
—
|
2.06 Scores on a scale
STANDARD_DEVIATION 2.17 • n=16 Participants • Only caregivers completed this measure.
|
|
Child psychological distress assessed by the Pediatric Symptom Checklist
|
14.69 Scores on a scale
STANDARD_DEVIATION 5.74 • n=16 Participants
|
13.88 Scores on a scale
STANDARD_DEVIATION 5.94 • n=16 Participants
|
14.28 Scores on a scale
STANDARD_DEVIATION 4.67 • n=32 Participants
|
PRIMARY outcome
Timeframe: Baseline to Post-test (6 weeks)Population: Of the n = 16 dyads assigned to the Project Support condition, n = 11 dyads (caregivers and children) completed the post-test assessment 6 weeks later.
Supportive Parenting scale includes 3 items (e.g,. "you praise your child if he/she behaves well") made on a 5-point scale (0 = never, 1 = almost never, 2 = sometime, 3 = often, 4 = always). Scale ranges from 0 to 12. Item responses are summed. Higher scores indicate a better outcome of more supportive parenting.
Outcome measures
| Measure |
Project Support - Caregivers
n=11 Participants
All caregivers will receive the Project Support intervention over the course of 4-6 weeks.
|
Project Support - Child
n=11 Participants
Children completed baseline measures and outcome measures; their caregiver received the Project Support intervention.
|
|---|---|---|
|
Supportive Parenting Assessed by the Alabama Parenting Questionnaire
|
9.36 Scores on a scale
Standard Deviation 1.63
|
9.27 Scores on a scale
Standard Deviation 2.49
|
PRIMARY outcome
Timeframe: Baseline to Post-test (6 weeks)Population: Of the n = 16 caregivers assigned to the Project Support condition, n = 11 completed the post-test assessment 6 weeks later. Only caregivers completed the measure of parenting self-efficacy.
Parenting self-efficacy subscale includes 8 items (e.g., "If anyone can find the answer to what is troubling my child, I am the one") made on a 6-point scale (1 = strongly disagree to 6 = strongly agree). Scale ranges from 8 to 48. Item responses are summed. Higher scores indicate better outcome of greater parenting self-efficacy.
Outcome measures
| Measure |
Project Support - Caregivers
n=11 Participants
All caregivers will receive the Project Support intervention over the course of 4-6 weeks.
|
Project Support - Child
Children completed baseline measures and outcome measures; their caregiver received the Project Support intervention.
|
|---|---|---|
|
Parenting Self-efficacy Assessed by the Parenting Sense of Competence Scale
|
35.55 Scores on a scale
Standard Deviation 5.94
|
—
|
PRIMARY outcome
Timeframe: Baseline to Post-test (6 weeks)Population: Of the n = 16 caregivers assigned to the Project Support condition, n = 11 completed the post-test assessment 6 weeks later. Only caregivers completed this outcome measure of hopelessness.
The Beck Hopelessness Scale-4 includes 4 items measuring hopelessness (e.g., "I feel the future is hopeless and that things cannot improve") made on a 4-point scale (0 = not typical, 1 = rarely typical, 2 = typical, 3 = very typical). Scale ranges from 0 to 12. Item responses are summed. Higher scores indicate worse outcomes in that they represent a higher degree of hopelessness.
Outcome measures
| Measure |
Project Support - Caregivers
n=11 Participants
All caregivers will receive the Project Support intervention over the course of 4-6 weeks.
|
Project Support - Child
Children completed baseline measures and outcome measures; their caregiver received the Project Support intervention.
|
|---|---|---|
|
Hopefulness Assessed by the Beck Hopelessness Scale-4
|
1.36 Scores on a scale
Standard Deviation 2.50
|
—
|
SECONDARY outcome
Timeframe: Baseline to Post-test (6 weeks)Population: Of the n = 16 dyads assigned to the Project Support condition, n = 11 dyads (caregivers and children) completed the post-test assessment 6 weeks later.
The total problems scale on the Pediatric Symptom Checklist includes 17 items measuring child psychological distress (e.g., "Feels sad, unhappy") made on a 3-point scale (0 = never, 1 = sometimes, 2 = often). Scale ranges from 0 to 34. Item responses are summed. Higher scores indicate worse outcomes in that they represent higher psychological distress.
Outcome measures
| Measure |
Project Support - Caregivers
n=11 Participants
All caregivers will receive the Project Support intervention over the course of 4-6 weeks.
|
Project Support - Child
n=11 Participants
Children completed baseline measures and outcome measures; their caregiver received the Project Support intervention.
|
|---|---|---|
|
Child Psychological Distress Assessed by the Pediatric Symptom Checklist
|
12.18 Scores on a scale
Standard Deviation 6.49
|
11.09 Scores on a scale
Standard Deviation 6.92
|
Adverse Events
Project Support - Caregivers
Project Support - Children
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Caitlin Rancher (Principal Investigator)
Medical University of South Carolina
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place