Trial Outcomes & Findings for Improving Outcomes for Low-Income Mothers With Depression (NCT NCT03221556)
NCT ID: NCT03221556
Last Updated: 2024-09-19
Results Overview
Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16). This scale is a 16-item self-report measure of depressive symptoms over the past 7 days. Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27. QIDS scores ≥11 suggest moderate depression.
COMPLETED
NA
231 participants
2 months
2024-09-19
Participant Flow
231 were randomized but there was 1 post-randomization exclusion in the PSE group resulting in a sample size of 230 participants.
Participant milestones
| Measure |
Engagement-Focused Care Coordination (EFCC)
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
|
|---|---|---|
|
Allocation
STARTED
|
115
|
116
|
|
Allocation
Received Allocated Intervention
|
88
|
96
|
|
Allocation
Did Not Receive Allocated Intervention
|
27
|
19
|
|
Allocation
COMPLETED
|
115
|
115
|
|
Allocation
NOT COMPLETED
|
0
|
1
|
|
Follow-Up
STARTED
|
115
|
115
|
|
Follow-Up
COMPLETED
|
115
|
114
|
|
Follow-Up
NOT COMPLETED
|
0
|
1
|
|
Analysis
STARTED
|
115
|
115
|
|
Analysis
Assessed at 2 Months
|
113
|
110
|
|
Analysis
Assessed at 4 Months
|
112
|
109
|
|
Analysis
Assessed at 6 Months
|
105
|
97
|
|
Analysis
Assessed at 8 Months
|
109
|
107
|
|
Analysis
Assessed at 10 Months
|
112
|
109
|
|
Analysis
Assessed at 12 Months
|
112
|
108
|
|
Analysis
COMPLETED
|
115
|
115
|
|
Analysis
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Engagement-Focused Care Coordination (EFCC)
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
|
|---|---|---|
|
Allocation
post-randomization exclusion
|
0
|
1
|
|
Follow-Up
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Improving Outcomes for Low-Income Mothers With Depression
Baseline characteristics by cohort
| Measure |
Engagement-Focused Care Coordination (EFCC)
n=115 Participants
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
n=115 Participants
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
|
Total
n=230 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
|
115 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
230 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
|
115 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
230 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
42 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
73 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
129 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/Ethnicity, Customized
White
|
9 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
68 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/Multi-race
|
23 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
115 participants
n=5 Participants
|
115 participants
n=7 Participants
|
230 participants
n=5 Participants
|
|
Moderate depression based on QIDS score ≥ 11
|
56 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Anxiety symptoms at baseline
|
14.9 score on a scale
STANDARD_DEVIATION 11.7 • n=5 Participants
|
15.7 score on a scale
STANDARD_DEVIATION 10.4 • n=7 Participants
|
15.3 score on a scale
STANDARD_DEVIATION 11.05 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: The overall number of participants analyzed reflects the numbers of participants in each group assessed for this outcome measure time frame as in the participant flow.
Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16). This scale is a 16-item self-report measure of depressive symptoms over the past 7 days. Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27. QIDS scores ≥11 suggest moderate depression.
Outcome measures
| Measure |
Engagement-Focused Care Coordination (EFCC)
n=113 Participants
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
n=110 Participants
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
|
|---|---|---|
|
Depression Symptoms at 2 Months (QIDS SR-16 ≥ 11)
|
32 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: The overall number of participants analyzed reflects the numbers of participants in each group assessed for this outcome measure time frame as in the participant flow.
Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16). This scale is a 16-item self-report measure of depressive symptoms over the past 7 days. Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27. QIDS scores ≥11 suggest moderate depression.
Outcome measures
| Measure |
Engagement-Focused Care Coordination (EFCC)
n=112 Participants
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
n=109 Participants
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
|
|---|---|---|
|
Depression Symptoms at 4 Months (QIDS SR-16 ≥ 11)
|
29 Participants
|
29 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The overall number of participants analyzed reflects the numbers of participants in each group assessed for this outcome measure time frame as in the participant flow.
Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16). This scale is a 16-item self-report measure of depressive symptoms over the past 7 days. Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27. QIDS scores ≥11 suggest moderate depression.
Outcome measures
| Measure |
Engagement-Focused Care Coordination (EFCC)
n=105 Participants
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
n=97 Participants
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
|
|---|---|---|
|
Depression Symptoms at 6 Months (QIDS SR-16 ≥ 11)
|
33 Participants
|
29 Participants
|
PRIMARY outcome
Timeframe: 8 monthsPopulation: The overall number of participants analyzed reflects the numbers of participants in each group assessed for this outcome measure time frame as in the participant flow.
Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16). This scale is a 16-item self-report measure of depressive symptoms over the past 7 days. Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27. QIDS scores ≥11 suggest moderate depression.
Outcome measures
| Measure |
Engagement-Focused Care Coordination (EFCC)
n=109 Participants
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
n=107 Participants
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
|
|---|---|---|
|
Depression Symptoms at 8 Months (QIDS SR-16 ≥ 11)
|
34 Participants
|
33 Participants
|
PRIMARY outcome
Timeframe: 10 monthsPopulation: The overall number of participants analyzed reflects the numbers of participants in each group assessed for this outcome measure time frame as in the participant flow.
Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16). This scale is a 16-item self-report measure of depressive symptoms over the past 7 days. Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27. QIDS scores ≥11 suggest moderate depression.
Outcome measures
| Measure |
Engagement-Focused Care Coordination (EFCC)
n=112 Participants
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
n=109 Participants
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
|
|---|---|---|
|
Depression Symptoms at 10 Months (QIDS SR-16 ≥ 11)
|
30 Participants
|
32 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The overall number of participants analyzed reflects the numbers of participants in each group assessed for this outcome measure time frame as in the participant flow.
Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16). This scale is a 16-item self-report measure of depressive symptoms over the past 7 days. Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27. QIDS scores ≥11 suggest moderate depression.
Outcome measures
| Measure |
Engagement-Focused Care Coordination (EFCC)
n=112 Participants
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
n=108 Participants
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
|
|---|---|---|
|
Depression Symptoms at 12 Months (QIDS SR-16 ≥ 11)
|
34 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: The overall number of participants analyzed reflects the numbers of participants in each group assessed for this outcome measure time frame as in the participant flow.
Assessed by the Beck Anxiety Inventory (BAI).This scale is a 21-item self-report measure of anxiety in the past 7 days. Each item is scored 0-3 (0 = not at all; 3 = severely - it bothered me a lot), yielding a total score range of 0 to 63. The lower the score the less self-reported anxiety.
Outcome measures
| Measure |
Engagement-Focused Care Coordination (EFCC)
n=113 Participants
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
n=110 Participants
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
|
|---|---|---|
|
Anxiety Symptoms at 2 Months
|
9.9 score on a scale
Standard Deviation 10.2
|
9.4 score on a scale
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: The overall number of participants analyzed reflects the numbers of participants in each group assessed for this outcome measure time frame as in the participant flow.
Assessed by the Beck Anxiety Inventory (BAI).This scale is a 21-item self-report measure of anxiety in the past 7 days. Each item is scored 0-3 (0 = not at all; 3 = severely - it bothered me a lot), yielding a total score range of 0 to 63. The lower the score the less self-reported anxiety.
Outcome measures
| Measure |
Engagement-Focused Care Coordination (EFCC)
n=112 Participants
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
n=109 Participants
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
|
|---|---|---|
|
Anxiety Symptoms at 4 Months
|
10.2 score on a scale
Standard Deviation 10.3
|
9.9 score on a scale
Standard Deviation 9.1
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The overall number of participants analyzed reflects the numbers of participants in each group assessed for this outcome measure time frame as in the participant flow.
Assessed by the Beck Anxiety Inventory (BAI).This scale is a 21-item self-report measure of anxiety in the past 7 days. Each item is scored 0-3 (0 = not at all; 3 = severely - it bothered me a lot), yielding a total score range of 0 to 63. The lower the score the less self-reported anxiety.
Outcome measures
| Measure |
Engagement-Focused Care Coordination (EFCC)
n=105 Participants
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
n=97 Participants
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
|
|---|---|---|
|
Anxiety Symptoms at 6 Months
|
10.9 score on a scale
Standard Deviation 11.0
|
11.4 score on a scale
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: 8 monthsPopulation: The overall number of participants analyzed reflects the numbers of participants in each group assessed for this outcome measure time frame as in the participant flow.
Assessed by the Beck Anxiety Inventory (BAI).This scale is a 21-item self-report measure of anxiety in the past 7 days. Each item is scored 0-3 (0 = not at all; 3 = severely - it bothered me a lot), yielding a total score range of 0 to 63. The lower the score the less self-reported anxiety.
Outcome measures
| Measure |
Engagement-Focused Care Coordination (EFCC)
n=109 Participants
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
n=107 Participants
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
|
|---|---|---|
|
Anxiety Symptoms at 8 Months
|
10.2 score on a scale
Standard Deviation 11.3
|
9.2 score on a scale
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: 10 monthsPopulation: The overall number of participants analyzed reflects the numbers of participants in each group assessed for this outcome measure time frame as in the participant flow.
Assessed by the Beck Anxiety Inventory (BAI).This scale is a 21-item self-report measure of anxiety in the past 7 days. Each item is scored 0-3 (0 = not at all; 3 = severely - it bothered me a lot), yielding a total score range of 0 to 63. The lower the score the less self-reported anxiety.
Outcome measures
| Measure |
Engagement-Focused Care Coordination (EFCC)
n=112 Participants
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
n=109 Participants
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
|
|---|---|---|
|
Anxiety Symptoms at 10 Months
|
9.8 score on a scale
Standard Deviation 10.4
|
10.0 score on a scale
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The overall number of participants analyzed reflects the numbers of participants in each group assessed for this outcome measure time frame as in the participant flow.
Assessed by the Beck Anxiety Inventory (BAI).This scale is a 21-item self-report measure of anxiety in the past 7 days. Each item is scored 0-3 (0 = not at all; 3 = severely - it bothered me a lot), yielding a total score range of 0 to 63. The lower the score the less self-reported anxiety.
Outcome measures
| Measure |
Engagement-Focused Care Coordination (EFCC)
n=112 Participants
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
n=108 Participants
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
|
|---|---|---|
|
Anxiety Symptoms at 12 Months
|
10.5 score on a scale
Standard Deviation 10.6
|
12.6 score on a scale
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: The overall number of participants analyzed reflects the numbers of participants in each group assessed for this outcome measure time frame as in the participant flow.
Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care.
Outcome measures
| Measure |
Engagement-Focused Care Coordination (EFCC)
n=113 Participants
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
n=110 Participants
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
|
|---|---|---|
|
Engaged With Care at 2 Months
|
15 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: The overall number of participants analyzed reflects the numbers of participants in each group assessed for this outcome measure time frame as in the participant flow.
Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care.
Outcome measures
| Measure |
Engagement-Focused Care Coordination (EFCC)
n=112 Participants
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
n=109 Participants
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
|
|---|---|---|
|
Engaged With Care at 4 Months
|
19 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The overall number of participants analyzed reflects the numbers of participants in each group assessed for this outcome measure time frame as in the participant flow.
Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care.
Outcome measures
| Measure |
Engagement-Focused Care Coordination (EFCC)
n=105 Participants
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
n=97 Participants
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
|
|---|---|---|
|
Engaged With Care at 6 Months
|
17 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 8 monthsPopulation: The overall number of participants analyzed reflects the numbers of participants in each group assessed for this outcome measure time frame as in the participant flow.
Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care.
Outcome measures
| Measure |
Engagement-Focused Care Coordination (EFCC)
n=109 Participants
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
n=107 Participants
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
|
|---|---|---|
|
Engaged With Care at 8 Months
|
17 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 10 monthsPopulation: The overall number of participants analyzed reflects the numbers of participants in each group assessed for this outcome measure time frame as in the participant flow.
Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care.
Outcome measures
| Measure |
Engagement-Focused Care Coordination (EFCC)
n=112 Participants
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
n=109 Participants
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
|
|---|---|---|
|
Engaged With Care at 10 Months
|
21 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The overall number of participants analyzed reflects the numbers of participants in each group assessed for this outcome measure time frame as in the participant flow.
Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care.
Outcome measures
| Measure |
Engagement-Focused Care Coordination (EFCC)
n=112 Participants
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
n=108 Participants
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
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|---|---|---|
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Engaged With Care at 12 Months
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22 Participants
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26 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The overall number of participants analyzed reflects the numbers of participants in each group assessed for this outcome measure time frame as in the participant flow.
Assessed by the Parenting Stress Index Short Form (PSI). This 36-item scale yields scores on three subscales - "parental distress", "parent-child dysfunctional interaction", and "difficult child" - which combine to form the total stress scale. Each item is scored 1-5 (1 = strongly agree; 5 = strongly disagree), yielding a scoring range of 36 to 180. Higher scores reflect more parent stress.
Outcome measures
| Measure |
Engagement-Focused Care Coordination (EFCC)
n=105 Participants
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
n=97 Participants
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
|
|---|---|---|
|
Parenting Behaviors at 6 Months
|
69.98 score on a scale
Standard Deviation 16.53
|
76.93 score on a scale
Standard Deviation 18.65
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The overall number of participants analyzed reflects the numbers of participants in each group assessed for this outcome measure time frame as in the participant flow.
Assessed by the Parenting Stress Index Short Form (PSI). This 36-item scale yields scores on three subscales - "parental distress", "parent-child dysfunctional interaction", and "difficult child" - which combine to form the total stress scale. Each item is scored 1-5 (1 = strongly agree; 5 = strongly disagree), yielding a scoring range of 36 to 180. Higher scores reflect more parent stress.
Outcome measures
| Measure |
Engagement-Focused Care Coordination (EFCC)
n=112 Participants
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
n=108 Participants
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
|
|---|---|---|
|
Parenting Behaviors at 12 Months
|
72.92 score on a scale
Standard Deviation 16.53
|
79.68 score on a scale
Standard Deviation 20.37
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The overall number of participants analyzed reflects the numbers of participants in each group assessed for this outcome measure time frame as in the participant flow.
Assessed by the Problem Focused Subscale of the Brief Coping Orientation to Problems Experienced Inventory (COPE). The overall COPE scale is a 28-item self-report measuring ways of coping with stress. Each item is scored 1-4 (1= I haven't been doing this at all; 4 = I've been doing this a lot). The Problem Focused Subscale includes 6 items focused on active coping, positive reframing, and planning. The scores for each question are added to total the subscale score, which ranges between 6-24 with lower scores indicating less problem-focused coping and higher scores indicating more problem focused coping.
Outcome measures
| Measure |
Engagement-Focused Care Coordination (EFCC)
n=105 Participants
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
n=97 Participants
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
|
|---|---|---|
|
Coping With Stress at 6 Months
|
13.22 score on a scale
Standard Deviation 4.22
|
13.66 score on a scale
Standard Deviation 3.94
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The overall number of participants analyzed reflects the numbers of participants in each group assessed for this outcome measure time frame as in the participant flow.
Assessed by the Problem Focused Subscale of the Brief COPE. The overall COPE scale is a 28-item self-report measuring ways of coping with stress. Each item is scored 1-4 (1= I haven't been doing this at all; 4 = I've been doing this a lot). The Problem Focused Subscale includes 6 items focused on active coping, positive reframing, and planning. The scores for each question are added to total the subscale score, which ranges between 6-24 with lower scores indicating less problem-focused coping and higher scores indicating more problem focused coping.
Outcome measures
| Measure |
Engagement-Focused Care Coordination (EFCC)
n=112 Participants
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
n=108 Participants
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
|
|---|---|---|
|
Coping With Stress at 12 Months
|
12.39 score on a scale
Standard Deviation 4.28
|
13.16 score on a scale
Standard Deviation 4.18
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The overall number of participants analyzed reflects the numbers of participants in each group assessed for this outcome measure time frame as in the participant flow.
Assessed by the Behavioral Activation for Depression Scale (BADS). This 25-item self-reported measure is used to track changes weekly in the behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation. The BADS subscales include activation, avoidance/rumination, work/school impairment, and social impairment. Each item is scored 0-6 (0=not at all; 6=completely), yielding a total score range of 0 to 150. High scores indicate greater levels of activation. For all the subscores, high scores are consistent with the subscale name.
Outcome measures
| Measure |
Engagement-Focused Care Coordination (EFCC)
n=105 Participants
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
n=97 Participants
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
|
|---|---|---|
|
Behavioral Activation for Depression at 6 Months
|
93.62 score on a scale
Standard Deviation 24.72
|
90.98 score on a scale
Standard Deviation 23.70
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The overall number of participants analyzed reflects the numbers of participants in each group assessed for this outcome measure time frame as in the participant flow.
Assessed by the Behavioral Activation for Depression Scale (BADS). This 25-item self-reported measure is used to track changes weekly in the behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation. The BADS subscales include activation, avoidance/rumination, work/school impairment, and social impairment. Each item is scored 0-6 (0=not at all; 6=completely), yielding a total score range of 0 to 150. High scores indicate greater levels of activation. For all the subscores, high scores are consistent with the subscale name.
Outcome measures
| Measure |
Engagement-Focused Care Coordination (EFCC)
n=112 Participants
The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services.
|
Problem Solving Education (PSE)
n=108 Participants
The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
|
|---|---|---|
|
Behavioral Activation for Depression at 12 Months
|
95.21 score on a scale
Standard Deviation 24.75
|
91.14 score on a scale
Standard Deviation 23.27
|
Adverse Events
Engagement-Focused Care Coordination (EFCC)
Problem Solving Education (PSE)
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