Trial Outcomes & Findings for Improving Quality of Care in Child Mental Health Service Settings (NCT NCT03305458)
NCT ID: NCT03305458
Last Updated: 2025-06-06
Results Overview
Child engagement will be measured via coding of audiotaped sessions by independent, trained raters who are blind to study purpose and hypotheses. The Child Involvement Ratings Scale (CIRS) will be used to code child engagement. Ten "child involvement" items-6 positive, 4 negative- are rated for each session on a 6-point scale. The minimum total score will be 0 and the maximum score is 50. For the outcome, a single average value will be presented. The positive-involvement items emphasize the extent to which children initiate discussions, demonstrate enthusiasm, self-disclose, and demonstrate understanding. Negative-involvement items address withdrawal or avoidance in treatment. Coders provide ratings based on two 10-min segments of session audiotapes (beginning at min 10 and min 40). Screening was conducted on enrolled participants.
COMPLETED
NA
713 participants
3 Month Timeline
2025-06-06
Participant Flow
Participant milestones
| Measure |
Treatment as Usual
Trauma Focused Cognitive Behavioral Therapy
TFCBT: treatment as usual
|
Tablet-Facilitated TF-CBT
Standard treatment with the addition of in-treatment/session iPad activities
eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
Not Randomized
Enrolled Providers will be randomized as soon as a family they referred enrolled into the study. Families did not enroll into the study or provider did not send a referral
|
|---|---|---|---|
|
Overall Study
STARTED
|
273
|
326
|
128
|
|
Overall Study
COMPLETED
|
138
|
195
|
0
|
|
Overall Study
NOT COMPLETED
|
135
|
131
|
128
|
Reasons for withdrawal
| Measure |
Treatment as Usual
Trauma Focused Cognitive Behavioral Therapy
TFCBT: treatment as usual
|
Tablet-Facilitated TF-CBT
Standard treatment with the addition of in-treatment/session iPad activities
eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
Not Randomized
Enrolled Providers will be randomized as soon as a family they referred enrolled into the study. Families did not enroll into the study or provider did not send a referral
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
50
|
46
|
93
|
|
Overall Study
Lost to Follow-up
|
85
|
85
|
35
|
Baseline Characteristics
Improving Quality of Care in Child Mental Health Service Settings
Baseline characteristics by cohort
| Measure |
Treatment as Usual
n=273 Participants
Trauma Focused Cognitive Behavioral Therapy
TFCBT: treatment as usual
|
Tablet-Facilitated TF-CBT
n=326 Participants
Standard treatment with the addition of in-treatment/session iPad activities
eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
Not Randomized
n=128 Participants
As per the protocol, enrolled Providers will be randomized as soon as their family referral was enrolled into the study. Unfortunately the families they referred never enrolled into the study, or enrolled providers did not send a referral.
|
Total
n=727 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
117 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
258 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
148 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
454 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Age, Continuous
|
12.0 years
STANDARD_DEVIATION 2.38 • n=5 Participants
|
11.4 years
STANDARD_DEVIATION 2.38 • n=7 Participants
|
36 years
STANDARD_DEVIATION 8.32 • n=5 Participants
|
11.7 years
STANDARD_DEVIATION 2.38 • n=4 Participants
|
|
Sex: Female, Male
Female
|
215 Participants
n=5 Participants
|
262 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
593 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
234 Participants
n=5 Participants
|
276 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
622 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
9 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
99 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
227 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
147 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
414 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
38 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
234 Participants
n=5 Participants
|
276 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
622 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
273 Participants
n=5 Participants
|
326 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
727 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 Month TimelinePopulation: Measure was used on enrolled participants (Children).
Child engagement will be measured via coding of audiotaped sessions by independent, trained raters who are blind to study purpose and hypotheses. The Child Involvement Ratings Scale (CIRS) will be used to code child engagement. Ten "child involvement" items-6 positive, 4 negative- are rated for each session on a 6-point scale. The minimum total score will be 0 and the maximum score is 50. For the outcome, a single average value will be presented. The positive-involvement items emphasize the extent to which children initiate discussions, demonstrate enthusiasm, self-disclose, and demonstrate understanding. Negative-involvement items address withdrawal or avoidance in treatment. Coders provide ratings based on two 10-min segments of session audiotapes (beginning at min 10 and min 40). Screening was conducted on enrolled participants.
Outcome measures
| Measure |
Treatment as Usual
n=62 Participants
Trauma Focused Cognitive Behavioral Therapy
TFCBT: treatment as usual
|
Tablet-Facilitated TF-CBT
n=49 Participants
Standard treatment with the addition of in-treatment/session iPad activities
eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
Not Randomized
As per the protocol, enrolled Providers will be randomized as soon as their family referral was enrolled into the study. Unfortunately the families they referred never enrolled into the study, or enrolled providers did not send a referral.
|
|---|---|---|---|
|
Child Involvement Ratings Scale (CIRS)
|
1.95 units on a scale
Standard Deviation .69
|
2.01 units on a scale
Standard Deviation .70
|
—
|
PRIMARY outcome
Timeframe: 3 Month TimelinePopulation: Measure was used on enrolled Randomized Providers
Fidelity to the TF-CBT protocol will be measured by independent, trained raters who are blind to the study purpose and hypotheses, coding audiotaped treatment sessions. The TF-CBT Version of the Therapy Process Observational Coding System for Child Psychotherapy (TF-CBT TPOCS-S), modified for the eTF-CBT condition, will be used to assess provider fidelity to each TF-CBT component. Two raters will review video-recorded treatment sessions, assessing the presence or absence of specific techniques and rating their extensiveness on a 6-point scale. The total score will range from a minimum of 0 to the maximum 78. The outcome will be presented as a single average value.
Outcome measures
| Measure |
Treatment as Usual
n=33 Participants
Trauma Focused Cognitive Behavioral Therapy
TFCBT: treatment as usual
|
Tablet-Facilitated TF-CBT
n=31 Participants
Standard treatment with the addition of in-treatment/session iPad activities
eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
Not Randomized
As per the protocol, enrolled Providers will be randomized as soon as their family referral was enrolled into the study. Unfortunately the families they referred never enrolled into the study, or enrolled providers did not send a referral.
|
|---|---|---|---|
|
Provider Treatment Fidelity (TPOCS)
|
.50 units on a scale
Standard Deviation .21
|
.43 units on a scale
Standard Deviation .24
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 Month, 6 Month, 9 Month, 12 MonthPopulation: We encountered several challenges in conducting this study. First, some enrolled participants (caregivers and children) requested to discontinue their participation. Second, we experienced a high rate of loss to follow-up due to changes in contact information, such as disconnected phone numbers or children moving to a different foster home.
assesses the severity of depressive symptomatology in children. It is a 20-item self-report measure with possible scores ranging from 0-60. Each questions has a scaling score of 0-3. With 0 being the lowest value stating 'Not at all' and 3 being the highest value stating 'A lot'. Total score over 15 is indicative of significant levels of depressive symptoms, showing worse outcome.
Outcome measures
| Measure |
Treatment as Usual
n=117 Participants
Trauma Focused Cognitive Behavioral Therapy
TFCBT: treatment as usual
|
Tablet-Facilitated TF-CBT
n=142 Participants
Standard treatment with the addition of in-treatment/session iPad activities
eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
Not Randomized
As per the protocol, enrolled Providers will be randomized as soon as their family referral was enrolled into the study. Unfortunately the families they referred never enrolled into the study, or enrolled providers did not send a referral.
|
|---|---|---|---|
|
Center for Epidemiological Studies Depression Scale for Children (CES-DC)
6 Month Timeline
|
19.22 score on a scale
Standard Deviation 9.88
|
18.91 score on a scale
Standard Deviation 10.21
|
—
|
|
Center for Epidemiological Studies Depression Scale for Children (CES-DC)
Baseline Timeline
|
25.21 score on a scale
Standard Deviation 12.32
|
23.61 score on a scale
Standard Deviation 11.86
|
—
|
|
Center for Epidemiological Studies Depression Scale for Children (CES-DC)
3 Month Timeline
|
20.88 score on a scale
Standard Deviation 11.44
|
20.66 score on a scale
Standard Deviation 11.92
|
—
|
|
Center for Epidemiological Studies Depression Scale for Children (CES-DC)
9 Month Timeline
|
18.35 score on a scale
Standard Deviation 9.35
|
19.33 score on a scale
Standard Deviation 10.73
|
—
|
|
Center for Epidemiological Studies Depression Scale for Children (CES-DC)
12 Month Timeline
|
16 score on a scale
Standard Deviation 10.02
|
18.76 score on a scale
Standard Deviation 11.152
|
—
|
SECONDARY outcome
Timeframe: 3 MonthPopulation: At this point of time number of participant analyzed did drop due to participants discontinuing from the study or were missed at this time point.
The Therapeutic Alliance Score for Children is a 12-item measure of the child's alliance with the therapist using a 4-pt scale. It has good internal consistency and interrupter reliability. Measuring therapeutic alliance is one of the most reliable ways to determine the strength of this bond, and it allows the therapist to identify how comfortable their client might be in sharing their thoughts, experiences, struggles and goals with them throughout care. This scale completed by the adolescent participant aged 12-18, and there is a parallel version for the therapist to complete. Each item is rated on a 4 point scale ranging with 0 being the lowest value 'not at all' to 3 the highest value 'very much'. The lowest possible total score being 0 and the highest possible score (total score) would be 36. The higher the total score represents better outcome showing the strength of the child and therapist bond.
Outcome measures
| Measure |
Treatment as Usual
n=83 Participants
Trauma Focused Cognitive Behavioral Therapy
TFCBT: treatment as usual
|
Tablet-Facilitated TF-CBT
n=117 Participants
Standard treatment with the addition of in-treatment/session iPad activities
eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
Not Randomized
As per the protocol, enrolled Providers will be randomized as soon as their family referral was enrolled into the study. Unfortunately the families they referred never enrolled into the study, or enrolled providers did not send a referral.
|
|---|---|---|---|
|
Therapeutic Alliance Scale for Children (TASC)
|
21.27 score on a scale
Standard Deviation 3.73
|
20.67 score on a scale
Standard Deviation 3.34
|
—
|
SECONDARY outcome
Timeframe: 3 MonthThe Child/Adolescent Satisfaction Questionnaire is a 15-item instrument that assesses child satisfaction with mental health treatment. The last three questions are open ended questions that do not provide value (these will not be measured/scored). The first twelve questions have a scoring scale between 1-5, with 1 being the lowest value ('Very much False') and 5 being the highest value with ('Very much True'). The total minimum score is 12 and the maximum total score being 60. The higher the total score represents a better outcome. Screening was given to enrolled children.
Outcome measures
| Measure |
Treatment as Usual
n=83 Participants
Trauma Focused Cognitive Behavioral Therapy
TFCBT: treatment as usual
|
Tablet-Facilitated TF-CBT
n=117 Participants
Standard treatment with the addition of in-treatment/session iPad activities
eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
Not Randomized
As per the protocol, enrolled Providers will be randomized as soon as their family referral was enrolled into the study. Unfortunately the families they referred never enrolled into the study, or enrolled providers did not send a referral.
|
|---|---|---|---|
|
Child/Adolescent Satisfaction Questionnaire (CASQ).
|
51.20 score on a scale
Standard Deviation 8.01
|
50.91 score on a scale
Standard Deviation 8.79
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 Month, 6 Month, 9 Month, 12 MonthPopulation: We encountered several challenges in conducting this study. First, some enrolled participants (caregivers and children) requested to discontinue their participation. Second, we experienced a high rate of loss to follow-up due to changes in contact information, such as disconnected phone numbers or children moving to a different foster home.
4-item instrument that assesses feelings of shame following abuse. With a score ranging 0-2, 0 being the lowest value 'Not true' and 2 being the highest value 'Very true'. The lowest possible total score is 0 and the highest possible total score is 8. The higher the score meant a worse outcome. Screening completed by enrolled children.
Outcome measures
| Measure |
Treatment as Usual
n=117 Participants
Trauma Focused Cognitive Behavioral Therapy
TFCBT: treatment as usual
|
Tablet-Facilitated TF-CBT
n=142 Participants
Standard treatment with the addition of in-treatment/session iPad activities
eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
Not Randomized
As per the protocol, enrolled Providers will be randomized as soon as their family referral was enrolled into the study. Unfortunately the families they referred never enrolled into the study, or enrolled providers did not send a referral.
|
|---|---|---|---|
|
The Shame Measure
Baseline Timeline
|
2.40 score on a scale
Standard Deviation 2.23
|
2.08 score on a scale
Standard Deviation 2.23
|
—
|
|
The Shame Measure
3 Month Timeline
|
1.58 score on a scale
Standard Deviation 1.77
|
1.54 score on a scale
Standard Deviation 2.01
|
—
|
|
The Shame Measure
6 Month Timeline
|
1.34 score on a scale
Standard Deviation 1.77
|
1.34 score on a scale
Standard Deviation 1.94
|
—
|
|
The Shame Measure
9 Month Timeline
|
1.21 score on a scale
Standard Deviation 1.60
|
1.07 score on a scale
Standard Deviation 1.71
|
—
|
|
The Shame Measure
12 Month Timeline
|
1.02 score on a scale
Standard Deviation 1.81
|
1.14 score on a scale
Standard Deviation 1.78
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 Month, 6 Month, 9 Month, 12 MonthPopulation: We encountered several challenges in conducting this study. First, some enrolled participants (caregivers and children) requested to discontinue their participation. Second, we experienced a high rate of loss to follow-up due to changes in contact information, such as disconnected phone numbers or children moving to a different foster home.
35-item instrument that assesses exposure to traumatic events and all 20 Diagnostic and Statistical Manual of Mental Disorder- Fifth Edition, Symptoms of PTSD. 20 items are scored ranging total value of 0-60; the minimum total score being 0 and the maximum total score being 60. Values ranging between 0-3, with the lowest possible score of 0 being 'Not at All' and 3 being the highest with 'All the time.' The higher values represent a worst outcome. Screenings complete with enrolled children.
Outcome measures
| Measure |
Treatment as Usual
n=117 Participants
Trauma Focused Cognitive Behavioral Therapy
TFCBT: treatment as usual
|
Tablet-Facilitated TF-CBT
n=142 Participants
Standard treatment with the addition of in-treatment/session iPad activities
eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
Not Randomized
As per the protocol, enrolled Providers will be randomized as soon as their family referral was enrolled into the study. Unfortunately the families they referred never enrolled into the study, or enrolled providers did not send a referral.
|
|---|---|---|---|
|
The Child and Adolescent Trauma Screen (CATS) - Youth Version
Baseline Timeline
|
21.50 score on a scale
Standard Deviation 13.03
|
21.66 score on a scale
Standard Deviation 13.59
|
—
|
|
The Child and Adolescent Trauma Screen (CATS) - Youth Version
3 Month Timeline
|
16.33 score on a scale
Standard Deviation 11.58
|
16.83 score on a scale
Standard Deviation 13.50
|
—
|
|
The Child and Adolescent Trauma Screen (CATS) - Youth Version
6 Month Timeline
|
13.74 score on a scale
Standard Deviation 11.06
|
14.51 score on a scale
Standard Deviation 11.95
|
—
|
|
The Child and Adolescent Trauma Screen (CATS) - Youth Version
9 Month Timeline
|
13.09 score on a scale
Standard Deviation 12.39
|
12.10 score on a scale
Standard Deviation 11.97
|
—
|
|
The Child and Adolescent Trauma Screen (CATS) - Youth Version
12 Month Timeline
|
10.57 score on a scale
Standard Deviation 11.61
|
12.33 score on a scale
Standard Deviation 11.26
|
—
|
SECONDARY outcome
Timeframe: 3 MonthPopulation: Caregiver completed these assessments for each of their children. There are a number of parents that completed this assessment multiple times for each of their children who were enrolled.
The Caregiver Satisfaction Questionnaire is a 15-item instrument that assesses caregiver satisfaction with mental health treatment. The last three questions are open ended questions that do not provide value (these will not be measured/scored). The first twelve questions have a scoring scale between 1-5, with 1 being the lowest value ('Very much False') and 5 being the highest value with ('Very much True').The minimum total score being 12 and the maximum total scores being 60. The higher the score represents a better outcome. Assessment given to only enrolled parent/caregivers and children. Screening was completed by enrolled caregivers/parents.
Outcome measures
| Measure |
Treatment as Usual
n=79 Participants
Trauma Focused Cognitive Behavioral Therapy
TFCBT: treatment as usual
|
Tablet-Facilitated TF-CBT
n=120 Participants
Standard treatment with the addition of in-treatment/session iPad activities
eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
Not Randomized
As per the protocol, enrolled Providers will be randomized as soon as their family referral was enrolled into the study. Unfortunately the families they referred never enrolled into the study, or enrolled providers did not send a referral.
|
|---|---|---|---|
|
Caregiver Satisfaction Questionnaire (CSQ)
|
52.46 score on a scale
Standard Deviation 7.64
|
52.79 score on a scale
Standard Deviation 8.67
|
—
|
SECONDARY outcome
Timeframe: 3 Month TimelineThe WAI is a 12-item measure of the parent-therapist alliance using a 7-point scale (never to always). Scoring ranging between 1-7, with 1 being the lowest ('Never') and 7 being the highest with ('Always'). Total scores ranging between 12-84. Screening was completed by enrolled caregivers/parents. Higher score indicate a better therapeutic alliance.
Outcome measures
| Measure |
Treatment as Usual
n=82 Participants
Trauma Focused Cognitive Behavioral Therapy
TFCBT: treatment as usual
|
Tablet-Facilitated TF-CBT
n=116 Participants
Standard treatment with the addition of in-treatment/session iPad activities
eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
Not Randomized
As per the protocol, enrolled Providers will be randomized as soon as their family referral was enrolled into the study. Unfortunately the families they referred never enrolled into the study, or enrolled providers did not send a referral.
|
|---|---|---|---|
|
Working Alliance Inventory (WAI-short Form)
|
51.4 score on a scale
Standard Deviation 7.85
|
51.03 score on a scale
Standard Deviation 8.73
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 Month, 6 Month, 9 Month, 12 MonthPopulation: We encountered several challenges in conducting this study. First, some enrolled participants (caregivers and children) requested to discontinue their participation. Second, we experienced a high rate of loss to follow-up due to changes in contact information, such as disconnected phone numbers or children moving to a different foster home.
The BPM is a 19-item measure of emotional and behavioral functioning in children. The BPM is well-validated and comparable to the lengthier Child Behavior Checklist. The values range from 0-2 with 0 being the lowest value of 'Not True' and 2 being the highest value of 'Very True'. The lowest possible total score is 0 and the total highest possible score being 38. The higher the total score the worse outcome. Screening was completed with enrolled caregivers/parents.
Outcome measures
| Measure |
Treatment as Usual
n=117 Participants
Trauma Focused Cognitive Behavioral Therapy
TFCBT: treatment as usual
|
Tablet-Facilitated TF-CBT
n=142 Participants
Standard treatment with the addition of in-treatment/session iPad activities
eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
Not Randomized
As per the protocol, enrolled Providers will be randomized as soon as their family referral was enrolled into the study. Unfortunately the families they referred never enrolled into the study, or enrolled providers did not send a referral.
|
|---|---|---|---|
|
Brief Problems Monitor (BPM)
Baseline Timeline
|
14.5 score on a scale
Standard Deviation 7.78
|
14.9 score on a scale
Standard Deviation 7.62
|
—
|
|
Brief Problems Monitor (BPM)
3 Month Timeline
|
12.1 score on a scale
Standard Deviation 8.07
|
13.3 score on a scale
Standard Deviation 8.48
|
—
|
|
Brief Problems Monitor (BPM)
6 Month Timeline
|
10.6 score on a scale
Standard Deviation 8.94
|
12.7 score on a scale
Standard Deviation 8.74
|
—
|
|
Brief Problems Monitor (BPM)
9 Month Timeline
|
11.0 score on a scale
Standard Deviation 8.99
|
12.1 score on a scale
Standard Deviation 9.00
|
—
|
|
Brief Problems Monitor (BPM)
12 Month Timeline
|
9.8 score on a scale
Standard Deviation 8.99
|
11.9 score on a scale
Standard Deviation 7.97
|
—
|
SECONDARY outcome
Timeframe: baseline, 3, 6, 9, 12 months TimelinePopulation: We encountered several challenges in conducting this study. First, some enrolled participants (caregivers and children) requested to discontinue their participation. Second, we experienced a high rate of loss to follow-up due to changes in contact information, such as disconnected phone numbers or children moving to a different foster home.
The Center for Epidemiologic Studies Depression Scale is a 20-item self-report scale of depression completed by the enrolled caregiver. It is widely used and demonstrates excellent psychometric properties. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. A score equal to or above 15 indicates a person at risk for clinical depression. Enrolled caregivers had multiple children enrolled meaning that caregivers with multiple children were asked more than once for each time point.
Outcome measures
| Measure |
Treatment as Usual
n=117 Participants
Trauma Focused Cognitive Behavioral Therapy
TFCBT: treatment as usual
|
Tablet-Facilitated TF-CBT
n=142 Participants
Standard treatment with the addition of in-treatment/session iPad activities
eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
Not Randomized
As per the protocol, enrolled Providers will be randomized as soon as their family referral was enrolled into the study. Unfortunately the families they referred never enrolled into the study, or enrolled providers did not send a referral.
|
|---|---|---|---|
|
Center for Epidemiologic Studies Depression Scale (CESD-R).
Baseline
|
17.94 score on a scale
Standard Deviation 14.59
|
18.28 score on a scale
Standard Deviation 13.25
|
—
|
|
Center for Epidemiologic Studies Depression Scale (CESD-R).
3 Month Timeline
|
14.77 score on a scale
Standard Deviation 13.71
|
16.23 score on a scale
Standard Deviation 12.61
|
—
|
|
Center for Epidemiologic Studies Depression Scale (CESD-R).
6 Month Timeline
|
12.94 score on a scale
Standard Deviation 12.99
|
23.88 score on a scale
Standard Deviation 86.44
|
—
|
|
Center for Epidemiologic Studies Depression Scale (CESD-R).
9 Month Timeline
|
14.6 score on a scale
Standard Deviation 12.80
|
15.62 score on a scale
Standard Deviation 13.87
|
—
|
|
Center for Epidemiologic Studies Depression Scale (CESD-R).
12 Month Timeline
|
12.66 score on a scale
Standard Deviation 12.90
|
14.91 score on a scale
Standard Deviation 13.49
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 Month, 6 Month, 9 Month, 12 MonthPopulation: We encountered several challenges in conducting this study. First, some enrolled participants (caregivers and children) requested to discontinue their participation. Second, we experienced a high rate of loss to follow-up due to changes in contact information, such as disconnected phone numbers or children moving to a different foster home.
35-item parent version of the CATS-Youth. CATS are given to enrolled Caregivers. A total symptom score is calculated by summing up the raw scores of items 1-20 (possible range = 0-60). The lowest value score of 0 being 'Never' and the highest value of 3 'Almost Always.' We recommend to use a cut-off ≥ 21 as indication of a clinically relevant level of symptoms. The higher the score means a worse outcome. Screening completed by enrolled caregiver/parents. Enrolled caregivers had multiple children enrolled meaning that caregivers with multiple children were asked more than once for each time point.
Outcome measures
| Measure |
Treatment as Usual
n=117 Participants
Trauma Focused Cognitive Behavioral Therapy
TFCBT: treatment as usual
|
Tablet-Facilitated TF-CBT
n=142 Participants
Standard treatment with the addition of in-treatment/session iPad activities
eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
Not Randomized
As per the protocol, enrolled Providers will be randomized as soon as their family referral was enrolled into the study. Unfortunately the families they referred never enrolled into the study, or enrolled providers did not send a referral.
|
|---|---|---|---|
|
The Child and Adolescent Trauma Screen (CATS) - Caregiver Version
Baseline
|
21.16 score on a scale
Standard Deviation 12.64
|
20.27 score on a scale
Standard Deviation 12.65
|
—
|
|
The Child and Adolescent Trauma Screen (CATS) - Caregiver Version
3 Month
|
13.80 score on a scale
Standard Deviation 11.43
|
16.70 score on a scale
Standard Deviation 12.26
|
—
|
|
The Child and Adolescent Trauma Screen (CATS) - Caregiver Version
6 Month
|
13.95 score on a scale
Standard Deviation 12.57
|
13.85 score on a scale
Standard Deviation 12.09
|
—
|
|
The Child and Adolescent Trauma Screen (CATS) - Caregiver Version
9 Month
|
13.62 score on a scale
Standard Deviation 13.92
|
13.80 score on a scale
Standard Deviation 12.23
|
—
|
|
The Child and Adolescent Trauma Screen (CATS) - Caregiver Version
12 Month
|
10.22 score on a scale
Standard Deviation 12.37
|
12.92 score on a scale
Standard Deviation 12.06
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 Month, 6 Month, 9 Month, 12 MonthPopulation: We encountered several challenges in conducting this study. First, some enrolled participants (caregivers and children) requested to discontinue their participation. Second, we experienced a high rate of loss to follow-up due to changes in contact information, such as disconnected phone numbers or children moving to a different foster home.
42-item measure to assess parenting practices. 13 questions were pulled to be utilized in these assessments. Scoring ranges are from 1- 5: 1 being 'Never', 2 being 'Almost never', 3 being 'Sometimes, 4 being 'Often', and 5 being 'Always'. Total minimum score being 13 and the highest possible score being 65. The higher score means worse outcome. With Assessment was given to Enrolled Caregivers/parents. Enrolled caregivers had multiple children enrolled meaning that caregivers with multiple children were asked more than once for each time point.
Outcome measures
| Measure |
Treatment as Usual
n=117 Participants
Trauma Focused Cognitive Behavioral Therapy
TFCBT: treatment as usual
|
Tablet-Facilitated TF-CBT
n=142 Participants
Standard treatment with the addition of in-treatment/session iPad activities
eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
Not Randomized
As per the protocol, enrolled Providers will be randomized as soon as their family referral was enrolled into the study. Unfortunately the families they referred never enrolled into the study, or enrolled providers did not send a referral.
|
|---|---|---|---|
|
The Alabama Parenting Questionnaire
Baseline Timeline
|
43.72 score on a scale
Standard Deviation 6.12
|
44.37 score on a scale
Standard Deviation 6.23
|
—
|
|
The Alabama Parenting Questionnaire
3 Month
|
43.26 score on a scale
Standard Deviation 5.27
|
45.18 score on a scale
Standard Deviation 5.87
|
—
|
|
The Alabama Parenting Questionnaire
6 Month
|
43.44 score on a scale
Standard Deviation 4.80
|
44.39 score on a scale
Standard Deviation 6.32
|
—
|
|
The Alabama Parenting Questionnaire
9 Month
|
43.33 score on a scale
Standard Deviation 6.82
|
44.31 score on a scale
Standard Deviation 6.52
|
—
|
|
The Alabama Parenting Questionnaire
12 Month
|
43.05 score on a scale
Standard Deviation 6.48
|
43.54 score on a scale
Standard Deviation 5.81
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 Month, 6 Month, 9 Month, 12 MonthPopulation: We encountered several challenges in conducting this study. First, some enrolled participants (caregivers and children) requested to discontinue their participation. Second, we experienced a high rate of loss to follow-up due to changes in contact information, such as disconnected phone numbers or children moving to a different foster home.
Widely used the Kessler 6 measure of general distress that is well-validated. Assessment was given to Enrolled Caregivers.There are 6 items that are asked and each value scores ranging 0-4, with 0 being 'none of the time' and 4 being 'All of the time". With minimum total score would be 0 and maximum score would be 24. According to the scoring criteria proposed by Kessler 6, persons with a score of 13 or greater are likely to be experiencing severe mental illness. The higher total score represented a worse outcome. Screening was completed by enrolled caregivers/parents. Enrolled caregivers had multiple children enrolled meaning that caregivers with multiple children were asked more than once for each time point.
Outcome measures
| Measure |
Treatment as Usual
n=117 Participants
Trauma Focused Cognitive Behavioral Therapy
TFCBT: treatment as usual
|
Tablet-Facilitated TF-CBT
n=142 Participants
Standard treatment with the addition of in-treatment/session iPad activities
eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
Not Randomized
As per the protocol, enrolled Providers will be randomized as soon as their family referral was enrolled into the study. Unfortunately the families they referred never enrolled into the study, or enrolled providers did not send a referral.
|
|---|---|---|---|
|
The Kessler 6
Baseline Timeline
|
6.10 score on a scale
Standard Deviation 5.49
|
6.33 score on a scale
Standard Deviation 5.44
|
—
|
|
The Kessler 6
3 Month Timeline
|
4.86 score on a scale
Standard Deviation 4.94
|
5.48 score on a scale
Standard Deviation 4.70
|
—
|
|
The Kessler 6
6 Month Timeline
|
4.96 score on a scale
Standard Deviation 5.26
|
5.42 score on a scale
Standard Deviation 4.80
|
—
|
|
The Kessler 6
9 Month Timeline
|
5.05 score on a scale
Standard Deviation 4.92
|
5.60 score on a scale
Standard Deviation 5.24
|
—
|
|
The Kessler 6
12 Month Time
|
4.25 score on a scale
Standard Deviation 4.84
|
5.40 score on a scale
Standard Deviation 5.59
|
—
|
SECONDARY outcome
Timeframe: baseline, post baseline at 12 MonthsPopulation: We encountered several challenges in conducting this study. First, some enrolled participants (enrolled providers) requested to discontinue their participation. Second, we experienced a high rate of loss to follow-up due to changes in contact information, such as disconnected phone numbers or no longer working with the agency/clinic
15 items, assessing providers' perceptions of appeal of Evidence-Based Therapy, openness to innovation, perceived divergence with usual care (alphas .59-.90; M=.77).Scoring ranges from 0-4, with 0 being the lowest value ('Not at all') and 4 being the highest value ('To a Very Great Extent'). With the minimum score being 0 and the maximum score being 60. The higher Evidence-Based Practice Attitude Scale total score indicating more global positive attitudes toward adoption of Evidence-Based Practice.The higher the value reprents a better outcome. This assessment was given to enrolled providers.
Outcome measures
| Measure |
Treatment as Usual
n=48 Participants
Trauma Focused Cognitive Behavioral Therapy
TFCBT: treatment as usual
|
Tablet-Facilitated TF-CBT
n=53 Participants
Standard treatment with the addition of in-treatment/session iPad activities
eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
Not Randomized
n=126 Participants
As per the protocol, enrolled Providers will be randomized as soon as their family referral was enrolled into the study. Unfortunately the families they referred never enrolled into the study, or enrolled providers did not send a referral.
|
|---|---|---|---|
|
Evidence-Based Practice Attitude Scale (EBPAS)
Baseline
|
38.35 units on a scale
Standard Deviation 6.21
|
38.83 units on a scale
Standard Deviation 6.14
|
36.16 units on a scale
Standard Deviation 6.90
|
|
Evidence-Based Practice Attitude Scale (EBPAS)
Post Baseline at 12 months
|
39.39 units on a scale
Standard Deviation 7.28
|
36.91 units on a scale
Standard Deviation 7.66
|
35.19 units on a scale
Standard Deviation 6.99
|
SECONDARY outcome
Timeframe: Baseline, Post Baseline at 12 monthsAssess understanding of the application of behavioral principles to youth. With the minimum score of 0 and maximum score of 25. the higher values represent a better outcome. Internal consistency=.42-.84; sensitivity to change. Screening completed with Enrolled Providers.
Outcome measures
| Measure |
Treatment as Usual
n=48 Participants
Trauma Focused Cognitive Behavioral Therapy
TFCBT: treatment as usual
|
Tablet-Facilitated TF-CBT
n=53 Participants
Standard treatment with the addition of in-treatment/session iPad activities
eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
Not Randomized
n=126 Participants
As per the protocol, enrolled Providers will be randomized as soon as their family referral was enrolled into the study. Unfortunately the families they referred never enrolled into the study, or enrolled providers did not send a referral.
|
|---|---|---|---|
|
Knowledge of Behavioral Principles as Applied to Children
Baseline
|
48 Participants
|
53 Participants
|
123 Participants
|
|
Knowledge of Behavioral Principles as Applied to Children
Post Baseline at 12 months
|
27 Participants
|
35 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: baseline, Post baseline at 12 monthsPopulation: We encountered several challenges in conducting this study. First, some enrolled participants (enrolled providers) requested to discontinue their participation. Second, we experienced a high rate of loss to follow-up due to changes in contact information, such as disconnected phone numbers or no longer working with the agency/clinic
12-item measure to monitor and evaluate implementation efforts. This measure has been shown to have solid psychometric properties. Scaling is ranged from 1 to 5, with 1 being the lowest value with ('Completely Disagree') and 5 being the highest value ('Completely Agree'). With the total possible score ranging 12-60. With the lowest possible total score being 12 and the highest possible score being 60. The higher the values represent a better outcome. The higher scores indicate greater acceptability, appropriateness, and feasibility. Screening completed with enrolled providers.
Outcome measures
| Measure |
Treatment as Usual
n=48 Participants
Trauma Focused Cognitive Behavioral Therapy
TFCBT: treatment as usual
|
Tablet-Facilitated TF-CBT
n=53 Participants
Standard treatment with the addition of in-treatment/session iPad activities
eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
Not Randomized
n=117 Participants
As per the protocol, enrolled Providers will be randomized as soon as their family referral was enrolled into the study. Unfortunately the families they referred never enrolled into the study, or enrolled providers did not send a referral.
|
|---|---|---|---|
|
Acceptability, Appropriateness and Feasibility Measure (AIMIAMFIM)
Baseline
|
53.94 units on a scale
Standard Deviation 6.64
|
55.66 units on a scale
Standard Deviation 5.40
|
52.10 units on a scale
Standard Deviation 6.22
|
|
Acceptability, Appropriateness and Feasibility Measure (AIMIAMFIM)
Post Baseline at 12 months
|
44.26 units on a scale
Standard Deviation 7.40
|
52.86 units on a scale
Standard Deviation 6.96
|
47.19 units on a scale
Standard Deviation 8.58
|
SECONDARY outcome
Timeframe: baseline, post baseline at 12 monthsPopulation: We encountered several challenges in conducting this study. First, some enrolled participants (enrolled providers) requested to discontinue their participation. Second, we experienced a high rate of loss to follow-up due to changes in contact information, such as disconnected phone numbers or no longer working with the agency/clinic
8-item measure design to assess attitudes toward computer use in treatment. Scaling on each question ranges 1-5 with 1 being the lowest value ('Strongly Disagree') and 5 being the highest value ('Strongly Agree'). The minimum total score would be 8 and the maximum total score being 40. The higher the value represents a better outcome. Assessment given only to enrolled providers.
Outcome measures
| Measure |
Treatment as Usual
n=48 Participants
Trauma Focused Cognitive Behavioral Therapy
TFCBT: treatment as usual
|
Tablet-Facilitated TF-CBT
n=53 Participants
Standard treatment with the addition of in-treatment/session iPad activities
eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
Not Randomized
n=125 Participants
As per the protocol, enrolled Providers will be randomized as soon as their family referral was enrolled into the study. Unfortunately the families they referred never enrolled into the study, or enrolled providers did not send a referral.
|
|---|---|---|---|
|
Computer Assisted Therapy Attitudes Scale
Baseline
|
21.90 units on a scale
Standard Deviation 3.36
|
19.79 units on a scale
Standard Deviation 3.26
|
21.13 units on a scale
Standard Deviation 2.87
|
|
Computer Assisted Therapy Attitudes Scale
Post Baseline
|
20.96 units on a scale
Standard Deviation 3.09
|
18.97 units on a scale
Standard Deviation 3.45
|
20.67 units on a scale
Standard Deviation 2.90
|
SECONDARY outcome
Timeframe: baseline, post baseline at 12 monthsPopulation: We encountered several challenges in conducting this study. First, some enrolled participants (enrolled providers) requested to discontinue their participation. Second, we experienced a high rate of loss to follow-up due to changes in contact information, such as disconnected phone numbers or no longer working with the agency/clinic
12-item measure designed to assess an organization's readiness to implement new policies, programs, and practices. With values ranging between 1-5, 1 being the lowest of 'Disagree' and 5 being the highest with 'Agree'. The total minimum score being 12 and total maximum number being 60. The higher values represent a better outcome. Lower scores represent less organizational readiness for implementing change; Higher scores represent a more favorable organizational readiness for implementing change
Outcome measures
| Measure |
Treatment as Usual
n=48 Participants
Trauma Focused Cognitive Behavioral Therapy
TFCBT: treatment as usual
|
Tablet-Facilitated TF-CBT
n=53 Participants
Standard treatment with the addition of in-treatment/session iPad activities
eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
Not Randomized
n=126 Participants
As per the protocol, enrolled Providers will be randomized as soon as their family referral was enrolled into the study. Unfortunately the families they referred never enrolled into the study, or enrolled providers did not send a referral.
|
|---|---|---|---|
|
Organizational Readiness for Implementing Change
Baseline
|
53.29 units on a scale
Standard Deviation 7.15
|
51.87 units on a scale
Standard Deviation 8.13
|
20.37 units on a scale
Standard Deviation 7.87
|
|
Organizational Readiness for Implementing Change
Post Baseline at 12 month
|
46.57 units on a scale
Standard Deviation 9.75
|
48.65 units on a scale
Standard Deviation 9.74
|
47.13 units on a scale
Standard Deviation 11.25
|
SECONDARY outcome
Timeframe: baseline, post baseline at 12 monthPopulation: We encountered several challenges in conducting this study. First, some enrolled participants (enrolled providers) requested to discontinue their participation. Second, we experienced a high rate of loss to follow-up due to changes in contact information, such as disconnected phone numbers or no longer working with the agency/clinic
19-item instrument to assess a community mental health organization's activities related to the delivery of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT). With values ranging between 1-5. 1 being the lowest with ' Strongly Disagree' and 5 being the highest with 'strongly agree'. The total minimum scores being 19 and the total maximum total scores being 95. The higher values represent a better outcome. Screening given to enrolled providers.
Outcome measures
| Measure |
Treatment as Usual
n=48 Participants
Trauma Focused Cognitive Behavioral Therapy
TFCBT: treatment as usual
|
Tablet-Facilitated TF-CBT
n=53 Participants
Standard treatment with the addition of in-treatment/session iPad activities
eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
Not Randomized
n=126 Participants
As per the protocol, enrolled Providers will be randomized as soon as their family referral was enrolled into the study. Unfortunately the families they referred never enrolled into the study, or enrolled providers did not send a referral.
|
|---|---|---|---|
|
TF-CBT Organizational Support Measure
baseline
|
62.96 units on a scale
Standard Deviation 4.89
|
61.75 units on a scale
Standard Deviation 7.80
|
62.48 units on a scale
Standard Deviation 6.41
|
|
TF-CBT Organizational Support Measure
post baseline at 12 month
|
63.63 units on a scale
Standard Deviation 6.05
|
63.43 units on a scale
Standard Deviation 8.32
|
61.02 units on a scale
Standard Deviation 7.95
|
SECONDARY outcome
Timeframe: baselinescreener that assesses providers' feelings about their work, and their perceptions of how their co-workers feel about the work they do. Scorings will range from 4- 28. Scaling value between 1-7, with 1 being the lowest value of 'Never' and 7 with the highest value of 'everyday'. Higher scores will mean worse outcome. Screening complete by enrolled providers.
Outcome measures
| Measure |
Treatment as Usual
n=27 Participants
Trauma Focused Cognitive Behavioral Therapy
TFCBT: treatment as usual
|
Tablet-Facilitated TF-CBT
n=31 Participants
Standard treatment with the addition of in-treatment/session iPad activities
eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
Not Randomized
n=87 Participants
As per the protocol, enrolled Providers will be randomized as soon as their family referral was enrolled into the study. Unfortunately the families they referred never enrolled into the study, or enrolled providers did not send a referral.
|
|---|---|---|---|
|
Burnout Measure
|
10.11 units on a scale
Standard Deviation 4.14
|
10.12 units on a scale
Standard Deviation 4.10
|
10.17 units on a scale
Standard Deviation 4.22
|
Adverse Events
Treatment as Usual
Tablet-Facilitated TF-CBT
Not Randomized
Serious adverse events
| Measure |
Treatment as Usual
n=267 participants at risk
Trauma Focused Cognitive Behavioral Therapy
TFCBT: treatment as usual
|
Tablet-Facilitated TF-CBT
n=320 participants at risk
Standard treatment with the addition of in-treatment/session iPad activities
eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
Not Randomized
n=126 participants at risk
Providers who are enrolled into the study but did not have a family enrolled.
|
|---|---|---|---|
|
Investigations
Suicide Ideations
|
0.37%
1/267 • Number of events 1 • 52 weeks, 1 year
Adverse events were monitored and assessed by our clinical supervisors.
|
0.00%
0/320 • 52 weeks, 1 year
Adverse events were monitored and assessed by our clinical supervisors.
|
0.00%
0/126 • 52 weeks, 1 year
Adverse events were monitored and assessed by our clinical supervisors.
|
|
Investigations
Self Harm
|
0.37%
1/267 • Number of events 1 • 52 weeks, 1 year
Adverse events were monitored and assessed by our clinical supervisors.
|
0.00%
0/320 • 52 weeks, 1 year
Adverse events were monitored and assessed by our clinical supervisors.
|
0.00%
0/126 • 52 weeks, 1 year
Adverse events were monitored and assessed by our clinical supervisors.
|
|
Investigations
Caregiver Death
|
0.00%
0/267 • 52 weeks, 1 year
Adverse events were monitored and assessed by our clinical supervisors.
|
1.2%
4/320 • Number of events 4 • 52 weeks, 1 year
Adverse events were monitored and assessed by our clinical supervisors.
|
0.00%
0/126 • 52 weeks, 1 year
Adverse events were monitored and assessed by our clinical supervisors.
|
Other adverse events
| Measure |
Treatment as Usual
n=267 participants at risk
Trauma Focused Cognitive Behavioral Therapy
TFCBT: treatment as usual
|
Tablet-Facilitated TF-CBT
n=320 participants at risk
Standard treatment with the addition of in-treatment/session iPad activities
eTFCBT: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
|
Not Randomized
n=126 participants at risk
Providers who are enrolled into the study but did not have a family enrolled.
|
|---|---|---|---|
|
Investigations
Suicide Ideation/ Self Harm
|
2.6%
7/267 • Number of events 7 • 52 weeks, 1 year
Adverse events were monitored and assessed by our clinical supervisors.
|
2.8%
9/320 • Number of events 9 • 52 weeks, 1 year
Adverse events were monitored and assessed by our clinical supervisors.
|
0.00%
0/126 • 52 weeks, 1 year
Adverse events were monitored and assessed by our clinical supervisors.
|
|
Psychiatric disorders
Patient taken to a Inpatient Clinic
|
0.37%
1/267 • Number of events 1 • 52 weeks, 1 year
Adverse events were monitored and assessed by our clinical supervisors.
|
1.9%
6/320 • Number of events 6 • 52 weeks, 1 year
Adverse events were monitored and assessed by our clinical supervisors.
|
0.00%
0/126 • 52 weeks, 1 year
Adverse events were monitored and assessed by our clinical supervisors.
|
|
Investigations
Informing Therapist
|
1.5%
4/267 • Number of events 4 • 52 weeks, 1 year
Adverse events were monitored and assessed by our clinical supervisors.
|
1.2%
4/320 • Number of events 4 • 52 weeks, 1 year
Adverse events were monitored and assessed by our clinical supervisors.
|
0.00%
0/126 • 52 weeks, 1 year
Adverse events were monitored and assessed by our clinical supervisors.
|
|
Investigations
DSS Reports
|
1.1%
3/267 • Number of events 3 • 52 weeks, 1 year
Adverse events were monitored and assessed by our clinical supervisors.
|
0.62%
2/320 • Number of events 2 • 52 weeks, 1 year
Adverse events were monitored and assessed by our clinical supervisors.
|
0.00%
0/126 • 52 weeks, 1 year
Adverse events were monitored and assessed by our clinical supervisors.
|
Additional Information
Dr. Tatiana Davidson
Medical University of South Carolina
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place