Trial Outcomes & Findings for Improving Satisfaction, Engagement and Outcomes Among Traditionally Underserved Children Through Cultural Formulation (NCT NCT03499600)
NCT ID: NCT03499600
Last Updated: 2023-04-07
Results Overview
The CFI Clinician Questionnaire is a 4-item measure developed designed to assess clinical utility of the CFI. Items are rated on a 5-point Likert style scale ranging from 1='not at all' to 5='very much'. Each item has a minimum score of 1 and a max of 5. Items include the extent to which conducting the CFI influences content and quality of information obtained in the intake, realtionship with the caregiver, treatment planning, and differential diagnosis. Higher scores indicate higher levels of clinical utility of the CFI. The measure was given only to the CA + CFI condition. This analysis was utilized to assess for initial utility of the CFI and was mistakenly entered into the system as a primary outcome variable. This measure is not used to determine the effect of an experimental variable on participants in the study. Statistical analyses for this measure were descriptive and only examined for the experimental group.
COMPLETED
NA
89 participants
Post Intake Assessment (Week 0)
2023-04-07
Participant Flow
Families were recruited and randomized from August 2017 to October 2018; data collection continued through May 2019. Recruitment and data collection during the provision of clinical services within three community clinics that were embedded within neighborhood centers regularly accessed by the community (i.e., afterschool care centers, family and neighborhood resource programs).
Caregivers and children were considered enrolled in the current study. Caregivers were recruited based on their participation in a parenting intervention for their child. The Enrollment number and number of participants Started/Completed represents the number of dyads (caregiver+child). For example, 39 caregivers started treatment with their child in the CA+CFI group and 50 caregivers started treatment with their child in the CA only group.
Participant milestones
| Measure |
Clinical Assessment and CFI
CA and CFI families will receive the Cultural Formulation Interview prior to their standard Clinical Assessment during their intake.
Clinical Assessment and CFI: CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.
|
Clinical Assessment Only
CA families will receive a standard Clinical Assessment during intake.
Clinical Assessment: CA families will participate their standard intake procedures.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
50
|
|
Overall Study
COMPLETED
|
18
|
20
|
|
Overall Study
NOT COMPLETED
|
21
|
30
|
Reasons for withdrawal
| Measure |
Clinical Assessment and CFI
CA and CFI families will receive the Cultural Formulation Interview prior to their standard Clinical Assessment during their intake.
Clinical Assessment and CFI: CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.
|
Clinical Assessment Only
CA families will receive a standard Clinical Assessment during intake.
Clinical Assessment: CA families will participate their standard intake procedures.
|
|---|---|---|
|
Overall Study
Caregiver/child dyad dropped out before completing a full course of treatment
|
21
|
30
|
Baseline Characteristics
CA + CFI group = 39 caregivers and 39 children (39 caregiver/child dyads). CA only group = 50 caregivers and 50 children (50 caregiver/child dyads)
Baseline characteristics by cohort
| Measure |
Clinical Assessment and CFI
n=78 Participants
CA and CFI families will receive the Cultural Formulation Interview prior to their standard Clinical Assessment during their intake.
Clinical Assessment and CFI: CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.
|
Clinical Assessment Only
n=100 Participants
CA families will receive a standard Clinical Assessment during intake.
Clinical Assessment: CA families will participate their standard intake procedures.
|
Total
n=178 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Child Age
|
5.2 years
STANDARD_DEVIATION 1.6 • n=39 Participants • CA + CFI group = 39 caregivers and 39 children (39 caregiver/child dyads). CA only group = 50 caregivers and 50 children (50 caregiver/child dyads)
|
5.03 years
STANDARD_DEVIATION 1.5 • n=50 Participants • CA + CFI group = 39 caregivers and 39 children (39 caregiver/child dyads). CA only group = 50 caregivers and 50 children (50 caregiver/child dyads)
|
5.1 years
STANDARD_DEVIATION 1.6 • n=89 Participants • CA + CFI group = 39 caregivers and 39 children (39 caregiver/child dyads). CA only group = 50 caregivers and 50 children (50 caregiver/child dyads)
|
|
Age, Continuous
Caregiver Age
|
35.1 years
STANDARD_DEVIATION 7.4 • n=39 Participants • CA + CFI group = 39 caregivers and 39 children (39 caregiver/child dyads). CA only group = 50 caregivers and 50 children (50 caregiver/child dyads)
|
33.8 years
STANDARD_DEVIATION 70 • n=50 Participants • CA + CFI group = 39 caregivers and 39 children (39 caregiver/child dyads). CA only group = 50 caregivers and 50 children (50 caregiver/child dyads)
|
34.4 years
STANDARD_DEVIATION 7.2 • n=89 Participants • CA + CFI group = 39 caregivers and 39 children (39 caregiver/child dyads). CA only group = 50 caregivers and 50 children (50 caregiver/child dyads)
|
|
Sex: Female, Male
Child Sex · Female
|
11 Participants
n=39 Participants • We only have sex data available for the child, not the caregiver. There are n=39 children in the CA+CFI group and n=50 children in the CA only group.
|
17 Participants
n=50 Participants • We only have sex data available for the child, not the caregiver. There are n=39 children in the CA+CFI group and n=50 children in the CA only group.
|
28 Participants
n=89 Participants • We only have sex data available for the child, not the caregiver. There are n=39 children in the CA+CFI group and n=50 children in the CA only group.
|
|
Sex: Female, Male
Child Sex · Male
|
28 Participants
n=39 Participants • We only have sex data available for the child, not the caregiver. There are n=39 children in the CA+CFI group and n=50 children in the CA only group.
|
33 Participants
n=50 Participants • We only have sex data available for the child, not the caregiver. There are n=39 children in the CA+CFI group and n=50 children in the CA only group.
|
61 Participants
n=89 Participants • We only have sex data available for the child, not the caregiver. There are n=39 children in the CA+CFI group and n=50 children in the CA only group.
|
|
Race (NIH/OMB)
Child Race · American Indian or Alaska Native
|
1 Participants
n=39 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
0 Participants
n=50 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
1 Participants
n=89 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
|
Race (NIH/OMB)
Child Race · Asian
|
1 Participants
n=39 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
0 Participants
n=50 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
1 Participants
n=89 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
|
Race (NIH/OMB)
Child Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
0 Participants
n=50 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
0 Participants
n=89 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
|
Race (NIH/OMB)
Child Race · Black or African American
|
11 Participants
n=39 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
8 Participants
n=50 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
19 Participants
n=89 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
|
Race (NIH/OMB)
Child Race · White
|
22 Participants
n=39 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
34 Participants
n=50 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
56 Participants
n=89 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
|
Race (NIH/OMB)
Child Race · More than one race
|
4 Participants
n=39 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
4 Participants
n=50 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
8 Participants
n=89 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
|
Race (NIH/OMB)
Child Race · Unknown or Not Reported
|
0 Participants
n=39 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
4 Participants
n=50 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
4 Participants
n=89 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
|
Race (NIH/OMB)
Primary Caregiver Race · American Indian or Alaska Native
|
1 Participants
n=39 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
0 Participants
n=50 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
1 Participants
n=89 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
|
Race (NIH/OMB)
Primary Caregiver Race · Asian
|
1 Participants
n=39 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
0 Participants
n=50 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
1 Participants
n=89 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
|
Race (NIH/OMB)
Primary Caregiver Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
0 Participants
n=50 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
0 Participants
n=89 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
|
Race (NIH/OMB)
Primary Caregiver Race · Black or African American
|
12 Participants
n=39 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
9 Participants
n=50 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
21 Participants
n=89 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
|
Race (NIH/OMB)
Primary Caregiver Race · White
|
22 Participants
n=39 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
34 Participants
n=50 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
56 Participants
n=89 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
|
Race (NIH/OMB)
Primary Caregiver Race · More than one race
|
3 Participants
n=39 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
2 Participants
n=50 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
5 Participants
n=89 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
|
Race (NIH/OMB)
Primary Caregiver Race · Unknown or Not Reported
|
0 Participants
n=39 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
5 Participants
n=50 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
5 Participants
n=89 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
|
Race/Ethnicity, Customized
Child Ethnicity · Hispanic/Latinx
|
21 Participants
n=39 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
35 Participants
n=50 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
56 Participants
n=89 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
|
Race/Ethnicity, Customized
Child Ethnicity · Haitian
|
1 Participants
n=39 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
3 Participants
n=50 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
4 Participants
n=89 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
|
Race/Ethnicity, Customized
Child Ethnicity · Non-Hispanic or Haitian
|
17 Participants
n=39 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
12 Participants
n=50 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
29 Participants
n=89 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
|
Race/Ethnicity, Customized
Primary Caregiver Ethnicity · Hispanic/Latinx
|
20 Participants
n=39 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
36 Participants
n=50 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
56 Participants
n=89 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
|
Race/Ethnicity, Customized
Primary Caregiver Ethnicity · Haitian
|
2 Participants
n=39 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
2 Participants
n=50 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
4 Participants
n=89 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
|
Race/Ethnicity, Customized
Primary Caregiver Ethnicity · Non-Hispanic or Haitian
|
17 Participants
n=39 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
12 Participants
n=50 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
29 Participants
n=89 Participants • Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children)
|
|
Income to needs ratio
|
2.2 ratio
STANDARD_DEVIATION 2.8 • n=39 Participants • The income to needs ratio is reported for each caregiver/child dyad (n=89), not individually for the child and the caregiver.
|
2.6 ratio
STANDARD_DEVIATION 4.01 • n=50 Participants • The income to needs ratio is reported for each caregiver/child dyad (n=89), not individually for the child and the caregiver.
|
2.4 ratio
STANDARD_DEVIATION 3.5 • n=89 Participants • The income to needs ratio is reported for each caregiver/child dyad (n=89), not individually for the child and the caregiver.
|
|
Caregiver Education
< High School
|
4 Participants
n=39 Participants • Caregiver education is reported only for the caregiver (total N=89), not individually for the child and the caregiver. CA+CFI=39 caregivers CA only=50 caregivers
|
10 Participants
n=50 Participants • Caregiver education is reported only for the caregiver (total N=89), not individually for the child and the caregiver. CA+CFI=39 caregivers CA only=50 caregivers
|
14 Participants
n=89 Participants • Caregiver education is reported only for the caregiver (total N=89), not individually for the child and the caregiver. CA+CFI=39 caregivers CA only=50 caregivers
|
|
Caregiver Education
High School/GED
|
12 Participants
n=39 Participants • Caregiver education is reported only for the caregiver (total N=89), not individually for the child and the caregiver. CA+CFI=39 caregivers CA only=50 caregivers
|
15 Participants
n=50 Participants • Caregiver education is reported only for the caregiver (total N=89), not individually for the child and the caregiver. CA+CFI=39 caregivers CA only=50 caregivers
|
27 Participants
n=89 Participants • Caregiver education is reported only for the caregiver (total N=89), not individually for the child and the caregiver. CA+CFI=39 caregivers CA only=50 caregivers
|
|
Caregiver Education
Some College/AA
|
8 Participants
n=39 Participants • Caregiver education is reported only for the caregiver (total N=89), not individually for the child and the caregiver. CA+CFI=39 caregivers CA only=50 caregivers
|
9 Participants
n=50 Participants • Caregiver education is reported only for the caregiver (total N=89), not individually for the child and the caregiver. CA+CFI=39 caregivers CA only=50 caregivers
|
17 Participants
n=89 Participants • Caregiver education is reported only for the caregiver (total N=89), not individually for the child and the caregiver. CA+CFI=39 caregivers CA only=50 caregivers
|
|
Caregiver Education
Bachelor's Degree
|
8 Participants
n=39 Participants • Caregiver education is reported only for the caregiver (total N=89), not individually for the child and the caregiver. CA+CFI=39 caregivers CA only=50 caregivers
|
9 Participants
n=50 Participants • Caregiver education is reported only for the caregiver (total N=89), not individually for the child and the caregiver. CA+CFI=39 caregivers CA only=50 caregivers
|
17 Participants
n=89 Participants • Caregiver education is reported only for the caregiver (total N=89), not individually for the child and the caregiver. CA+CFI=39 caregivers CA only=50 caregivers
|
|
Caregiver Education
Graduate Degree
|
7 Participants
n=39 Participants • Caregiver education is reported only for the caregiver (total N=89), not individually for the child and the caregiver. CA+CFI=39 caregivers CA only=50 caregivers
|
7 Participants
n=50 Participants • Caregiver education is reported only for the caregiver (total N=89), not individually for the child and the caregiver. CA+CFI=39 caregivers CA only=50 caregivers
|
14 Participants
n=89 Participants • Caregiver education is reported only for the caregiver (total N=89), not individually for the child and the caregiver. CA+CFI=39 caregivers CA only=50 caregivers
|
|
Everyday Stressors Index
|
32.6 scores on a scale
STANDARD_DEVIATION 6.9 • n=39 Participants • Everyday Stressors Index is reported for each caregiver/child dyad (total N=89), not individually for the child and the caregiver. CA+CFI = 39 caregiver/child dyad CA only = 50 caregiver/child dyad
|
34.7 scores on a scale
STANDARD_DEVIATION 9.3 • n=50 Participants • Everyday Stressors Index is reported for each caregiver/child dyad (total N=89), not individually for the child and the caregiver. CA+CFI = 39 caregiver/child dyad CA only = 50 caregiver/child dyad
|
33.8 scores on a scale
STANDARD_DEVIATION 8.4 • n=89 Participants • Everyday Stressors Index is reported for each caregiver/child dyad (total N=89), not individually for the child and the caregiver. CA+CFI = 39 caregiver/child dyad CA only = 50 caregiver/child dyad
|
|
Eyberg Child Behavior Inventory
|
157.1 units on a scale
STANDARD_DEVIATION 34.2 • n=39 Participants • Eyeberg Child Behavior Inventory is reported for each caregiver/child dyad (total N=89), not individually for the child and the caregiver. CA+CFI = 39 caregiver/child dyad CA only = 50 caregiver/child dyad
|
149.2 units on a scale
STANDARD_DEVIATION 27.2 • n=50 Participants • Eyeberg Child Behavior Inventory is reported for each caregiver/child dyad (total N=89), not individually for the child and the caregiver. CA+CFI = 39 caregiver/child dyad CA only = 50 caregiver/child dyad
|
152.9 units on a scale
STANDARD_DEVIATION 30.7 • n=89 Participants • Eyeberg Child Behavior Inventory is reported for each caregiver/child dyad (total N=89), not individually for the child and the caregiver. CA+CFI = 39 caregiver/child dyad CA only = 50 caregiver/child dyad
|
PRIMARY outcome
Timeframe: Post Intake Assessment (Week 0)Population: Descriptive analyses were conducted to assess clinical utility.
The CFI Clinician Questionnaire is a 4-item measure developed designed to assess clinical utility of the CFI. Items are rated on a 5-point Likert style scale ranging from 1='not at all' to 5='very much'. Each item has a minimum score of 1 and a max of 5. Items include the extent to which conducting the CFI influences content and quality of information obtained in the intake, realtionship with the caregiver, treatment planning, and differential diagnosis. Higher scores indicate higher levels of clinical utility of the CFI. The measure was given only to the CA + CFI condition. This analysis was utilized to assess for initial utility of the CFI and was mistakenly entered into the system as a primary outcome variable. This measure is not used to determine the effect of an experimental variable on participants in the study. Statistical analyses for this measure were descriptive and only examined for the experimental group.
Outcome measures
| Measure |
Clinical Assessment and CFI
n=39 Participants
CA and CFI families will receive the Cultural Formulation Interview prior to their standard Clinical Assessment during their intake.
Clinical Assessment and CFI: CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.
|
Clinical Assessment Only
CA families will receive a standard Clinical Assessment during intake.
Clinical Assessment: CA families will participate their standard intake procedures.
|
|---|---|---|
|
CFI Clinician Questionnaire
Quality of Information Received
|
4.2 units on a scale
Standard Deviation .59
|
—
|
|
CFI Clinician Questionnaire
Relationship with Caregiver
|
4.1 units on a scale
Standard Deviation .92
|
—
|
|
CFI Clinician Questionnaire
Treatment Planning
|
3.8 units on a scale
Standard Deviation .89
|
—
|
|
CFI Clinician Questionnaire
Differential Diagnosis
|
3.6 units on a scale
Standard Deviation 1
|
—
|
PRIMARY outcome
Timeframe: Post Intake Assessment (Week 0)Population: Linear regressions tested condition effects on caregiver and provider satisfaction, and the extent to which the provider understood the caregivers' values or what is important to them.
The Satisfaction with Intake Questionnaire is a 7-item measure developed for use in the current study to assess parent and clinician satisfaction with their intake assessment. This measure assesses how well the patient/clinician felt the clinician understood the family's problems, cultural background, how their culture may influence their problem, and how much the parent trusts the clinician. Items are rated on a 5-point Likert style scale ranging from 1='not at all' to 5='very much', with higher scores representing higher satisfaction. Each item has a minimum of 1 and maximum of 5. Items were not summed. Two items were analyzed separately for the main outcomes: linear regressions tested condition effects on caregiver and provider satisfaction, and the extent to which the provider understood the caregivers' values or what is important to them.
Outcome measures
| Measure |
Clinical Assessment and CFI
n=39 Participants
CA and CFI families will receive the Cultural Formulation Interview prior to their standard Clinical Assessment during their intake.
Clinical Assessment and CFI: CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.
|
Clinical Assessment Only
n=50 Participants
CA families will receive a standard Clinical Assessment during intake.
Clinical Assessment: CA families will participate their standard intake procedures.
|
|---|---|---|
|
Satisfaction With Intake Questionnaire
Caregiver Post-Assessment Perceptions and Satisfaction: Provider understands family values
|
4.48 units on a scale
Standard Deviation .93
|
4.32 units on a scale
Standard Deviation .88
|
|
Satisfaction With Intake Questionnaire
Caregiver Post-Assessment Perceptions and Satisfaction: Overall Satisfaction
|
4.61 units on a scale
Standard Deviation .93
|
4.7 units on a scale
Standard Deviation .75
|
|
Satisfaction With Intake Questionnaire
Provider Post-Assessment Perceptions and Satisfaction: Understands family values
|
4.57 units on a scale
Standard Deviation .99
|
4.12 units on a scale
Standard Deviation .73
|
|
Satisfaction With Intake Questionnaire
Provider Post-Assessment Perceptions and Satisfaction: Overall Satisfaction
|
4.66 units on a scale
Standard Deviation .7
|
4.52 units on a scale
Standard Deviation .71
|
PRIMARY outcome
Timeframe: Post Intake Assessment (Week 0)Population: Descriptive analyses were conducted to assess clinician fidelity to the CFI and potential cross contamination given therapists delivered both conditions. The percentage was calculated by dividing the number of adherent items by number of CFI items (16 items). This was averaged to come up with the overall adherence value by group.
The CFI Fidelity Instrument assesses fidelity to the CFI (i.e. adherence and competence) in the CA+CFI group and potential cross-condition contamination in CA condition. Independent evaluators masked to condition, study design, and study hypotheses coded recordings of all assessments. This analysis was utilized to assess for feasibility of the pilot study and was mistakenly entered into the system as a primary outcome variable. This measure is not used to determine the effect of an experimental variable on participants in the study. Statistical analyses for this measure were only descriptive.
Outcome measures
| Measure |
Clinical Assessment and CFI
n=39 Participants
CA and CFI families will receive the Cultural Formulation Interview prior to their standard Clinical Assessment during their intake.
Clinical Assessment and CFI: CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.
|
Clinical Assessment Only
n=50 Participants
CA families will receive a standard Clinical Assessment during intake.
Clinical Assessment: CA families will participate their standard intake procedures.
|
|---|---|---|
|
CFI Fidelity Instrument
|
84.4 percentage of adherence to CFI
Standard Deviation 21.5
|
4.8 percentage of adherence to CFI
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: Post Treatment (Anticipated average: Week 14)The WAI-Short Form Revised (WAI-SR; Hatcher \& Gillaspy, 2006) is a 12-item clinician- and patient-report measure of therapeutic alliance that assesses (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Items are rated on a 5-point Likert style scale ranging from 1='never' to 5='always'. Scores on each sub scale are summed to create a total score. Total scores range from 12-60 with higher scores representing higher therapeutic alliance.
Outcome measures
| Measure |
Clinical Assessment and CFI
n=39 Participants
CA and CFI families will receive the Cultural Formulation Interview prior to their standard Clinical Assessment during their intake.
Clinical Assessment and CFI: CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.
|
Clinical Assessment Only
n=50 Participants
CA families will receive a standard Clinical Assessment during intake.
Clinical Assessment: CA families will participate their standard intake procedures.
|
|---|---|---|
|
Working Alliance Inventory-Short Form Revised
|
54.03 score on a scale
Standard Deviation 8.9
|
57.06 score on a scale
Standard Deviation 7.21
|
SECONDARY outcome
Timeframe: Change from Baseline (Week 0) through post treatment (anticipated average: Week 14)Population: Treatment response is a dichotomous variable the data presented below is probability for those variables.
Treatment response reflected traditional PCIT graduation criteria: caregiver skill acquisition as coded against specific criteria in both phases of treatment; and (b) child behavior problems dropped into the subclinical range. Families were classified as Treatment Responders in accordance with formal PCIT graduation criteria, that is: (a) caregivers demonstrated skill acquisition, as coded against specific criteria in both phases of treatment; and (b) child behavior problems dropped into the subclinical range - i.e., Eyberg Child Behavior Inventory (ECBI) falls below 114). Participants were coded as either treatment responders=1, or treatment non-responders=0.
Outcome measures
| Measure |
Clinical Assessment and CFI
n=39 Participants
CA and CFI families will receive the Cultural Formulation Interview prior to their standard Clinical Assessment during their intake.
Clinical Assessment and CFI: CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.
|
Clinical Assessment Only
n=50 Participants
CA families will receive a standard Clinical Assessment during intake.
Clinical Assessment: CA families will participate their standard intake procedures.
|
|---|---|---|
|
Treatment Response
|
.53 probability treatment response
|
.35 probability treatment response
|
SECONDARY outcome
Timeframe: Change from Baseline (Week 0) through post treatmentPopulation: Initial session completion, and completion of first treatment modules are dichotomous variables the data presented below is probability for those variables.
Engagement will be measured for each family via: (a) dichotomous coding of initial session attendance (yes=1, no=0), (b) dichotomous coding of whether they completed the first treatment module (yes=1, no=0), (c) attendance rate (number of sessions attended over number of weeks in treatment), and (d) mean weekly homework completion across treatment (Homework Compliance)
Outcome measures
| Measure |
Clinical Assessment and CFI
n=39 Participants
CA and CFI families will receive the Cultural Formulation Interview prior to their standard Clinical Assessment during their intake.
Clinical Assessment and CFI: CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.
|
Clinical Assessment Only
n=50 Participants
CA families will receive a standard Clinical Assessment during intake.
Clinical Assessment: CA families will participate their standard intake procedures.
|
|---|---|---|
|
Engagement
Session Attendance
|
.65 probability of engagement
|
.57 probability of engagement
|
|
Engagement
Homework Completion
|
.49 probability of engagement
|
.46 probability of engagement
|
|
Engagement
Initial Session Attendance
|
.95 probability of engagement
|
.91 probability of engagement
|
|
Engagement
Completion of first treatment modules
|
.75 probability of engagement
|
.35 probability of engagement
|
SECONDARY outcome
Timeframe: Post Treatment (anticipated average: Week 14)The Therapy Attitudes Inventory (TAI; Brestan et al., 2000) is a 10-item parent-report of satisfaction with treatment including change in child behavior problems and parenting skills on a likert style scale from 1="nothing"-5="very many useful techniques". Items are summed to create a total score. Minimum value is 10 and maximum value is 50. Higher scores represent higher satisfaction with treatment.
Outcome measures
| Measure |
Clinical Assessment and CFI
n=39 Participants
CA and CFI families will receive the Cultural Formulation Interview prior to their standard Clinical Assessment during their intake.
Clinical Assessment and CFI: CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.
|
Clinical Assessment Only
n=50 Participants
CA families will receive a standard Clinical Assessment during intake.
Clinical Assessment: CA families will participate their standard intake procedures.
|
|---|---|---|
|
Therapy Attitudes Inventory
|
48.490 score on a scale
Standard Deviation 3.63
|
48.581 score on a scale
Standard Deviation 2.58
|
SECONDARY outcome
Timeframe: Change from Baseline (Week 0) through post treatment (anticipated average: Week 14)The Eyberg Child Behavior Inventory (ECBI; Eyberg \& Pincus, 1999) is a 36-item parent-report measure of disruptive behavior problems in children as young as 2 years that has shown strong psychometrics. The intensity score is summed to form a total score and ranges from 36 to 252 with higher numbers representing more severe behavior problems. The difference in ECBI score between baseline and treatment completion was measured.
Outcome measures
| Measure |
Clinical Assessment and CFI
n=39 Participants
CA and CFI families will receive the Cultural Formulation Interview prior to their standard Clinical Assessment during their intake.
Clinical Assessment and CFI: CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.
|
Clinical Assessment Only
n=50 Participants
CA families will receive a standard Clinical Assessment during intake.
Clinical Assessment: CA families will participate their standard intake procedures.
|
|---|---|---|
|
Eyberg Child Behavior Inventory
|
46.35 units on a scale
Standard Deviation 42.67
|
51.737 units on a scale
Standard Deviation 39.47
|
SECONDARY outcome
Timeframe: Post Intake Assessment (Week 0)Population: This is a single time point assessment and is therefore not an outcome variable. There was an error when registering in clinical trials. Only baseline descriptive data is provided.
The Everyday Stressors Index (ESI Hall, 1983) is a 20-item measure that assesses daily stressors experienced by economically disadvantaged parents with young children. Items are rated on a Likert-style scale ranging from 1='not at bothered' to 4='bothered a great deal' with higher scores indicating higher levels of stress. The minimum value=20, and maximum value=80 This is a single time point assessment and is therefore not an outcome variable. There was an error when registering in clinical trials.
Outcome measures
| Measure |
Clinical Assessment and CFI
n=39 Participants
CA and CFI families will receive the Cultural Formulation Interview prior to their standard Clinical Assessment during their intake.
Clinical Assessment and CFI: CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.
|
Clinical Assessment Only
n=50 Participants
CA families will receive a standard Clinical Assessment during intake.
Clinical Assessment: CA families will participate their standard intake procedures.
|
|---|---|---|
|
Everyday Stressors Index
|
32.6 score on a scale
Standard Deviation 6.9
|
34.7 score on a scale
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: Post Intake Assessment (Week 0)Population: This is a single time point assessment and is therefore not an outcome variable. There was an error when registering in clinical trials.
The Multigroup Ethnic Identity Measure- Revised (MEIM-R; Phinney \& Ong, 2007) is a 6-item measure that assesses exploration of and commitment to one's ethnic group. Items are rated on a 5-point Likert-style scale from 1='strongly disagree' to 6='strongly agree', with higher scores indicating stronger ethnic identity. This is a single time point assessment and is therefore not an outcome variable. There was an error when registering in clinical trials.
Outcome measures
| Measure |
Clinical Assessment and CFI
n=39 Participants
CA and CFI families will receive the Cultural Formulation Interview prior to their standard Clinical Assessment during their intake.
Clinical Assessment and CFI: CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.
|
Clinical Assessment Only
n=50 Participants
CA families will receive a standard Clinical Assessment during intake.
Clinical Assessment: CA families will participate their standard intake procedures.
|
|---|---|---|
|
Multigroup Ethnic Identity Measure- Revised
|
2.729 score on a scale
Standard Deviation 1.667
|
2.778 score on a scale
Standard Deviation .838
|
SECONDARY outcome
Timeframe: Post Intake Assessment (Week 0)Population: This is a single time point assessment and is therefore not an outcome variable. There was an error when registering in clinical trials.
Two subscales of the Parental Attitudes Toward Psychological Services Inventory (PATPSI; Turner, 2012) will be administered: help seeking attitudes scale (8 items) and the stigmatization scale (8 items) comprising 16 items total. The PATPSI assesses caregivers' attitudes toward outpatient mental health services. Items are rated on a 5-point Likert-style scale from 0='strongly disagree' to 5='strongly agree'. Item responses are summed to form a stigma total scale (minimum value=0 and maximum value=40) and a help seeking total scale (minimum value=0 and maximum value=40) with higher scores representing more mental health related stigma and more positive attitudes toward mental health services. This is a single time point assessment and is therefore not an outcome variable. There was an error when registering in clinical trials.
Outcome measures
| Measure |
Clinical Assessment and CFI
n=39 Participants
CA and CFI families will receive the Cultural Formulation Interview prior to their standard Clinical Assessment during their intake.
Clinical Assessment and CFI: CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.
|
Clinical Assessment Only
n=50 Participants
CA families will receive a standard Clinical Assessment during intake.
Clinical Assessment: CA families will participate their standard intake procedures.
|
|---|---|---|
|
Parental Attitudes Toward Psychological Services Inventory
Stigma Subscale
|
5.847 score on a scale
Standard Deviation 5.19
|
6.172 score on a scale
Standard Deviation 5.57
|
|
Parental Attitudes Toward Psychological Services Inventory
Help Seeking Subscale
|
6.384 score on a scale
Standard Deviation 5.718
|
6.970 score on a scale
Standard Deviation 6.097
|
SECONDARY outcome
Timeframe: Post Intake Assessment (Week 0)Population: This is a single time point assessment and is therefore not an outcome variable. There was an error when registering in clinical trials. Online baseline data is provided.
The Everyday Discrimination Scale (EDS; Williams et al., 1997) is a 9-item measure that assesses aspects of interpersonal discrimination or unfair treatment in their day-to-day life. Items are rated on a Likert-style scale ranging from 0='never' to 5='almost every day', with higher scores indicating more experiences of discrimination. The minimum score is 0 and maximum score is 45. Scores were averaged to create a mean discrimination score which could range from 0 to 5. This is a single time point assessment and is therefore not an outcome variable. There was an error when registering in clinical trials.
Outcome measures
| Measure |
Clinical Assessment and CFI
n=39 Participants
CA and CFI families will receive the Cultural Formulation Interview prior to their standard Clinical Assessment during their intake.
Clinical Assessment and CFI: CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.
|
Clinical Assessment Only
n=50 Participants
CA families will receive a standard Clinical Assessment during intake.
Clinical Assessment: CA families will participate their standard intake procedures.
|
|---|---|---|
|
Everyday Discrimination Scale
|
.806 score on a scale
Standard Deviation .746
|
.658 score on a scale
Standard Deviation .627
|
Adverse Events
Clinical Assessment and CFI
Clinical Assessment Only
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