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Improving Satisfaction, Engagement and Outcomes Among Traditionally Underserved Children Through Cultural Formulation

Improving Satisfaction, Engagement and Clinical Outcomes Among Traditionally Underserved Children Through Cultural Formulation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03499600
Enrollment
89
Registered
2018-04-17
Start date
2017-08-01
Completion date
2019-05-30
Last updated
2023-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disruptive Behavior

Keywords

Cultural assessment, Engagement, Diverse Populations

Brief summary

The project at the center of this proposal will leverage a pilot randomized design to examine initial feasibility and preliminary effects of augmenting usual mental health evaluation procedures with a structured person-centered assessment tool that specifically considers the cultural context of patient mental health problems (i.e., the Cultural Formulation Interview; CFI) on parent satisfaction, engagement and clinical child outcomes in the treatment of early child behavior problems. Additional analyses will explore whether traditional barriers (e.g., stigma, ethnic identity, and daily stress) moderate the effects of the CFI on satisfaction, engagement and treatment outcomes.

Detailed description

This project is leveraging a pilot randomized design to evaluate initial feasibility and preliminarily examine whether augmenting assessment procedures for child behavior problems with the CFI improves satisfaction with assessment procedures and treatment, parent engagement in subsequent behavior parent training, and ultimately clinical child outcomes. Exploratory analyses will further consider whether traditional barriers to care moderate outcomes. The study is being conducted within a large South Florida mental health network serving predominately low-income minority families obtaining parent training for early child behavior problems. Participating families will be randomized at baseline to receive either the standard diagnostic and clinical assessment (CA) or CA+CFI. Specifically, the investigators are interested in assessing study feasibility. Feasibility of recruitment and randomization, study retention, and condition integrity will be monitored. Additionally, clinician reports of CFI feasibility, acceptability and clinical utility will be examined. An additional main outcome will be initial satisfaction directly after the interview. It is hypothesized that families in the CA+CFI group will report higher levels of initial satisfaction than the CA group. A secondary goal is to assess preliminary effects of administering the CFI on treatment satisfaction, engagement and clinical child outcomes. Parents and therapists will report on their satisfaction with treatment. Engagement outcomes will be measured via: (a) initial session attendance, (b) drop out rate (c) session attendance rate, (d) homework completion rate, and (e) therapeutic alliance. Clinical outcomes will be measured via parent ratings of child behavior problems and parent time to skill mastery. It is hypothesized that CA+CFI families will demonstrate improved satisfaction, engagement and clinical outcomes relative to CA families. Further exploratory analyses will examine individual differences in effects related to traditional barriers to care. Exploratory analyses will examine stigma, ethnic identity, and daily stress as moderators of the effects of CFI administration on satisfaction, engagement and clinical outcomes. It is hypothesized that CFI effects will be particularly strong for families who experience greater traditional barriers to care.

Interventions

BEHAVIORALClinical Assessment and CFI

CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.

BEHAVIORALClinical Assessment

CA families will participate their standard intake procedures.

Sponsors

University of Miami
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
Florida International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Coders assessing therapist fidelity to the CFI are kept unaware of the condition to which each participant is assigned. Participants will also be unaware of the condition to which they have been assigned.

Intervention model description

Randomized control trial in which participants are randomly assigned to either receive a diagnostic and clinical assessment plus the cultural formulation interview (CA and CFI) or the diagnostic and clinical assessment (CA).

Eligibility

Sex/Gender
ALL
Age
2 Years to 7 Years
Healthy volunteers
No

Inclusion criteria

* Child with elevated behavior problems * Child is between ages 2-7 years (inclusive) * Family seeking services at one of the University of Miami PCIT-Community Connect Centers

Exclusion criteria

* Parent is actively abusing illegal substances * Child is younger than 2 years of age * Child is older than 7 years of age

Design outcomes

Primary

MeasureTime frameDescription
CFI Clinician QuestionnairePost Intake Assessment (Week 0)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.
Satisfaction With Intake QuestionnairePost Intake Assessment (Week 0)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.
CFI Fidelity InstrumentPost Intake Assessment (Week 0)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.

Secondary

MeasureTime frameDescription
Therapy Attitudes InventoryPost 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.
Eyberg Child Behavior InventoryChange 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.
Everyday Stressors IndexPost Intake Assessment (Week 0)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.
Working Alliance Inventory-Short Form RevisedPost 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.
Parental Attitudes Toward Psychological Services InventoryPost Intake Assessment (Week 0)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.
Everyday Discrimination ScalePost Intake Assessment (Week 0)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.
Multigroup Ethnic Identity Measure- RevisedPost Intake Assessment (Week 0)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.
Treatment ResponseChange from Baseline (Week 0) through post treatment (anticipated average: Week 14)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.
EngagementChange from Baseline (Week 0) through post treatmentEngagement 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)

Countries

United States

Participant flow

Recruitment details

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).

Pre-assignment details

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.

Participants by arm

ArmCount
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.
78
Clinical Assessment Only
CA families will receive a standard Clinical Assessment during intake. Clinical Assessment: CA families will participate their standard intake procedures.
100
Total178

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyCaregiver/child dyad dropped out before completing a full course of treatment2130

Baseline characteristics

CharacteristicClinical Assessment and CFITotalClinical Assessment Only
Age, Continuous
Caregiver Age
35.1 years
STANDARD_DEVIATION 7.4
34.4 years
STANDARD_DEVIATION 7.2
33.8 years
STANDARD_DEVIATION 70
Age, Continuous
Child Age
5.2 years
STANDARD_DEVIATION 1.6
5.1 years
STANDARD_DEVIATION 1.6
5.03 years
STANDARD_DEVIATION 1.5
Caregiver Education
Bachelor's Degree
8 Participants17 Participants9 Participants
Caregiver Education
Graduate Degree
7 Participants14 Participants7 Participants
Caregiver Education
< High School
4 Participants14 Participants10 Participants
Caregiver Education
High School/GED
12 Participants27 Participants15 Participants
Caregiver Education
Some College/AA
8 Participants17 Participants9 Participants
Everyday Stressors Index32.6 scores on a scale
STANDARD_DEVIATION 6.9
33.8 scores on a scale
STANDARD_DEVIATION 8.4
34.7 scores on a scale
STANDARD_DEVIATION 9.3
Eyberg Child Behavior Inventory157.1 units on a scale
STANDARD_DEVIATION 34.2
152.9 units on a scale
STANDARD_DEVIATION 30.7
149.2 units on a scale
STANDARD_DEVIATION 27.2
Income to needs ratio2.2 ratio
STANDARD_DEVIATION 2.8
2.4 ratio
STANDARD_DEVIATION 3.5
2.6 ratio
STANDARD_DEVIATION 4.01
Race/Ethnicity, Customized
Child Ethnicity
Haitian
1 Participants4 Participants3 Participants
Race/Ethnicity, Customized
Child Ethnicity
Hispanic/Latinx
21 Participants56 Participants35 Participants
Race/Ethnicity, Customized
Child Ethnicity
Non-Hispanic or Haitian
17 Participants29 Participants12 Participants
Race/Ethnicity, Customized
Primary Caregiver Ethnicity
Haitian
2 Participants4 Participants2 Participants
Race/Ethnicity, Customized
Primary Caregiver Ethnicity
Hispanic/Latinx
20 Participants56 Participants36 Participants
Race/Ethnicity, Customized
Primary Caregiver Ethnicity
Non-Hispanic or Haitian
17 Participants29 Participants12 Participants
Race (NIH/OMB)
Child Race
American Indian or Alaska Native
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Child Race
Asian
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Child Race
Black or African American
11 Participants19 Participants8 Participants
Race (NIH/OMB)
Child Race
More than one race
4 Participants8 Participants4 Participants
Race (NIH/OMB)
Child Race
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Child Race
Unknown or Not Reported
0 Participants4 Participants4 Participants
Race (NIH/OMB)
Child Race
White
22 Participants56 Participants34 Participants
Race (NIH/OMB)
Primary Caregiver Race
American Indian or Alaska Native
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Primary Caregiver Race
Asian
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Primary Caregiver Race
Black or African American
12 Participants21 Participants9 Participants
Race (NIH/OMB)
Primary Caregiver Race
More than one race
3 Participants5 Participants2 Participants
Race (NIH/OMB)
Primary Caregiver Race
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Primary Caregiver Race
Unknown or Not Reported
0 Participants5 Participants5 Participants
Race (NIH/OMB)
Primary Caregiver Race
White
22 Participants56 Participants34 Participants
Sex: Female, Male
Child Sex
Female
11 Participants28 Participants17 Participants
Sex: Female, Male
Child Sex
Male
28 Participants61 Participants33 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 390 / 50
other
Total, other adverse events
0 / 390 / 50
serious
Total, serious adverse events
0 / 390 / 50

Outcome results

Primary

CFI Clinician Questionnaire

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.

Time frame: Post Intake Assessment (Week 0)

Population: Descriptive analyses were conducted to assess clinical utility.

ArmMeasureGroupValue (MEAN)Dispersion
Clinical Assessment and CFICFI Clinician QuestionnaireQuality of Information Received4.2 units on a scaleStandard Deviation 0.59
Clinical Assessment and CFICFI Clinician QuestionnaireRelationship with Caregiver4.1 units on a scaleStandard Deviation 0.92
Clinical Assessment and CFICFI Clinician QuestionnaireTreatment Planning3.8 units on a scaleStandard Deviation 0.89
Clinical Assessment and CFICFI Clinician QuestionnaireDifferential Diagnosis3.6 units on a scaleStandard Deviation 1
Primary

CFI Fidelity Instrument

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Clinical Assessment and CFICFI Fidelity Instrument84.4 percentage of adherence to CFIStandard Deviation 21.5
Clinical Assessment OnlyCFI Fidelity Instrument4.8 percentage of adherence to CFIStandard Deviation 10.5
Primary

Satisfaction With Intake Questionnaire

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Clinical Assessment and CFISatisfaction With Intake QuestionnaireCaregiver Post-Assessment Perceptions and Satisfaction: Provider understands family values4.48 units on a scaleStandard Deviation 0.93
Clinical Assessment and CFISatisfaction With Intake QuestionnaireCaregiver Post-Assessment Perceptions and Satisfaction: Overall Satisfaction4.61 units on a scaleStandard Deviation 0.93
Clinical Assessment and CFISatisfaction With Intake QuestionnaireProvider Post-Assessment Perceptions and Satisfaction: Understands family values4.57 units on a scaleStandard Deviation 0.99
Clinical Assessment and CFISatisfaction With Intake QuestionnaireProvider Post-Assessment Perceptions and Satisfaction: Overall Satisfaction4.66 units on a scaleStandard Deviation 0.7
Clinical Assessment OnlySatisfaction With Intake QuestionnaireProvider Post-Assessment Perceptions and Satisfaction: Overall Satisfaction4.52 units on a scaleStandard Deviation 0.71
Clinical Assessment OnlySatisfaction With Intake QuestionnaireCaregiver Post-Assessment Perceptions and Satisfaction: Provider understands family values4.32 units on a scaleStandard Deviation 0.88
Clinical Assessment OnlySatisfaction With Intake QuestionnaireProvider Post-Assessment Perceptions and Satisfaction: Understands family values4.12 units on a scaleStandard Deviation 0.73
Clinical Assessment OnlySatisfaction With Intake QuestionnaireCaregiver Post-Assessment Perceptions and Satisfaction: Overall Satisfaction4.7 units on a scaleStandard Deviation 0.75
Comparison: A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. This linear regressions tested condition effects on caregiver perceptions of the extent to which the provider understood the caregivers' values or what is important to them.p-value: 0.03Regression, Linear
Comparison: A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed.This linear regressions tested condition effects on caregiver satisfaction with the intake.p-value: 0.68Regression, Linear
Comparison: A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed.This linear regressions tested condition effects on provider perceptions of the extent to which the provider understood the caregivers' values or what is important to them.p-value: 0.03Regression, Linear
Comparison: A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. This linear regressions tested condition effects on provider satisfaction with the intake.p-value: <0.05Regression, Linear
Secondary

Engagement

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)

Time frame: Change from Baseline (Week 0) through post treatment

Population: Initial session completion, and completion of first treatment modules are dichotomous variables the data presented below is probability for those variables.

ArmMeasureGroupValue (NUMBER)
Clinical Assessment and CFIEngagementSession Attendance.65 probability of engagement
Clinical Assessment and CFIEngagementHomework Completion.49 probability of engagement
Clinical Assessment and CFIEngagementInitial Session Attendance.95 probability of engagement
Clinical Assessment and CFIEngagementCompletion of first treatment modules.75 probability of engagement
Clinical Assessment OnlyEngagementCompletion of first treatment modules.35 probability of engagement
Clinical Assessment OnlyEngagementSession Attendance.57 probability of engagement
Clinical Assessment OnlyEngagementInitial Session Attendance.91 probability of engagement
Clinical Assessment OnlyEngagementHomework Completion.46 probability of engagement
Comparison: A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. Linear regressions tested condition effects on session attendance.p-value: 0.38Regression, Linear
Comparison: Analyses tested the moderation of language of service delivery and condition on session attendance.p-value: 0.01Regression, Linear
Comparison: Power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. linear regressions tested condition effects on homework completion. Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.p-value: 0.56Regression, Linear
Comparison: Analyses tested the moderation effect of language of service delivery and condition on homework completion.p-value: <0.01Regression, Linear
Comparison: Power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. Logistic regressions tested condition effects on initial session attendance. Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.p-value: 0.4Regression, Logistic
Comparison: Analyses tested the moderation of language of service delivery and condition on initial session attendance.p-value: 0.01Regression, Logistic
Comparison: power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. A Logistic regression tested condition effects on completion of first treatment module. Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.p-value: 0.03Regression, Logistic
Comparison: Analyses tested the moderation of language of service delivery and condition on completion of first treatment module.p-value: 0.03Regression, Logistic
Secondary

Everyday Discrimination Scale

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Clinical Assessment and CFIEveryday Discrimination Scale.806 score on a scaleStandard Deviation 0.746
Clinical Assessment OnlyEveryday Discrimination Scale.658 score on a scaleStandard Deviation 0.627
Secondary

Everyday Stressors Index

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Clinical Assessment and CFIEveryday Stressors Index32.6 score on a scaleStandard Deviation 6.9
Clinical Assessment OnlyEveryday Stressors Index34.7 score on a scaleStandard Deviation 9.3
Secondary

Eyberg Child Behavior Inventory

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.

Time frame: Change from Baseline (Week 0) through post treatment (anticipated average: Week 14)

ArmMeasureValue (MEAN)Dispersion
Clinical Assessment and CFIEyberg Child Behavior Inventory46.35 units on a scaleStandard Deviation 42.67
Clinical Assessment OnlyEyberg Child Behavior Inventory51.737 units on a scaleStandard Deviation 39.47
Comparison: A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. linear regressions tested change in ECBI score from baseline to post treatment.p-value: 0.319Regression, Linear
Secondary

Multigroup Ethnic Identity Measure- Revised

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Clinical Assessment and CFIMultigroup Ethnic Identity Measure- Revised2.729 score on a scaleStandard Deviation 1.667
Clinical Assessment OnlyMultigroup Ethnic Identity Measure- Revised2.778 score on a scaleStandard Deviation 0.838
Secondary

Parental Attitudes Toward Psychological Services Inventory

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Clinical Assessment and CFIParental Attitudes Toward Psychological Services InventoryStigma Subscale5.847 score on a scaleStandard Deviation 5.19
Clinical Assessment and CFIParental Attitudes Toward Psychological Services InventoryHelp Seeking Subscale6.384 score on a scaleStandard Deviation 5.718
Clinical Assessment OnlyParental Attitudes Toward Psychological Services InventoryStigma Subscale6.172 score on a scaleStandard Deviation 5.57
Clinical Assessment OnlyParental Attitudes Toward Psychological Services InventoryHelp Seeking Subscale6.970 score on a scaleStandard Deviation 6.097
Secondary

Therapy Attitudes Inventory

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.

Time frame: Post Treatment (anticipated average: Week 14)

ArmMeasureValue (MEAN)Dispersion
Clinical Assessment and CFITherapy Attitudes Inventory48.490 score on a scaleStandard Deviation 3.63
Clinical Assessment OnlyTherapy Attitudes Inventory48.581 score on a scaleStandard Deviation 2.58
Comparison: A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. linear regressions tested condition effects on treatment satisfaction.p-value: 0.854Regression, Linear
Secondary

Treatment Response

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.

Time frame: 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.

ArmMeasureValue (NUMBER)
Clinical Assessment and CFITreatment Response.53 probability treatment response
Clinical Assessment OnlyTreatment Response.35 probability treatment response
Comparison: A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. A logistic regression tested condition effects on treatment response.p-value: 0.171Regression, Logistic
Comparison: Testes the effects of the moderation of language of service delivery and condition on treatment response.p-value: <0.05Regression, Logistic
Secondary

Working Alliance Inventory-Short Form Revised

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.

Time frame: Post Treatment (Anticipated average: Week 14)

ArmMeasureValue (MEAN)Dispersion
Clinical Assessment and CFIWorking Alliance Inventory-Short Form Revised54.03 score on a scaleStandard Deviation 8.9
Clinical Assessment OnlyWorking Alliance Inventory-Short Form Revised57.06 score on a scaleStandard Deviation 7.21
Comparison: Power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. Linear regressions tested condition effects on therapeutic alliance.p-value: 0.93Regression, Linear
Comparison: Tested the moderation effects of language of service reception and condition on therapeutic alliance.p-value: 0.9Regression, Linear

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026