Improving Satisfaction, Engagement and Outcomes Among Traditionally Underserved Children Through Cultural Formulation
Primary Purpose
Disruptive Behavior
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical Assessment and CFI
Clinical Assessment
Sponsored by
About this trial
This is an interventional other trial for Disruptive Behavior focused on measuring Cultural assessment, Engagement, Diverse Populations
Eligibility Criteria
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
Sites / Locations
- University of Miami Mailman Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Clinical Assessment and CFI
Clinical Assessment Only
Arm Description
CA and CFI families will receive the Cultural Formulation Interview prior to their standard Clinical Assessment during their intake.
CA families will receive a standard Clinical Assessment during intake.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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)
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03499600
First Posted
April 9, 2018
Last Updated
April 5, 2023
Sponsor
Florida International University
Collaborators
University of Miami, National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT03499600
Brief Title
Improving Satisfaction, Engagement and Outcomes Among Traditionally Underserved Children Through Cultural Formulation
Official Title
Improving Satisfaction, Engagement and Clinical Outcomes Among Traditionally Underserved Children Through Cultural Formulation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
October 20, 2018 (Actual)
Study Completion Date
May 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida International University
Collaborators
University of Miami, National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disruptive Behavior
Keywords
Cultural assessment, Engagement, Diverse Populations
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clinical Assessment and CFI
Arm Type
Experimental
Arm Description
CA and CFI families will receive the Cultural Formulation Interview prior to their standard Clinical Assessment during their intake.
Arm Title
Clinical Assessment Only
Arm Type
Active Comparator
Arm Description
CA families will receive a standard Clinical Assessment during intake.
Intervention Type
Behavioral
Intervention Name(s)
Clinical Assessment and CFI
Intervention Description
CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.
Intervention Type
Behavioral
Intervention Name(s)
Clinical Assessment
Intervention Description
CA families will participate their standard intake procedures.
Primary Outcome Measure Information:
Title
CFI Clinician Questionnaire
Description
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)
Title
Satisfaction With Intake Questionnaire
Description
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)
Title
CFI Fidelity Instrument
Description
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)
Secondary Outcome Measure Information:
Title
Working Alliance Inventory-Short Form Revised
Description
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)
Title
Treatment Response
Description
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)
Title
Engagement
Description
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
Title
Therapy Attitudes Inventory
Description
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)
Title
Eyberg Child Behavior Inventory
Description
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)
Title
Everyday Stressors Index
Description
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)
Title
Multigroup Ethnic Identity Measure- Revised
Description
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)
Title
Parental Attitudes Toward Psychological Services Inventory
Description
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)
Title
Everyday Discrimination Scale
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Miami Mailman Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
We will use a controlled access approach, using a robust system to review requests and provide secure access to de-identified data
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