Disruptive Behavior
Conditions
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
CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.
CA families will participate their standard intake procedures.
Sponsors
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| CFI Clinician Questionnaire | Post 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 Questionnaire | Post 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 Instrument | Post 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
| Measure | Time frame | Description |
|---|---|---|
| Therapy Attitudes Inventory | 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. |
| Eyberg Child Behavior Inventory | 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. |
| Everyday Stressors Index | Post 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 Revised | 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. |
| Parental Attitudes Toward Psychological Services Inventory | Post 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 Scale | Post 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- Revised | Post 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 Response | Change 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. |
| Engagement | Change from Baseline (Week 0) through post treatment | 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) |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 178 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Caregiver/child dyad dropped out before completing a full course of treatment | 21 | 30 |
Baseline characteristics
| Characteristic | Clinical Assessment and CFI | Total | Clinical 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 Participants | 17 Participants | 9 Participants |
| Caregiver Education Graduate Degree | 7 Participants | 14 Participants | 7 Participants |
| Caregiver Education < High School | 4 Participants | 14 Participants | 10 Participants |
| Caregiver Education High School/GED | 12 Participants | 27 Participants | 15 Participants |
| Caregiver Education Some College/AA | 8 Participants | 17 Participants | 9 Participants |
| Everyday Stressors Index | 32.6 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 Inventory | 157.1 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 ratio | 2.2 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 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Child Ethnicity Hispanic/Latinx | 21 Participants | 56 Participants | 35 Participants |
| Race/Ethnicity, Customized Child Ethnicity Non-Hispanic or Haitian | 17 Participants | 29 Participants | 12 Participants |
| Race/Ethnicity, Customized Primary Caregiver Ethnicity Haitian | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Primary Caregiver Ethnicity Hispanic/Latinx | 20 Participants | 56 Participants | 36 Participants |
| Race/Ethnicity, Customized Primary Caregiver Ethnicity Non-Hispanic or Haitian | 17 Participants | 29 Participants | 12 Participants |
| Race (NIH/OMB) Child Race American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Child Race Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Child Race Black or African American | 11 Participants | 19 Participants | 8 Participants |
| Race (NIH/OMB) Child Race More than one race | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) Child Race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Child Race Unknown or Not Reported | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Child Race White | 22 Participants | 56 Participants | 34 Participants |
| Race (NIH/OMB) Primary Caregiver Race American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Primary Caregiver Race Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Primary Caregiver Race Black or African American | 12 Participants | 21 Participants | 9 Participants |
| Race (NIH/OMB) Primary Caregiver Race More than one race | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Primary Caregiver Race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Primary Caregiver Race Unknown or Not Reported | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) Primary Caregiver Race White | 22 Participants | 56 Participants | 34 Participants |
| Sex: Female, Male Child Sex Female | 11 Participants | 28 Participants | 17 Participants |
| Sex: Female, Male Child Sex Male | 28 Participants | 61 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 50 |
| other Total, other adverse events | 0 / 39 | 0 / 50 |
| serious Total, serious adverse events | 0 / 39 | 0 / 50 |
Outcome results
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinical Assessment and CFI | CFI Clinician Questionnaire | Quality of Information Received | 4.2 units on a scale | Standard Deviation 0.59 |
| Clinical Assessment and CFI | CFI Clinician Questionnaire | Relationship with Caregiver | 4.1 units on a scale | Standard Deviation 0.92 |
| Clinical Assessment and CFI | CFI Clinician Questionnaire | Treatment Planning | 3.8 units on a scale | Standard Deviation 0.89 |
| Clinical Assessment and CFI | CFI Clinician Questionnaire | Differential Diagnosis | 3.6 units on a scale | Standard Deviation 1 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Assessment and CFI | CFI Fidelity Instrument | 84.4 percentage of adherence to CFI | Standard Deviation 21.5 |
| Clinical Assessment Only | CFI Fidelity Instrument | 4.8 percentage of adherence to CFI | Standard Deviation 10.5 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinical Assessment and CFI | Satisfaction With Intake Questionnaire | Caregiver Post-Assessment Perceptions and Satisfaction: Provider understands family values | 4.48 units on a scale | Standard Deviation 0.93 |
| Clinical Assessment and CFI | Satisfaction With Intake Questionnaire | Caregiver Post-Assessment Perceptions and Satisfaction: Overall Satisfaction | 4.61 units on a scale | Standard Deviation 0.93 |
| Clinical Assessment and CFI | Satisfaction With Intake Questionnaire | Provider Post-Assessment Perceptions and Satisfaction: Understands family values | 4.57 units on a scale | Standard Deviation 0.99 |
| Clinical Assessment and CFI | Satisfaction With Intake Questionnaire | Provider Post-Assessment Perceptions and Satisfaction: Overall Satisfaction | 4.66 units on a scale | Standard Deviation 0.7 |
| Clinical Assessment Only | Satisfaction With Intake Questionnaire | Provider Post-Assessment Perceptions and Satisfaction: Overall Satisfaction | 4.52 units on a scale | Standard Deviation 0.71 |
| Clinical Assessment Only | Satisfaction With Intake Questionnaire | Caregiver Post-Assessment Perceptions and Satisfaction: Provider understands family values | 4.32 units on a scale | Standard Deviation 0.88 |
| Clinical Assessment Only | Satisfaction With Intake Questionnaire | Provider Post-Assessment Perceptions and Satisfaction: Understands family values | 4.12 units on a scale | Standard Deviation 0.73 |
| Clinical Assessment Only | Satisfaction With Intake Questionnaire | Caregiver Post-Assessment Perceptions and Satisfaction: Overall Satisfaction | 4.7 units on a scale | Standard Deviation 0.75 |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clinical Assessment and CFI | Engagement | Session Attendance | .65 probability of engagement |
| Clinical Assessment and CFI | Engagement | Homework Completion | .49 probability of engagement |
| Clinical Assessment and CFI | Engagement | Initial Session Attendance | .95 probability of engagement |
| Clinical Assessment and CFI | Engagement | Completion of first treatment modules | .75 probability of engagement |
| Clinical Assessment Only | Engagement | Completion of first treatment modules | .35 probability of engagement |
| Clinical Assessment Only | Engagement | Session Attendance | .57 probability of engagement |
| Clinical Assessment Only | Engagement | Initial Session Attendance | .91 probability of engagement |
| Clinical Assessment Only | Engagement | Homework Completion | .46 probability of engagement |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Assessment and CFI | Everyday Discrimination Scale | .806 score on a scale | Standard Deviation 0.746 |
| Clinical Assessment Only | Everyday Discrimination Scale | .658 score on a scale | Standard Deviation 0.627 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Assessment and CFI | Everyday Stressors Index | 32.6 score on a scale | Standard Deviation 6.9 |
| Clinical Assessment Only | Everyday Stressors Index | 34.7 score on a scale | Standard Deviation 9.3 |
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Assessment and CFI | Eyberg Child Behavior Inventory | 46.35 units on a scale | Standard Deviation 42.67 |
| Clinical Assessment Only | Eyberg Child Behavior Inventory | 51.737 units on a scale | Standard Deviation 39.47 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Assessment and CFI | Multigroup Ethnic Identity Measure- Revised | 2.729 score on a scale | Standard Deviation 1.667 |
| Clinical Assessment Only | Multigroup Ethnic Identity Measure- Revised | 2.778 score on a scale | Standard Deviation 0.838 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinical Assessment and CFI | Parental Attitudes Toward Psychological Services Inventory | Stigma Subscale | 5.847 score on a scale | Standard Deviation 5.19 |
| Clinical Assessment and CFI | Parental Attitudes Toward Psychological Services Inventory | Help Seeking Subscale | 6.384 score on a scale | Standard Deviation 5.718 |
| Clinical Assessment Only | Parental Attitudes Toward Psychological Services Inventory | Stigma Subscale | 6.172 score on a scale | Standard Deviation 5.57 |
| Clinical Assessment Only | Parental Attitudes Toward Psychological Services Inventory | Help Seeking Subscale | 6.970 score on a scale | Standard Deviation 6.097 |
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Assessment and CFI | Therapy Attitudes Inventory | 48.490 score on a scale | Standard Deviation 3.63 |
| Clinical Assessment Only | Therapy Attitudes Inventory | 48.581 score on a scale | Standard Deviation 2.58 |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clinical Assessment and CFI | Treatment Response | .53 probability treatment response |
| Clinical Assessment Only | Treatment Response | .35 probability treatment response |
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Assessment and CFI | Working Alliance Inventory-Short Form Revised | 54.03 score on a scale | Standard Deviation 8.9 |
| Clinical Assessment Only | Working Alliance Inventory-Short Form Revised | 57.06 score on a scale | Standard Deviation 7.21 |