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| ID | Type | Description | Link |
|---|---|---|---|
| R36MH116677-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Miami | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical Assessment and CFI | Experimental | CA and CFI families will receive the Cultural Formulation Interview prior to their standard Clinical Assessment during their intake. |
|
| Clinical Assessment Only | Active Comparator | CA families will receive a standard Clinical Assessment during intake. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Assessment and CFI | Behavioral | CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post Intake Assessment (Week 0) |
| 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. | Post Intake Assessment (Week 0) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Mailman Center | Miami | Florida | 33137 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20410723 | Background | Aggarwal NK. Cultural formulations in child and adolescent psychiatry. J Am Acad Child Adolesc Psychiatry. 2010 Apr;49(4):306-9. No abstract available. | |
| 25372242 | Background | Aggarwal NK, Desilva R, Nicasio AV, Boiler M, Lewis-Fernandez R. Does the Cultural Formulation Interview for the fifth revision of the diagnostic and statistical manual of mental disorders (DSM-5) affect medical communication? A qualitative exploratory study from the New York site. Ethn Health. 2015;20(1):1-28. doi: 10.1080/13557858.2013.857762. Epub 2013 Nov 15. |
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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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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.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Clinical Assessment Only | CA families will receive a standard Clinical Assessment during intake. Clinical Assessment: CA families will participate their standard intake procedures. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
CA + CFI group = 39 caregivers and 39 children (39 caregiver/child dyads). CA only group = 50 caregivers and 50 children (50 caregiver/child dyads)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | CA + CFI group = 39 caregivers and 39 children (39 caregiver/child dyads). CA only group = 50 caregivers and 50 children (50 caregiver/child dyads) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Descriptive analyses were conducted to assess clinical utility. | Posted | Mean | Standard Deviation | units on a scale | Post Intake Assessment (Week 0) |
|
Approximately 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amanda Sanchez | George Mason University | 703-993-1354 | asanch49@gmu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2022 | Aug 10, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000066553 | Problem Behavior |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D002652 | Child Behavior |
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| ID | Term |
|---|---|
| C010073 | chemotactic factor inactivator |
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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).
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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.
| Clinical Assessment | Behavioral | CA families will participate their standard intake procedures. |
|
| Post Intake Assessment (Week 0) |
| Post Treatment (Anticipated average: Week 14) |
| 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. | Change from Baseline (Week 0) through post treatment (anticipated average: Week 14) |
| 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) | Change from Baseline (Week 0) through post treatment |
| 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. | Post Treatment (anticipated average: Week 14) |
| 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. | Change from Baseline (Week 0) through post treatment (anticipated average: Week 14) |
| 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. | Post Intake Assessment (Week 0) |
| 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. | Post Intake Assessment (Week 0) |
| 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. | Post Intake Assessment (Week 0) |
| 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. | Post Intake Assessment (Week 0) |
| 25130248 | Background | Aggarwal NK, Glass A, Tirado A, Boiler M, Nicasio A, Alegria M, Wall M, Lewis-Fernandez R. The development of the DSM-5 Cultural Formulation Interview-Fidelity Instrument (CFI-FI): a pilot study. J Health Care Poor Underserved. 2014 Aug;25(3):1397-417. doi: 10.1353/hpu.2014.0132. |
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| Clinical Assessment Only |
CA families will receive a standard Clinical Assessment during intake. Clinical Assessment: CA families will participate their standard intake procedures. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | We only have sex data available for the child, not the caregiver. There are n=39 children in the CA+CFI group and n=50 children in the CA only group. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Total number of participants= 78 for the CA+CFI group (39 caregivers + 39 children); =100 for CA only group (50 caregivers + 50 children) | Count of Participants | Participants |
|
| Income to needs ratio | Incometo-needs (INR) ratios were computed by dividing their total household income by the Federal Poverty Threshold (FPT) based on their family's size in 2018-2019. The ratio reflects household income relative to the poverty threshold, and categorized as "extreme poverty" (INR ≤ .5), "poor" (.5< INR ≤1), "low-income" (1< INR ≤2), "adequate-income" (2< INR ≤4), and "affluent" (INR > 4). | The income to needs ratio is reported for each caregiver/child dyad (n=89), not individually for the child and the caregiver. | Mean | Standard Deviation | ratio |
|
| Caregiver Education | Caregiver education is reported only for the caregiver (total N=89), not individually for the child and the caregiver. CA+CFI=39 caregivers CA only=50 caregivers | Count of Participants | Participants |
|
| Everyday Stressors Index | The Everyday Stressors Index (ESI) is 20-item measure of daily stressors experienced by economically disadvantaged caregivers with young children. Items are rated on a Likert-style scale ranging from 1 = "not at all bothered" to 4 = "bothered a great deal," as well as "I don't know" = 0, and tallied with higher scores indicating greater daily stress (Scores can range from 0-80). | Everyday Stressors Index is reported for each caregiver/child dyad (total N=89), not individually for the child and the caregiver. CA+CFI = 39 caregiver/child dyad CA only = 50 caregiver/child dyad | Mean | Standard Deviation | scores on a scale |
|
| 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 from age 2 to 18. The ECBI contains an Intensity scale that measures the frequency of disruptive behaviors . Parents rate the intensity of their child's behavior on a Likert-style scale from 1 = 'not at all frequently' to 7 = 'very frequently'. Individual Intensity Score items are summed up, with resultant scores ranging from 36 to 252. An ECBI score of 114 is the clinical cutoff for behavior problems. | Eyeberg Child Behavior Inventory is reported for each caregiver/child dyad (total N=89), not individually for the child and the caregiver. CA+CFI = 39 caregiver/child dyad CA only = 50 caregiver/child dyad | Mean | Standard Deviation | units on a scale |
|
| OG000 | 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. |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Post Intake Assessment (Week 0) |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of adherence to CFI | Post Intake Assessment (Week 0) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Post Treatment (Anticipated average: Week 14) |
|
|
|
|
| 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. | Treatment response is a dichotomous variable the data presented below is probability for those variables. | Posted | Number | probability treatment response | Change from Baseline (Week 0) through post treatment (anticipated average: Week 14) |
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|
|
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| 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) | Initial session completion, and completion of first treatment modules are dichotomous variables the data presented below is probability for those variables. | Posted | Number | probability of engagement | Change from Baseline (Week 0) through post treatment |
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|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Post Treatment (anticipated average: Week 14) |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline (Week 0) through post treatment (anticipated average: Week 14) |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Post Intake Assessment (Week 0) |
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|
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| 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. | This is a single time point assessment and is therefore not an outcome variable. There was an error when registering in clinical trials. | Posted | Mean | Standard Deviation | score on a scale | Post Intake Assessment (Week 0) |
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|
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| 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. | This is a single time point assessment and is therefore not an outcome variable. There was an error when registering in clinical trials. | Posted | Mean | Standard Deviation | score on a scale | Post Intake Assessment (Week 0) |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Post Intake Assessment (Week 0) |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | Clinical Assessment Only | CA families will receive a standard Clinical Assessment during intake. Clinical Assessment: CA families will participate their standard intake procedures. | 0 | 50 | 0 | 50 | 0 | 50 |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Non-Hispanic or Haitian |
|
| Haitian |
|
| Non-Hispanic or Haitian |
|
| Some College/AA |
|
| Bachelor's Degree |
|
| Graduate Degree |
|
| Provider Post-Assessment Perceptions and Satisfaction: Understands family values |
|
| Provider Post-Assessment Perceptions and Satisfaction: Overall Satisfaction |
|
| 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. | Regression, Linear | .68 | Superiority | 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. |
| 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. | Regression, Linear | .03 | Superiority | 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. |
| 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. | Regression, Linear | <.05 | Superiority | 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. |
| Tested the moderation effects of language of service reception and condition on therapeutic alliance. | Regression, Linear | .90 | Superiority |
| Testes the effects of the moderation of language of service delivery and condition on treatment response. | Regression, Logistic | <.05 | Superiority |
| Initial Session Attendance |
|
| Completion of first treatment modules |
|
| Analyses tested the moderation of language of service delivery and condition on session attendance. | Regression, Linear | .01 | Superiority |
| 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. | Regression, Linear | .56 | Superiority |
| Analyses tested the moderation effect of language of service delivery and condition on homework completion. | Regression, Linear | <.01 | Superiority |
| 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. | Regression, Logistic | .40 | Superiority |
| Analyses tested the moderation of language of service delivery and condition on initial session attendance. | Regression, Logistic | .01 | Superiority |
| 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. | Regression, Logistic | .03 | Superiority |
| Analyses tested the moderation of language of service delivery and condition on completion of first treatment module. | Regression, Logistic | .03 | Superiority |