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

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ClinicalTrials.gov Identifier: NCT03499600
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : July 30, 2019
Sponsor:
Collaborator:
University of Miami
Information provided by (Responsible Party):
Florida International University

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.

Condition or disease Intervention/treatment Phase
Disruptive Behavior Behavioral: Clinical Assessment and CFI Behavioral: Clinical Assessment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Coders assessing therapist fidelity to the CFI are kept unaware of the condition to which each participant is assigned. Participants will also be unaware of the condition to which they have been assigned.
Primary Purpose: Other
Official Title: Improving Satisfaction, Engagement and Clinical Outcomes Among Traditionally Underserved Children Through Cultural Formulation
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : October 20, 2018
Actual Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: Clinical Assessment and CFI
CA and CFI families will receive the Cultural Formulation Interview prior to their standard Clinical Assessment during their intake.
Behavioral: Clinical Assessment and CFI
CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.

Active Comparator: Clinical Assessment Only
CA families will receive a standard Clinical Assessment during intake.
Behavioral: Clinical Assessment
CA families will participate their standard intake procedures.




Primary Outcome Measures :
  1. CFI Fidelity Instrument [ Time Frame: Post Intake Assessment (Week 0) ]
    The CFI Fidelity Instrument (CFI-FI; Aggarwal et al., 2014) assesses adherence and competence in the CA+CFI group and to ensure that patients in the CA condition are not receiving the CFI.

  2. CFI Clinician Questionnaire [ Time Frame: Post Intake Assessment (Week 0) ]
    The CFI Clinician Questionnaire is a 7-item measure developed designed to assess feasibility, acceptability and 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'.

  3. Satisfaction with Intake Questionnaire [ Time Frame: 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'.


Secondary Outcome Measures :
  1. Cultural Competence Assessment [ Time Frame: Pre Intake Assessment (Week 0) ]
    Two subscales of the Cultural Competence Assessment (CCA; Schim et al., 2003) will be completed: the cultural competence behaviors scale and the cultural awareness and sensitivity scale, comprising 20 items.

  2. Therapy Attitudes Inventory [ Time Frame: 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.

  3. Working Alliance Inventory-Short Form Revised [ Time Frame: 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'.

  4. Eyberg Child Behavior Inventory [ Time Frame: 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 and Problem scales will be used to assess changes in child disruptive behavior.

  5. Everyday Stressors Index [ Time Frame: 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'.

  6. Multigroup Ethnic Identity Measure- Revised [ Time Frame: 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'. T

  7. Parental Attitudes Toward Psychological Services Inventory [ Time Frame: 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 and the stigmatization scale comprising 16 items. 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'.

  8. Parent quickness to mastery criteria [ Time Frame: Change from Baseline (Week 0) through post treatment (anticipated average: Week 14) ]
    Parent quickness to mastery criteria of the parenting skills used in Parent Child Interaction Therapy will be assessed.

  9. Everyday Discrimination Scale [ Time Frame: 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 1='never' to 6='almost every day'.

  10. Engagement [ Time Frame: Change from Baseline (Week 0) through post treatment (anticipated average: Week 14) ]
    Engagement will be measured for each family via: (a) initial session attendance, (b) dichotomous coding of whether they completed their full course of behavioral parent training or whether they dropped out prematurely (Dropout), (c) attendance rate (number of sessions attended over number of weeks in treatment), and (d) mean weekly homework completion across treatment (Homework Compliance)



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Ages Eligible for Study:   2 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499600


Locations
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United States, Florida
University of Miami Mailman Center
Miami, Florida, United States, 33137
Sponsors and Collaborators
Florida International University
University of Miami
Publications:
Alegría, M., Green, J. G., McLaughlin, K. A., & Loder, S. (2015). Disparities in child and adolescent mental health and mental health services in the US.
American Psychiatric Association (2000). Diagnostic and statisticalmanual of mental disorders (4th ed., text rev.). Washington, DC: Author.
American Psychiatric Association (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Arlington, VA: American Psychiatric Publishing.
Eyberg, S. M., & Pincus, D. (1999). ECBI & SESBI-R: Eyberg child behavior inventory and Sutter-Eyberg student behavior inventory-revised: Professional manual. Psychological Assessment Resources
Fantuzzo, J., Stoltzfus, J., Lutz, M. N., Hamlet, H., Balraj, V., Turner, C., & Mosca, S. (1999). An evaluation of the special needs referral process for low-income preschool children with emotional and behavioral problems. Early Childhood Research Quarterly, 14(4), 465-482
Fernandez, M. (2011). Treatment outcome for low socioeconomic status African American families in parent child interaction therapy: A pilot study. Child and Family Behavior Therapy, 33, 32-48.
Hall, LA. Social support, everyday stressors, and maternal mental health (Unpublished doctoral dissertation). Chapel Hill, NC: University of North Carolina; 1983.
Hatcher, R. L., & Gillaspy, J. A. (2006). Development and validation of a revised short version of the Working Alliance Inventory. Psychotherapy Research, 16(1), 12-25.
Herschell, A. D., Calzada, E. J., Eyberg, S. M., & McNeil, C. B. (2002). Parent-child interaction therapy: New directions in research. Cognitive and Behavioral Practice, 9(1), 9-16.
Kazdin, A. E., Mazurick, J. L., & Bass, D. (1993). Risk for attrition in treatment of antisocial children and families. Journal of Clinical Child Psychology, 22(1), 2-16.
Kirmayer, L. J., Rousseau, C., Rosenberg, E., Clarke, H., Saucier, J. F., Sterlin, C., ... & Latimer, E. (2001). Development and evaluation of a cultural consultation service in mental health. Culture and Mental Health Research Unit, Report, 11.
Lau, A. S. (2006). Making the case for selective and directed cultural adaptations of evidence-based treatments: examples from parent training. Clinical psychology: Science and Practice, 13(4), 295-310.
Lewis-Fernández, R., Aggarwal, N. K., Hinton, L., Hinton, D. E., & Kirmayer L. .J., (Eds.). (2015). DSM-5® handbook on the cultural formulation interview. American Psychiatric Association Publishing.
National Institute of Mental Health. Blueprint for change: research on child and adolescent mental health. Rockville: US Department of Health and Human Services Administration, Center of Mental Health Services, National Institute of Health, National Institute of Mental Health; 2001.
Phinney, J. S., & Ong, A. D. (2007). Conceptualization and measurement of ethnic identity: Current status and future directions. Journal of Counseling Psychology, 54(3), 271.
Qi, C. H., & Kaiser, A. P. (2003). Behavior problems of preschool children from low-income families review of the literature. Topics in Early Childhood Special Education, 23(4), 188-216.
Spoth, R., Redmond, C., Hockaday, C., & Shin, C. Y. (1996). Barriers to participation in family skills preventive interventions and their evaluations: A replication and extension. Family Relations, 247-254.

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Responsible Party: Florida International University
ClinicalTrials.gov Identifier: NCT03499600    
Other Study ID Numbers: 106618
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Florida International University:
Cultural assessment
Engagement
Diverse Populations
Additional relevant MeSH terms:
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Problem Behavior
Behavioral Symptoms