Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03499600
Other study ID # 106618
Secondary ID R36MH116677-01
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2017
Est. completion date May 30, 2019

Study information

Verified date April 2023
Source Florida International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date May 30, 2019
Est. primary completion date October 20, 2018
Accepts healthy volunteers No
Gender All
Age group 2 Years to 7 Years
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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Clinical Assessment and CFI
CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.
Clinical Assessment
CA families will participate their standard intake procedures.

Locations

Country Name City State
United States University of Miami Mailman Center Miami Florida

Sponsors (3)

Lead Sponsor Collaborator
Florida International University National Institute of Mental Health (NIMH), University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (77)

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. — View Citation

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. — View Citation

Aggarwal NK, Lam P, Castillo EG, Weiss MG, Diaz E, Alarcon RD, van Dijk R, Rohlof H, Ndetei DM, Scalco M, Aguilar-Gaxiola S, Bassiri K, Deshpande S, Groen S, Jadhav S, Kirmayer LJ, Paralikar V, Westermeyer J, Santos F, Vega-Dienstmaier J, Anez L, Boiler M, Nicasio AV, Lewis-Fernandez R. How Do Clinicians Prefer Cultural Competence Training? Findings from the DSM-5 Cultural Formulation Interview Field Trial. Acad Psychiatry. 2016 Aug;40(4):584-91. doi: 10.1007/s40596-015-0429-3. Epub 2015 Oct 8. — View Citation

Aggarwal NK, Nicasio AV, DeSilva R, Boiler M, Lewis-Fernandez R. Barriers to implementing the DSM-5 cultural formulation interview: a qualitative study. Cult Med Psychiatry. 2013 Sep;37(3):505-33. doi: 10.1007/s11013-013-9325-z. — View Citation

Aggarwal NK. Cultural formulations in child and adolescent psychiatry. J Am Acad Child Adolesc Psychiatry. 2010 Apr;49(4):306-9. No abstract available. — View Citation

Akincigil A, Olfson M, Siegel M, Zurlo KA, Walkup JT, Crystal S. Racial and ethnic disparities in depression care in community-dwelling elderly in the United States. Am J Public Health. 2012 Feb;102(2):319-28. doi: 10.2105/AJPH.2011.300349. Epub 2011 Dec 15. — View Citation

Alegria M, Vallas M, Pumariega AJ. Racial and ethnic disparities in pediatric mental health. Child Adolesc Psychiatr Clin N Am. 2010 Oct;19(4):759-74. doi: 10.1016/j.chc.2010.07.001. — View Citation

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.

Barkley RA, Shelton TL, Crosswait C, Moorehouse M, Fletcher K, Barrett S, Jenkins L, Metevia L. Multi-method psycho-educational intervention for preschool children with disruptive behavior: preliminary results at post-treatment. J Child Psychol Psychiatry. 2000 Mar;41(3):319-32. — View Citation

Blanco C, Patel SR, Liu L, Jiang H, Lewis-Fernandez R, Schmidt AB, Liebowitz MR, Olfson M. National trends in ethnic disparities in mental health care. Med Care. 2007 Nov;45(11):1012-9. doi: 10.1097/MLR.0b013e3180ca95d3. — View Citation

Briggs-Gowan MJ, Carter AS, Skuban EM, Horwitz SM. Prevalence of social-emotional and behavioral problems in a community sample of 1- and 2-year-old children. J Am Acad Child Adolesc Psychiatry. 2001 Jul;40(7):811-9. doi: 10.1097/00004583-200107000-00016. — View Citation

Burke JD, Waldman I, Lahey BB. Predictive validity of childhood oppositional defiant disorder and conduct disorder: implications for the DSM-V. J Abnorm Psychol. 2010 Nov;119(4):739-51. doi: 10.1037/a0019708. — View Citation

Burnett-Zeigler I, Lee Y, Bohnert KM. Ethnic Identity, Acculturation, and 12-Month Psychiatric Service Utilization Among Black and Hispanic Adults in the U.S. J Behav Health Serv Res. 2018 Jan;45(1):13-30. doi: 10.1007/s11414-017-9557-8. — View Citation

Bussing R, Zima BT, Gary FA, Garvan CW. Barriers to detection, help-seeking, and service use for children with ADHD symptoms. J Behav Health Serv Res. 2003 Apr-Jun;30(2):176-89. doi: 10.1007/BF02289806. — View Citation

Bussing R, Zima BT, Perwien AR, Belin TR, Widawski M. Children in special education programs: attention deficit hyperactivity disorder, use of services, and unmet needs. Am J Public Health. 1998 Jun;88(6):880-6. doi: 10.2105/ajph.88.6.880. — View Citation

Butler AM, Titus C. Systematic Review of Engagement in Culturally Adapted Parent Training for Disruptive Behavior. J Early Interv. 2015 Dec;37(4):300-318. doi: 10.1177/1053815115620210. — View Citation

Chronis AM, Jones HA, Raggi VL. Evidence-based psychosocial treatments for children and adolescents with attention-deficit/hyperactivity disorder. Clin Psychol Rev. 2006 Aug;26(4):486-502. doi: 10.1016/j.cpr.2006.01.002. Epub 2006 Feb 17. — View Citation

Cunningham CE, Boyle M, Offord D, Racine Y, Hundert J, Secord M, McDonald J. Tri-ministry study: correlates of school-based parenting course utilization. J Consult Clin Psychol. 2000 Oct;68(5):928-33. — View Citation

Eiraldi RB, Mazzuca LB, Clarke AT, Power TJ. Service Utilization among ethnic minority children with ADHD: a model of help-seeking behavior. Adm Policy Ment Health. 2006 Sep;33(5):607-22. doi: 10.1007/s10488-006-0063-1. — View Citation

Eyberg SM, Nelson MM, Boggs SR. Evidence-based psychosocial treatments for children and adolescents with disruptive behavior. J Clin Child Adolesc Psychol. 2008 Jan;37(1):215-37. doi: 10.1080/15374410701820117. — View Citation

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

Fabrega H Jr, Ulrich R, Mezzich JE. Do Caucasian and black adolescents differ at psychiatric intake? J Am Acad Child Adolesc Psychiatry. 1993 Mar;32(2):407-13. doi: 10.1097/00004583-199303000-00023. — View Citation

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.

Flores G; Committee On Pediatric Research. Technical report--racial and ethnic disparities in the health and health care of children. Pediatrics. 2010 Apr;125(4):e979-e1020. doi: 10.1542/peds.2010-0188. Epub 2010 Mar 29. — View Citation

Forehand R, Kotchick BA. Cultural Diversity: A Wake-Up Call for Parent Training - Republished Article. Behav Ther. 2016 Nov;47(6):981-992. doi: 10.1016/j.beth.2016.11.010. Epub 2016 Nov 10. — View Citation

Garland AF, Lau AS, Yeh M, McCabe KM, Hough RL, Landsverk JA. Racial and ethnic differences in utilization of mental health services among high-risk youths. Am J Psychiatry. 2005 Jul;162(7):1336-43. doi: 10.1176/appi.ajp.162.7.1336. — View Citation

Gopalan G, Goldstein L, Klingenstein K, Sicher C, Blake C, McKay MM. Engaging families into child mental health treatment: updates and special considerations. J Can Acad Child Adolesc Psychiatry. 2010 Aug;19(3):182-96. — View Citation

Gross DA, Belcher HM, Ofonedu ME, Breitenstein S, Frick KD, Chakra B. Study protocol for a comparative effectiveness trial of two parent training programs in a fee-for-service mental health clinic: can we improve mental health services to low-income families? Trials. 2014 Mar 1;15:70. doi: 10.1186/1745-6215-15-70. — View Citation

Hall GC, Ibaraki AY, Huang ER, Marti CN, Stice E. A Meta-Analysis of Cultural Adaptations of Psychological Interventions. Behav Ther. 2016 Nov;47(6):993-1014. doi: 10.1016/j.beth.2016.09.005. Epub 2016 Sep 30. — View Citation

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.

Hoza B. Peer functioning in children with ADHD. J Pediatr Psychol. 2007 Jul;32(6):655-63. doi: 10.1093/jpepsy/jsm024. Epub 2007 Jun 7. — View Citation

Ingoldsby EM. Review of Interventions to Improve Family Engagement and Retention in Parent and Child Mental Health Programs. J Child Fam Stud. 2010 Oct 1;19(5):629-645. doi: 10.1007/s10826-009-9350-2. — View Citation

Kataoka SH, Zhang L, Wells KB. Unmet need for mental health care among U.S. children: variation by ethnicity and insurance status. Am J Psychiatry. 2002 Sep;159(9):1548-55. doi: 10.1176/appi.ajp.159.9.1548. — View Citation

Kazdin AE, Whitley M, Marciano PL. Child-therapist and parent-therapist alliance and therapeutic change in the treatment of children referred for oppositional, aggressive, and antisocial behavior. J Child Psychol Psychiatry. 2006 May;47(5):436-45. doi: 10.1111/j.1469-7610.2005.01475.x. — View Citation

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.

Kim-Cohen J, Caspi A, Moffitt TE, Harrington H, Milne BJ, Poulton R. Prior juvenile diagnoses in adults with mental disorder: developmental follow-back of a prospective-longitudinal cohort. Arch Gen Psychiatry. 2003 Jul;60(7):709-17. doi: 10.1001/archpsyc.60.7.709. — View Citation

Kirmayer LJ. Beyond the 'new cross-cultural psychiatry': cultural biology, discursive psychology and the ironies of globalization. Transcult Psychiatry. 2006 Mar;43(1):126-44. doi: 10.1177/1363461506061761. — View Citation

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.

Lavigne JV, Lebailly SA, Gouze KR, Binns HJ, Keller J, Pate L. Predictors and correlates of completing behavioral parent training for the treatment of oppositional defiant disorder in pediatric primary care. Behav Ther. 2010 Jun;41(2):198-211. doi: 10.1016/j.beth.2009.02.006. Epub 2009 Dec 5. — View Citation

Leijten P, Raaijmakers MA, de Castro BO, Matthys W. Does socioeconomic status matter? A meta-analysis on parent training effectiveness for disruptive child behavior. J Clin Child Adolesc Psychol. 2013;42(3):384-92. doi: 10.1080/15374416.2013.769169. Epub 2013 Mar 5. — View Citation

Lewis-Fernandez R, Aggarwal NK, Baarnhielm S, Rohlof H, Kirmayer LJ, Weiss MG, Jadhav S, Hinton L, Alarcon RD, Bhugra D, Groen S, van Dijk R, Qureshi A, Collazos F, Rousseau C, Caballero L, Ramos M, Lu F. Culture and psychiatric evaluation: operationalizing cultural formulation for DSM-5. Psychiatry. 2014 Summer;77(2):130-54. doi: 10.1521/psyc.2014.77.2.130. — View Citation

Lewis-Fernandez R, Aggarwal NK, Lam PC, Galfalvy H, Weiss MG, Kirmayer LJ, Paralikar V, Deshpande SN, Diaz E, Nicasio AV, Boiler M, Alarcon RD, Rohlof H, Groen S, van Dijk RC, Jadhav S, Sarmukaddam S, Ndetei D, Scalco MZ, Bassiri K, Aguilar-Gaxiola S, Ton H, Westermeyer J, Vega-Dienstmaier JM. Feasibility, acceptability and clinical utility of the Cultural Formulation Interview: mixed-methods results from the DSM-5 international field trial. Br J Psychiatry. 2017 Apr;210(4):290-297. doi: 10.1192/bjp.bp.116.193862. Epub 2017 Jan 19. — View Citation

Lewis-Fernandez R, Balan IC, Patel SR, Sanchez-Lacay JA, Alfonso C, Gorritz M, Blanco C, Schmidt A, Jiang H, Schneier F, Moyers TB. Impact of motivational pharmacotherapy on treatment retention among depressed Latinos. Psychiatry. 2013 Fall;76(3):210-22. doi: 10.1521/psyc.2013.76.3.210. — View Citation

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.

Matos M, Bauermeister JJ, Bernal G. Parent-child interaction therapy for Puerto Rican preschool children with ADHD and behavior problems: a pilot efficacy study. Fam Process. 2009 Jun;48(2):232-52. doi: 10.1111/j.1545-5300.2009.01279.x. — View Citation

Matos M, Torres R, Santiago R, Jurado M, Rodriguez I. Adaptation of parent-child interaction therapy for Puerto Rican families: a preliminary study. Fam Process. 2006 Jun;45(2):205-22. doi: 10.1111/j.1545-5300.2006.00091.x. — View Citation

McCabe K, Yeh M. Parent-child interaction therapy for Mexican Americans: a randomized clinical trial. J Clin Child Adolesc Psychol. 2009 Sep;38(5):753-9. doi: 10.1080/15374410903103544. — View Citation

McKay MM, Bannon WM Jr. Engaging families in child mental health services. Child Adolesc Psychiatr Clin N Am. 2004 Oct;13(4):905-21, vii. doi: 10.1016/j.chc.2004.04.001. — View Citation

McKay MM, McCadam K, Gonzales JJ. Addressing the barriers to mental health services for inner city children and their caretakers. Community Ment Health J. 1996 Aug;32(4):353-61. doi: 10.1007/BF02249453. — View Citation

McKay MM, Pennington J, Lynn CJ, McCadam K. Understanding urban child mental health l service use: two studies of child, family, and environmental correlates. J Behav Health Serv Res. 2001 Nov;28(4):475-83. doi: 10.1007/BF02287777. — View Citation

McMahon RJ, Frick PJ. Evidence-based assessment of conduct problems in children and adolescents. J Clin Child Adolesc Psychol. 2005 Sep;34(3):477-505. doi: 10.1207/s15374424jccp3403_6. — View Citation

Merikangas KR, He JP, Burstein M, Swendsen J, Avenevoli S, Case B, Georgiades K, Heaton L, Swanson S, Olfson M. Service utilization for lifetime mental disorders in U.S. adolescents: results of the National Comorbidity Survey-Adolescent Supplement (NCS-A). J Am Acad Child Adolesc Psychiatry. 2011 Jan;50(1):32-45. doi: 10.1016/j.jaac.2010.10.006. Epub 2010 Dec 3. — View Citation

Mezzich JE, Caracci G, Fabrega H Jr, Kirmayer LJ. Cultural formulation guidelines. Transcult Psychiatry. 2009 Sep;46(3):383-405. doi: 10.1177/1363461509342942. — View Citation

Miranda J, Bernal G, Lau A, Kohn L, Hwang WC, LaFromboise T. State of the science on psychosocial interventions for ethnic minorities. Annu Rev Clin Psychol. 2005;1:113-42. doi: 10.1146/annurev.clinpsy.1.102803.143822. No abstract available. — View Citation

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.

Nixon RD, Sweeney L, Erickson DB, Touyz SW. Parent-child interaction therapy: one- and two-year follow-up of standard and abbreviated treatments for oppositional preschoolers. J Abnorm Child Psychol. 2004 Jun;32(3):263-71. doi: 10.1023/b:jacp.0000026140.60558.05. — View Citation

Nock MK, Kazdin AE, Hiripi E, Kessler RC. Lifetime prevalence, correlates, and persistence of oppositional defiant disorder: results from the National Comorbidity Survey Replication. J Child Psychol Psychiatry. 2007 Jul;48(7):703-13. doi: 10.1111/j.1469-7610.2007.01733.x. — View Citation

Novins DK, Bechtold DW, Sack WH, Thompson J, Carter DR, Manson SM. The DSM-IV Outline for Cultural Formulation: a critical demonstration with American Indian children. J Am Acad Child Adolesc Psychiatry. 1997 Sep;36(9):1244-51. doi: 10.1097/00004583-199709000-00017. — View Citation

Owens J. Early Childhood Behavior Problems and the Gender Gap in Educational Attainment in the United States. Sociol Educ. 2016;89(3):236-258. doi: 10.1177/0038040716650926. Epub 2016 Jun 22. — View Citation

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.

Richardson LA. Seeking and obtaining mental health services: what do parents expect? Arch Psychiatr Nurs. 2001 Oct;15(5):223-31. doi: 10.1053/apnu.2001.27019. — View Citation

Rowe R, Costello EJ, Angold A, Copeland WE, Maughan B. Developmental pathways in oppositional defiant disorder and conduct disorder. J Abnorm Psychol. 2010 Nov;119(4):726-38. doi: 10.1037/a0020798. — View Citation

Schim SM, Doorenbos AZ, Miller J, Benkert R. Development of a Cultural Competence Assessment instrument. J Nurs Meas. 2003 Spring-Summer;11(1):29-40. doi: 10.1891/jnum.11.1.29.52062. — View Citation

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.

Sue S, Fujino DC, Hu LT, Takeuchi DT, Zane NW. Community mental health services for ethnic minority groups: a test of the cultural responsiveness hypothesis. J Consult Clin Psychol. 1991 Aug;59(4):533-40. doi: 10.1037//0022-006x.59.4.533. — View Citation

Sue S, Zane N. The role of culture and cultural techniques in psychotherapy. A critique and reformulation. Am Psychol. 1987 Jan;42(1):37-45. doi: 10.1037//0003-066x.42.1.37. No abstract available. — View Citation

Takeuchi J. Treatment of a biracial child with schizophreniform disorder: cultural formulation. Cultur Divers Ethnic Minor Psychol. 2000 Feb;6(1):93-101. doi: 10.1037/1099-9809.6.1.93. — View Citation

Turner EA. The parental attitudes toward psychological services inventory: adaptation and development of an attitude scale. Community Ment Health J. 2012 Aug;48(4):436-49. doi: 10.1007/s10597-011-9432-7. Epub 2011 Jun 21. — View Citation

Yasui M, Hipwell AE, Stepp SD, Keenan K. Psychocultural Correlates of Mental Health Service Utilization Among African American and European American Girls. Adm Policy Ment Health. 2015 Nov;42(6):756-66. doi: 10.1007/s10488-014-0610-0. — View Citation

Young AS, Rabiner D. Racial/ethnic differences in parent-reported barriers to accessing children's health services. Psychol Serv. 2015 Aug;12(3):267-73. doi: 10.1037/a0038701. Epub 2015 Jan 19. — View Citation

* Note: There are 77 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
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.
Post Intake Assessment (Week 0)
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.
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.
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. 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.
Change from Baseline (Week 0) through post treatment (anticipated average: Week 14)
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) Change from Baseline (Week 0) through post treatment
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. 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.
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.
Post Intake Assessment (Week 0)
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.
Post Intake Assessment (Week 0)
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.
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.
Post Intake Assessment (Week 0)
See also
  Status Clinical Trial Phase
Completed NCT04628546 - The Parenting Young Children Check-up Evaluation N/A
Completed NCT03378245 - Telemedicine-based, Multidisciplinary-team, Intervention to Reduce Unnecessary Hospitalizations N/A
Completed NCT03697837 - Digital Parent Training for Disruptive Behaviors in Children N/A
Completed NCT04199533 - Iterative Redesign of a Behavioral Skills Training Program for Use in Educational Settings
Recruiting NCT05093686 - RUBIES in Educational Settings N/A
Completed NCT03710642 - Prazosin for Agitation in Alzheimer's Disease Phase 2
Recruiting NCT05591820 - A Randomized Controlled Trial on Brief Behavioral Parent Training N/A
Completed NCT06217146 - A Medical Cannabis Oil for Treatment of Agitation and Disruptive Behaviors in Subjects With Dementia. N/A
Recruiting NCT06241300 - Executive Function and Parenting in Childhood N/A
Completed NCT01965184 - Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents N/A
Recruiting NCT02828969 - Clinical and Social Trajectory of Children and Adolescents With Disruptive Behavior N/A
Recruiting NCT06447909 - Randomized Controlled Trial of a Behavioral Training App N/A
Completed NCT05077722 - Monitoring of Sleep and Behavior of Children 3-7 Years Old Receiving Parent-Child Interaction Therapy With the Help of Artificial Intelligence N/A
Completed NCT05113147 - Disruptive Behavior in the Operating Room
Completed NCT05725525 - A Study of Internet Delivered Parent Child Interaction Therapy N/A
Completed NCT05452954 - Psychosocial ADHD Interventions - Brief Parent Training N/A
Completed NCT03260816 - Advancing Child Competencies by Extending Supported Services (ACCESS) for Families Program N/A
Completed NCT03510156 - Treatment of Disruptive Behaviors in Fragile X Syndrome N/A
Completed NCT03906682 - Improving Mental Health and School Performance in Urban Eighth Graders N/A
Recruiting NCT06346782 - Feasibility and Acceptability of Internet-based Parent-child Interaction Therapy (I-PCIT) in Pediatric Cancer N/A