The Impact of Parent Training on the Child's Health Services

Parenting Clinical Trial

Official title:

The Impact of Evidence-Based Parent Training on Pediatric Health Services Utilization

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03704974
• Other study ID #: CHLA-17-00001
• Secondary ID: UL1TR001855
• Status: Suspended
• Start date: August 16, 2018
• Est. completion date: November 2024

Study information

• Verified date: January 2024
• Source: Children's Hospital Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to determine whether parent training with the Incredible Years Parent Program delivered in pediatric primary care decreases usage of healthcare services for the next year when compared to annual healthcare service use during the two years prior to the parents participating in program.

Description:

Pediatric health services utilization (pHSU) by children with mental health conditions demonstrated dramatic increases between 2006 and 2011. These national trends reflecting large increases in pHSU for mental health conditions were seen across multiple developmental levels. Health services costs for children with mental health conditions are estimated to be twice those for the average child. The Incredible Years® Parent Program (IY) has a strong evidence-base supporting its effectiveness in reducing early onset conduct problems. The overall objective of this stage 3 (T3) translational research proposal is to conduct a pilot study of 45 pediatrician-referred parents who participate in IY and examine the impact of IY on pHSU of their children. Pediatric HSU outcome measures include: all-cause ED visits; in-patient hospitalizations and length of stay; authorizations for specialist referrals; primary and acute care visits; and ED visits for mental health conditions. The investigator's central hypothesis is that children ages 3 to 6 years with behavior concerns whose parents are referred by their pediatricians for participation in IY will have decreased mean annual all-cause pHSU and decreased ED visits for mental health conditions in the 12 months following IY, compared to the 24 months prior to IY participation. This is important to demonstrate because significant financial barriers exist to integrating effective family focused prevention services like IY into pediatric primary care settings. Demonstration of reduced pHSU is one way to address these translational barriers. Results of this pilot study are expected to provide preliminary data on pre- and post-intervention effect sizes; these data will be used to demonstrate the feasibility of collecting data using existing sources of pHSU to design a more fully powered multi-site trial with a robust comparator group.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 45
• Est. completion date: November 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 36 Months to 83 Months

Eligibility

Inclusion Criteria:

• Children receiving primary care at CHLA AltaMed with parent-reported behavioral concerns whose parents are referred by their pediatricians for participation in the Incredible Years Parenting Program.

• Continuous enrollment in AltaMed Medicaid funded health services during the 24 months prior to participation in IY and 12 months following participation in IY with lapses in coverage of no more than 90 days in length.

• Parents are English or Spanish-speaking or willing to use interpretation if they speak another language.

Exclusion Criteria:

• Private (commercial non-Medicaid) insurance coverage for greater than 90 days during the 24 months prior to participation in IY and 12 months following participation in IY.

Related Conditions & MeSH terms

• Child Behavior Problem
• Child Rearing
• Parenting
• Problem Behavior

Intervention

Behavioral:
• Video-Based Parent Training Program
An18-20 week evidence-based social cognitive theory-based parenting program where parents see brief video vignettes of effective and less effective parenting and develop concepts to modify their child's behavior.

Locations

Country	Name	City	State
United States	Children's Hospital Los Angeles	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles	AltaMed Health Services Corporation, National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

References & Publications (33)

American Academy of Child and Adolescent Psychiatry Committee on Health Care Access and Economics Task Force on Mental Health. Improving mental health services in primary care: reducing administrative and financial barriers to access and collaboration. Pediatrics. 2009 Apr;123(4):1248-51. doi: 10.1542/peds.2009-0048. No abstract available. Erratum In: Pediatrics. 2009 Jun;123(6):1611. — View Citation

Case A, Fertig A, Paxson C. The lasting impact of childhood health and circumstance. J Health Econ. 2005 Mar;24(2):365-89. doi: 10.1016/j.jhealeco.2004.09.008. Epub 2005 Jan 5. — View Citation

Champagne FA, Weaver IC, Diorio J, Dymov S, Szyf M, Meaney MJ. Maternal care associated with methylation of the estrogen receptor-alpha1b promoter and estrogen receptor-alpha expression in the medial preoptic area of female offspring. Endocrinology. 2006 Jun;147(6):2909-15. doi: 10.1210/en.2005-1119. Epub 2006 Mar 2. — View Citation

Dawson G, Ashman SB, Carver LJ. The role of early experience in shaping behavioral and brain development and its implications for social policy. Dev Psychopathol. 2000 Autumn;12(4):695-712. doi: 10.1017/s0954579400004089. — View Citation

Eyberg SM, Pincus D. Eyberg child behavior inventory and sutter-eyberg student behavior inventory-revised: Professional manual. Psychological Assessment Resources; 1999.

Fox SE, Levitt P, Nelson CA 3rd. How the timing and quality of early experiences influence the development of brain architecture. Child Dev. 2010 Jan-Feb;81(1):28-40. doi: 10.1111/j.1467-8624.2009.01380.x. — View Citation

General US. Mental health: A report of the surgeon general. Rockville, MD: US Department of Health and Human Services. Substance Abuse and Mental Health Services Administration, Center for Mental Health Services, National Institutes of Health, National Institute of Mental Health. 1999.

Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30. — View Citation

Hertzman C, Boyce T. How experience gets under the skin to create gradients in developmental health. Annu Rev Public Health. 2010;31:329-47 3p following 347. doi: 10.1146/annurev.publhealth.012809.103538. — View Citation

Jellinek MS, Murphy JM, Little M, Pagano ME, Comer DM, Kelleher KJ. Use of the Pediatric Symptom Checklist to screen for psychosocial problems in pediatric primary care: a national feasibility study. Arch Pediatr Adolesc Med. 1999 Mar;153(3):254-60. doi: 10.1001/archpedi.153.3.254. — View Citation

Kershaw P, Irwin L, Trafford K, Hertzman C. The British Columbia atlas of child development (Vol. 40). Vancouver, BC: Human Early Learning Partnership; 2005.

Kubicek K, Liu D, Beaudin C, Supan J, Weiss G, Lu Y, Kipke MD. A profile of nonurgent emergency department use in an urban pediatric hospital. Pediatr Emerg Care. 2012 Oct;28(10):977-84. doi: 10.1097/PEC.0b013e31826c9aab. — View Citation

Leslie LK, Mehus CJ, Hawkins JD, Boat T, McCabe MA, Barkin S, Perrin EC, Metzler CW, Prado G, Tait VF, Brown R, Beardslee W. Primary Health Care: Potential Home for Family-Focused Preventive Interventions. Am J Prev Med. 2016 Oct;51(4 Suppl 2):S106-18. doi: 10.1016/j.amepre.2016.05.014. Epub 2016 Aug 3. — View Citation

McCart MR, Priester PE, Davies WH, Azen R. Differential effectiveness of behavioral parent-training and cognitive-behavioral therapy for antisocial youth: a meta-analysis. J Abnorm Child Psychol. 2006 Aug;34(4):527-43. doi: 10.1007/s10802-006-9031-1. Epub 2006 Jul 13. — View Citation

Menting AT, Orobio de Castro B, Matthys W. Effectiveness of the Incredible Years parent training to modify disruptive and prosocial child behavior: a meta-analytic review. Clin Psychol Rev. 2013 Dec;33(8):901-13. doi: 10.1016/j.cpr.2013.07.006. Epub 2013 Jul 22. — View Citation

Patel V, Flisher AJ, Hetrick S, McGorry P. Mental health of young people: a global public-health challenge. Lancet. 2007 Apr 14;369(9569):1302-1313. doi: 10.1016/S0140-6736(07)60368-7. — View Citation

Perou R, Bitsko RH, Blumberg SJ, Pastor P, Ghandour RM, Gfroerer JC, Hedden SL, Crosby AE, Visser SN, Schieve LA, Parks SE, Hall JE, Brody D, Simile CM, Thompson WW, Baio J, Avenevoli S, Kogan MD, Huang LN; Centers for Disease Control and Prevention (CDC). Mental health surveillance among children--United States, 2005-2011. MMWR Suppl. 2013 May 17;62(2):1-35. — View Citation

Reid MJ, Webster-Stratton C, Baydar N. Halting the development of conduct problems in head start children: the effects of parent training. J Clin Child Adolesc Psychol. 2004 Jun;33(2):279-91. doi: 10.1207/s15374424jccp3302_10. — View Citation

Reid MJ, Webster-Stratton C, Beauchaine TP. Parent training in head start: a comparison of program response among African American, Asian American, Caucasian, and Hispanic mothers. Prev Sci. 2001 Dec;2(4):209-27. doi: 10.1023/a:1013618309070. — View Citation

Saxena S, Thornicroft G, Knapp M, Whiteford H. Resources for mental health: scarcity, inequity, and inefficiency. Lancet. 2007 Sep 8;370(9590):878-89. doi: 10.1016/S0140-6736(07)61239-2. — View Citation

Scott S, Briskman J, O'Connor TG. Early prevention of antisocial personality: long-term follow-up of two randomized controlled trials comparing indicated and selective approaches. Am J Psychiatry. 2014 Jun;171(6):649-57. doi: 10.1176/appi.ajp.2014.13050697. — View Citation

Scott S, Spender Q, Doolan M, Jacobs B, Aspland H. Multicentre controlled trial of parenting groups for childhood antisocial behaviour in clinical practice. BMJ. 2001 Jul 28;323(7306):194-8. doi: 10.1136/bmj.323.7306.194. — View Citation

Scott S, Sylva K, Doolan M, Price J, Jacobs B, Crook C, Landau S. Randomised controlled trial of parent groups for child antisocial behaviour targeting multiple risk factors: the SPOKES project. J Child Psychol Psychiatry. 2010 Jan;51(1):48-57. doi: 10.1111/j.1469-7610.2009.02127.x. Epub 2009 Sep 1. — View Citation

Soni, Anita. The Five Most Costly Children's Conditions, 2006: Estimates for the U.S. Civilian Noninstitutionalized Children, Ages 0-17. Statistical Brief #242. April 2009. Agency for Healthcare Research and Quality, Rockville, MD. . http://www.meps.ahrq.gov/mepsweb/data_files/publications/st242/stat242.shtml

Torio CM, Encinosa W, Berdahl T, McCormick MC, Simpson LA. Annual report on health care for children and youth in the United States: national estimates of cost, utilization and expenditures for children with mental health conditions. Acad Pediatr. 2015 Jan-Feb;15(1):19-35. doi: 10.1016/j.acap.2014.07.007. Epub 2014 Nov 13. — View Citation

US Department of Health and Human Services. The national survey of children's health 2007. US Department of Health and Human Services, Health Resources and Service Administration, Maternal and Child Health Bureau, Rockville, MD. 2009.

Walker SP, Wachs TD, Grantham-McGregor S, Black MM, Nelson CA, Huffman SL, Baker-Henningham H, Chang SM, Hamadani JD, Lozoff B, Gardner JM, Powell CA, Rahman A, Richter L. Inequality in early childhood: risk and protective factors for early child development. Lancet. 2011 Oct 8;378(9799):1325-38. doi: 10.1016/S0140-6736(11)60555-2. Epub 2011 Sep 22. — View Citation

Webster-Stratton C, Reid MJ, Beauchaine TP. One-year follow-up of combined parent and child intervention for young children with ADHD. J Clin Child Adolesc Psychol. 2013;42(2):251-61. doi: 10.1080/15374416.2012.723263. Epub 2012 Sep 28. — View Citation

Webster-Stratton C, Rinaldi J, Jamila MR. Long-Term Outcomes of Incredible Years Parenting Program: Predictors of Adolescent Adjustment. Child Adolesc Ment Health. 2011 Feb;16(1):38-46. doi: 10.1111/j.1475-3588.2010.00576.x. — View Citation

Webster-Stratton C. Preventing conduct problems in Head Start children: strengthening parenting competencies. J Consult Clin Psychol. 1998 Oct;66(5):715-30. doi: 10.1037//0022-006x.66.5.715. — View Citation

Webster-Stratton, C. The Incredible Years®: parents, teachers and children training series. Leader's guide: Preschool version of BASIC. 2008. Seattle, WA

Wells MG, Burlingame GM, Lambert MJ, Hoag MJ, Hope CA. Conceptualization and measurement of patient change during psychotherapy: Development of the Outcome Questionnaire and Youth Outcome Questionnaire. Psychotherapy: Theory, Research, Practice, Training. 1996;33(2):275. doi:10.1037/0033-3204.33.2.275

Yousafzai AK, Rasheed MA, Rizvi A, Armstrong R, Bhutta ZA. Effect of integrated responsive stimulation and nutrition interventions in the Lady Health Worker programme in Pakistan on child development, growth, and health outcomes: a cluster-randomised factorial effectiveness trial. Lancet. 2014 Oct 4;384(9950):1282-93. doi: 10.1016/S0140-6736(14)60455-4. Epub 2014 Jun 16. — View Citation

* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Annual Pediatric Health Services Utilization from 24 months prior to IY Parent Group Participation to 12 months following IY Parent Group Participation	(1) all-cause Emergency Department (ED) visits (yes/no) and number; (2) ED visits for mental health conditions (yes/no) and number; (3) in-patient hospitalizations (yes/no) and number, and length of stay in days; (4) authorizations for specialist referrals from AltaMed (yes/no) and number; (5) number of AltaMed primary care visits; (6) AltaMed acute care visits (yes/no) and number; (7) AltaMed mental health visits (yes/no) and number; (8) Children's Hospital Los Angeles (CHLA) specialty mental health visits (yes/no) and number.	Utilization for 24 months prior to intervention and 12 months following intervention
Secondary	Eyberg Child Behavior Inventory	Raw and T-scores for Intensity [measures frequency of problem behaviors; range 36 to 252; higher worse] and Problem [measures number of behaviors that are a problem for the parent; range 0 to 36; higher worse] Subscales	During week before or after starting group; and during week before or after ending group, up to 20 weeks
Secondary	Youth Outcome Questionnaire (Parent Report)	Total raw score [measures change in frequency of child symptoms and prosocial behaviors; range -16 to 240; higher worse].	During week before or after starting group; and during week before or after ending group, up to 20 weeks
Secondary	Pediatric Symptom Checklist	Total raw score [measures frequency of pediatric psychosocial problems; range 0 to 70; higher worse].	During week before or after starting group; and during week before or after ending group, up to 20 weeks

External Links

•   Link to REDCap Database