Incredible Years® – Preschool Basic Program

Mental Health Does Not Currently Meet Criteria

Incredible Years – Preschool Basic Program (“IY-Preschool”) can be offered as a group-based prevention or treatment program for parents of children (3 to 6 years). The program typically targets higher-risk populations and parents of children diagnosed with problems such as oppositional defiant disorder and attention deficit hyperactivity disorder (ADHD). IY-Preschool aims to help parents implement positive discipline. It also aims to strengthen their child’s social, emotional, academic and self-regulation skills and reduce behavior problems.

 

IY-Preschool focuses on four developmentally appropriate topics during the sessions: (1) strengthening children’s social skills, emotion regulation, and school readiness, (2) using praise and incentives, (3) effective limit setting, and (4) handling misbehavior.

 

During each group session, parents watch 8 to 10 situational video vignettes. They engage in discussions facilitated by the group leaders and problem solve about best parenting practices. Parents are also encouraged to complete activities at home to apply the skills they learned with the group with their children.


IY-Preschool does not currently meet criteria to receive a rating because no studies of the program achieved a rating of moderate or high on design and execution.


Date Research Evidence Last Reviewed: Aug 2020


Sources

The program or service description, target population, and program or service delivery and implementation information was informed by the following sources: the program or service developer’s website, the program or service manual, and the studies reviewed.


This information does not necessarily represent the views of the program or service developers. For more information on how this program or service was reviewed, visit the Review Process page or download the Handbook.

Target Population

IY-Preschool is designed for parents of children who are 3 to 6 years old. The program typically targets higher-risk populations and parents of children diagnosed with problems such as oppositional defiant disorder and attention deficit hyperactivity disorder (ADHD).

Dosage

Parents typically receive 14 to 20 weekly group sessions of IY-Preschool. Each group session lasts 2 to 2.5 hours.

Location/Delivery Setting
Recommended Locations/Delivery Settings

The IY-Preschool program is typically delivered in a community setting.

Education, Certifications and Training

Incredible Years® offers a three-day in-person training for IY-Preschool group leaders. The training is highly recommended for all group leaders and is required for group leaders who plan to become certified. It is recommended that at least one of the two leaders working with a group has a master’s degree or comparable education/background. Group leaders who have attended IY-Preschool training can become certified by demonstrating positive participant evaluations, positive trainer/mentor evaluations of videotape review, positive peer review, and satisfactory completion of session protocols. Group leaders come from a variety of backgrounds, including social work, psychology, nursing, medicine or education. Additionally, they should have taken at least one course in child development or social learning theory.

Program or Service Documentation
Book/Manual/Available documentation used for review

IY-Preschool uses the Incredible Years Parents, Teachers and Children’s Training Series group leader manual. It is implemented in conjunction with the Curriculum Set below that is specific to the IY-Preschool program.

Webster-Stratton, C. (2011). Incredible Years parents, teachers and children’s training series: Program content, methods, research, and dissemination, 1980 – 2011. Incredible Years, Inc.

Incredible Years, Inc. (2019). Preschool basic curriculum set.

Available languages

Materials for IY-Preschool are available in English, Spanish, French, Danish, Dutch, Finnish, Norwegian, Portuguese, Russian, and Estonian.

Other supporting materials

Program overview

Certification

Training Workshops

For More Information

Website: http://www.incredibleyears.com/

Phone: (206) 285-7565

Email: incredibleyears@incredibleyears.com


Note: The details on Dosage; Location; Education, Certifications, and Training; Other Supporting Materials; and For More Information sections above are provided to website users for informational purposes only. This information is not exhaustive and may be subject to change.

Results of Search and Review Number of Studies Identified and Reviewed for Incredible Years® – Preschool Basic Program
Identified in Search 38
Eligible for Review 1
Rated High 0
Rated Moderate 0
Rated Low 1
Reviewed Only for Risk of Harm 0
Sometimes study results are reported in more than one document, or a single document reports results from multiple studies. Studies are identified below by their Prevention Services Clearinghouse study identification numbers. To receive a rating of supported or well-supported, the favorable evidence for a program or service must have been obtained from research conducted in a usual care or practice setting.


Studies Rated Low

Study 10683

Leckey, Y., McGilloway, S., Hickey, G., Bracken-Scally, M., Kelly, P., & Furlong, M. (2019). A randomised control trial of parent and child training programmes (versus wait list control) for children with ADHD-type behaviours: A pilot study. Child Care in Practice, 25(4), 419-438. doi:10.1080/13575279.2018.1481368

This study received a low rating because the standards for addressing missing data were not met.


Studies Not Eligible for Review

Study 10653

Axberg, U., & Broberg, A. G. (2012). Evaluation of "The Incredible Years" in Sweden: The transferability of an American parent-training program to Sweden. Scandinavian Journal of Psychology, 53(3), 224-232. https://doi.org/10.1111/j.1467-9450.2012.00955.x

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10654

Azevedo, A. F., Seabra-Santos, M. J., Gaspar, M. F., & Homem, T. C. (2013). The Incredible Years Basic Parent Training for Portuguese preschoolers with AD/HD behaviors: Does it make a difference? Child & Youth Care Forum, 42(5), 403-424. https://doi.org/10.1007/s10566-013-9207-0

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10657

Brotman, L. M., Gouley, K. K., Chesir-Teran, D., Dennis, T., Klein, R. G., & Shrout, P. (2005). Prevention for preschoolers at high risk for conduct problems: Immediate outcomes on parenting practices and child social competence. Journal of Clinical Child and Adolescent Psychology, 34(4), 724-734. https://doi.org/10.1207/s15374424jccp3404_14

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10658

Chhangur, R. R., Weeland, J., Overbeek, G., Matthys, W., Castro, B., Giessen, D., & Belsky, J. (2017). Genetic moderation of intervention efficacy: Dopaminergic genes, The Incredible Years, and externalizing behavior in children. Child Development, 88(3), 796-811. https://doi.org/10.1111/cdev.12612

Chhangur, R. R., Weeland, J., Overbeek, G., Matthys, W., & Orobio de Castro, B. (2012). ORCHIDS: An observational randomized controlled trial on childhood differential susceptibility. BMC Public Health, 12, 917-917. https://doi.org/10.1186/1471-2458-12-917

Overbeek, G. (2017). Parenting intervention effects on children’s externalizing behavior: The moderating role of genotype and temperament. Current Opinion in Psychology, 15, 143-148. https://doi.org/10.1016/j.copsyc.2017.02.025

van Aar, J., Leijten, P., Orobio de Castro, B., Weeland, J., Matthys, W., Chhangur, R., & Overbeek, G. (2019). Families who benefit and families who do not: Integrating person- and variable-centered analyses of parenting intervention responses. Journal of the American Academy of Child & Adolescent Psychiatry, 58(10), 993-1003. https://doi.org/10.1016/j.jaac.2019.02.004

Weeland, J., Chhangur, R. R., van der Giessen, D., Matthys, W., Orobio de Castro, B., & Overbeek, G. (2017). Intervention effectiveness of The Incredible Years: New insights into sociodemographic and intervention-based moderators. Behavior Therapy, 48(1), 1-18. https://doi.org/10.1016/j.beth.2016.08.002

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10659

Dionne, R., Davis, B., Sheeber, L., & Madrigal, L. (2009). Initial evaluation of a cultural approach to implementation of evidence-based parenting interventions in American Indian communities. Journal of Community Psychology, 37(7), 911-921. https://doi.org/10.1002/jcop.20336

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10660

Drugli, M. B., Fossum, S., Larsson, B., & Morch, W. T. (2010). Characteristics of young children with persistent conduct problems 1 year after treatment with the Incredible Years program. European Child & Adolescent Psychiatry, 19(7), 559-565. https://doi.org/10.1007/s00787-009-0083-y

Drugli, M. B., Larsson, B., & Clifford, G. (2007). Changes in social competence in young children treated because of conduct problems as viewed by multiple informants. European Child & Adolescent Psychiatry, 16(6), 370-378. https://doi.org/10.1007/s00787-007-0609-0

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10663

Gardner, F., Burton, J., & Klimes, I. (2006). Randomised controlled trial of a parenting intervention in the voluntary sector for reducing child conduct problems: Outcomes and mechanisms of change. Journal of Child Psychology and Psychiatry, 47(11), 1123-1132. https://doi.org/10.1111/j.1469-7610.2006.01668.x

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10668

Herman, K. C., Borden, L. A., Reinke, W. M., & Webster-Stratton, C. (2011). The impact of the Incredible Years parent, child, and teacher training programs on children's co-occurring internalizing symptoms. School Psychology Quarterly, 26(3), 189-201. https://doi.org/10.1037/a0025228

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10669

Homem, T. C., Gaspar, M. F., Seabra-Santos, M. J., Canavarro, M. C., & Azevedo, A. (2014). A pilot study with the Incredible Years Parenting Training: Does it work for fathers of preschoolers with oppositional behavior symptoms? Fathering, 12(3), 262-282. http://dx.doi.org/10.3149/fth.1203.262.

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10670

Hughes, J. R., & Gottlieb, L. N. (2004). The effects of the Webster-Stratton parenting program on maltreating families: Fostering strengths. Child Abuse & Neglect, 28(10), 1081-1097. https://doi.org/10.1016/j.chiabu.2004.02.004

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10671

Hurlburt, M. S., Nguyen, K., Reid, J., Webster-Stratton, C., & Zhang, J. (2013). Efficacy of the Incredible Years group parent program with families in Head Start who self-reported a history of child maltreatment. Child Abuse & Neglect, 37(8), 531-543. https://doi.org/10.1016/j.chiabu.2012.10.008

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10672

Gardner, F., Hutchings, J., Bywater, T., & Whitaker, C. (2010). Who benefits and how does it work? Moderators and mediators of outcome in an effectiveness trial of a parenting intervention. Journal of Clinical Child and Adolescent Psychology, 39(4), 568-580. https://doi.org/10.1080/15374416.2010.486315

Edwards, R. T., Céilleachair, A., Bywater, T., Hughes, D. A., & Hutchings, J. (2007). Parenting programme for parents of children at risk of developing conduct disorder: Cost effectiveness analysis. BMJ, 334(7595), 682-682. https://doi.org/10.1136/bmj.39126.699421.55

Hutchings, J., Gardner, F., Bywater, T., Daley, D., Whitaker, C., Jones, K., Eames, C., & Edwards, R. T. (2007). Parenting intervention in Sure Start services for children at risk of developing conduct disorder: Pragmatic randomised controlled trial. BMJ, 334(7595), 678-678. https://doi.org/10.1136/bmj.39126.620799.55

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10675

Jones, K., Daley, D., Hutchings, J., Bywater, T., & Eames, C. (2007). Efficacy of the Incredible Years Basic parent training programme as an early intervention for children with conduct problems and ADHD. Child: Care, Health and Development, 33(6), 749-756. https://doi.org/10.1111/j.1365-2214.2007.00747.x

Jones, K., Daley, D., Hutchings, J., Bywater, T., & Eames, C. (2008). Efficacy of the Incredible Years Programme as an early intervention for children with conduct problems and ADHD: Long-term follow-up. Child: Care, Health and Development, 34(3), 380-390. https://doi.org/10.1111/j.1365-2214.2008.00817.x

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10677

Karjalainen, P., Kiviruusu, O., Aronen, E. T., & Santalahti, P. (2019). Group-based parenting program to improve parenting and children's behavioral problems in families using special services: A randomized controlled trial in a real-life setting. Children and Youth Services Review, 96, 420-429. https://doi.org/10.1016/j.childyouth.2018.12.004

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10678

Kim, E., Cain, K. C., & Webster-Stratton, C. (2008). The preliminary effect of a parenting program for Korean American mothers: A randomized controlled experimental study. International Journal of Nursing Studies, 45(9), 1261-1273. https://doi.org/10.1016/j.ijnurstu.2007.10.002

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10680

Kong, M. M., & Au, T. K. (2018). The Incredible Years Parent Program for Chinese preschoolers with developmental disabilities. Early Education and Development, 29(4), 494-514. https://doi.org/10.1080/10409289.2018.1461987

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10681

Larsson, B., Fossum, S., Clifford, G., Drugli, M. B., Handegård, B. H., & Mørch, W.-T. (2009). Treatment of oppositional defiant and conduct problems in young Norwegian children: Results of a randomized controlled trial. European Child & Adolescent Psychiatry, 18(1), 42-52. https://doi.org/10.1007/s00787-008-0702-z

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10682

Lavigne, J. V., LeBailly, S. A., Gouze, K. R., Cicchetti, C., Pochyly, J., Arend, R., Jessup, B., & Binns, H. J. (2008). Treating oppositional defiant disorder in primary care: A comparison of three models. Journal of Pediatric Psychology, 33(5), 449-461. https://doi.org/10.1093/jpepsy/jsm074

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10684

Leijten, P., Melendez-Torres, G. J., Knerr, W., & Gardner, F. (2016). Transported versus homegrown parenting interventions for reducing disruptive child behavior: A multilevel meta-regression study. Journal of the American Academy of Child & Adolescent Psychiatry, 55(7), 610-617. https://doi.org/10.1016/j.jaac.2016.05.003

Leijten, P., Raaijmakers, M. A. J., Orobio de Castro, B., van den Ban, E., & Matthys, W. (2017). Effectiveness of the Incredible Years parenting program for families with socioeconomically disadvantaged and ethnic minority backgrounds. Journal of Clinical Child and Adolescent Psychology, 46(1), 59-73. https://doi.org/10.1080/15374416.2015.1038823

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10687

Linares, L. O., Montalto, D., Li, M., & Oza, V. S. (2006). A promising parenting intervention in foster care. Journal of Consulting and Clinical Psychology, 74(1), 32-41. https://doi.org/10.1037/0022-006X.74.1.32

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10688

McCann, D. C., Thompson, M., Daley, D., Barton, J., Laver-Bradbury, C., Hutchings, J., Coghill, D., Stanton, L., Maishman, T., Dixon, L., Caddy, J., Chorozoglou, M., Raftery, J., & Sonuga-Barke, E. (2014). Study protocol for a randomized controlled trial comparing the efficacy of a specialist and a generic parenting programme for the treatment of preschool ADHD. Trials, 15, 142-142. https://doi.org/10.1186/1745-6215-15-142

Sonuga-Barke, E. J. S., Barton, J., Daley, D., Hutchings, J., Maishman, T., Raftery, J., Stanton, L., Laver-Bradbury, C., Chorozoglou, M., Coghill, D., Little, L., Ruddock, M., Radford, M., Yao, G. L., Lee, L., Gould, L., Shipway, L., Markomichali, P., McGuirk, J., …, Thompson, M. J. J. (2018). A comparison of the clinical effectiveness and cost of specialised individually delivered parent training for preschool attention-deficit/hyperactivity disorder and a generic, group-based programme: A multi-centre, randomised controlled trial of the New Forest Parenting Programme versus Incredible Years. European Child & Adolescent Psychiatry, 27(6), 797–809. https://doi.org/10.1007/s00787-017-1054-3

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10689

McGilloway, S., Mhaille, G. N., Bywater, T., Furlong, M., Leckey, Y., Kelly, P., Comiskey, C., & Donnelly, M. (2012). A parenting intervention for childhood behavioral problems: A randomized controlled trial in disadvantaged community-based settings. Journal of Consulting and Clinical Psychology, 80(1), 116-127. https://doi.org/10.1037/a0026304

McGilloway, S., NiMhaille, G., Bywater, T., Leckey, Y., Kelly, P., Furlong, M., Comiskey, C., O’Neill, D., & Donnelly, M. (2014). Reducing child conduct disordered behaviour and improving parent mental health in disadvantaged families: A 12-month follow-up and cost analysis of a parenting intervention. European Child & Adolescent Psychiatry, 23(9), 783-794. https://doi.org/10.1007/s00787-013-0499-2

O'Neill, D., McGilloway, S., Donnelly, M., Bywater, T., & Kelly, P. (2013). A cost-effectiveness analysis of the Incredible Years parenting programme in reducing childhood health inequalities. The European Journal of Health Economics, 14(1), 85-94. https://doi.org/10.1007/s10198-011-0342-y

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10690

McIntyre, L. L. (2008). Parent training for young children with developmental disabilities: Randomized controlled trial. American Journal on Mental Retardation, 113(5), 356-368. https://doi.org/10.1352/2008.113:356-368

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10692

Menting, A. T. A., de Castro, B. O., Wijngaards-de Meij, L. D. N. V., & Matthys, W. (2014). A trial of parent training for mothers being released from incarceration and their children. Journal of Clinical Child and Adolescent Psychology, 43(3), 381-396. https://doi.org/10.1080/15374416.2013.817310

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10693

Morpeth, L., Blower, S., Tobin, K., Taylor, R. S., Bywater, T., Edwards, R. T., Axford, N., Lehtonen, M., Jones, C., & Berry, V. (2017). The effectiveness of the Incredible Years pre-school parenting programme in the United Kingdom: A pragmatic randomised controlled trial. Child Care in Practice, 23(2), 141-161. https://doi.org/10.1080/13575279.2016.1264366

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10697

Patterson, J., Barlow, J., Mockford, C., Klimes, I., Pyper, C., & Stewart-Brown, S. (2002). Improving mental health through parenting programmes: Block randomised controlled trial. Archives of Disease in Childhood, 87(6), 472-477. http://dx.doi.org/10.1136%2Fadc.87.6.472

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10700

Posthumus, J. A., Raaijmakers, M. A. J., Maassen, G. H., van Engeland, H., & Matthys, W. (2012). Sustained effects of Incredible Years as a preventive intervention in preschool children with conduct problems. Journal of Abnormal Child Psychology, 40(4), 487-500. https://doi.org/10.1007/s10802-011-9580-9

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10701

Reedtz, C., Handegård, B. H., & Mørch, W. T. (2011). Promoting positive parenting practices in primary pare: Outcomes and mechanisms of change in a randomized controlled risk reduction trial. Scandinavian Journal of Psychology, 52(2), 131-137. https://doi.org/10.1111/j.1467-9450.2010.00854.x

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10703

Reid, M. J., & Webster-Stratton, C. (2001). The Incredible Years parent, teacher, and child intervention: Targeting multiple areas of risk for a young child with pervasive conduct problems using a flexible, manualized treatment program. Cognitive and Behavioral Practice, 8(4), 377-386. https://doi.org/10.1016/S1077-7229(01)80011-0

Reid, M. J., Webster-Stratton, C., & Baydar, N. (2004). Halting the development of conduct problems in Head Start children: The effects of parent training. Journal of Clinical Child and Adolescent Psychology, 33(2), 279-291. https://doi.org/10.1207/s15374424jccp3302_10

This study is ineligible for review because it does not use an eligible study design (Study Eligibility Criterion 4.1.4).

Study 10704

Sampaio, F., Enebrink, P., Mihalopoulos, C., & Feldman, I. (2016). Cost-effectiveness of four parenting programs and bibliotherapy for parents of children with conduct problems. Journal of Mental Health Policy and Economics, 19(4), 201-212.

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10706

Scott, S., & O'Connor, T. G. (2012). An experimental test of differential susceptibility to parenting among emotionally-dysregulated children in a randomized controlled trial for oppositional behavior. Journal of Child Psychology and Psychiatry, 53(11), 1184-1193. https://doi.org/10.1111/j.1469-7610.2012.02586.x

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10707

Seabra-Santos, M. J., Gaspar, M. F., Azevedo, A. F., Homem, T. C., Guerra, J., Martins, V., Leitāo, S., Pimentel, M., Almeida, M., & Moura-Ramos, M. (2016). Incredible Years parent training: What changes, for whom, how, for how long? Journal of Applied Developmental Psychology, 44, 93-104. https://doi.org/10.1016/j.appdev.2016.04.004

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10709

Silva, I. S., & da Fonseca Gaspar, M. F. (2014). Supporting Portuguese residential child care staff: An exploratory study with the Incredible Years Basic Parent Programme. Psychosocial Intervention, 23(1), 33-41. https://doi.org/10.5093/in2014a4

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10711

Stattin, H., Enebrink, P., Özdemir, M., & Giannotta, F. (2015). A national evaluation of parenting programs in Sweden: The short-term effects using an RCT effectiveness design. Journal of Consulting and Clinical Psychology, 83(6), 1069-1084. https://doi.org/10.1037/a0039328

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10712

Stewart-Brown, S., Patterson, J., Mockford, C., Barlow, J., Klimes, I., & Pyper, C. (2004). Impact of a general practice based group parenting programme: quantitative and qualitative results from a controlled trial at 12 months. Archives of Disease in Childhood, 89(6), 519-525. https://doi.org/10.1111/j.1365-2214.2004.00456_5.x

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10713

Taylor, T. K., Schmidt, F., Pepler, D., & Hodgins, C. (1998). A comparison of eclectic treatment with Webster-Stratton's parents and children series in a children's mental health center: A randomized controlled trial. Behavior Therapy, 29(2), 221-240. https://doi.org/10.1016/S0005-7894(98)80004-X

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).

Study 10716

Webster-Stratton, C., & Herman, K. C. (2008). The impact of parent behavior-management training on child depressive symptoms. Journal of Counseling Psychology, 55(4), 473-484. https://doi.org/10.1037/a0013664

This study is ineligible for review because it is not a study of the program or service under review (Study Eligibility Criterion 4.1.6).