Research knowledge among the participants in the Treatment for Adolescents with Depression Study (TADS)

Journal of the American Academy of Child and Adolescent Psychiatry

Volumn 46, Issue 12, 2007, Pages 1642-1650

  Vitiello, Benedetto ^a   Kratochvil, Christopher J ^b   Silva, Susan ^c   Curry, John ^c   Reinecke, Mark ^d   Pathak, Sanjeev ^e   Waslick, Bruce ^f   Hughes, Carroll W ^g   Prentice, Ernest D ^b   May, Diane E ^b   March, John S ^c  

^a NATIONAL INSTITUTE OF MENTAL HEALTH   (United States)

^b UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

^c DUKE UNIVERSITY MEDICAL CENTER   (United States)

^d NORTHWESTERN UNIVERSITY   (United States)

^e ASTRAZENECA   (United Kingdom)

^f BAYSTATE MEDICAL CENTER   (United States)

^g Department of Neurological Surgery and Neurology and Neurotherapeutics University of Texas Southwestern Medical Center   (United States)

Author keywords

Depression; Ethics; Treatment

Indexed keywords

FLUOXETINE; PLACEBO;

ADOLESCENT; ARTICLE; CLINICAL TRIAL; COGNITIVE THERAPY; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; FEMALE; HEALTH CARE QUALITY; HUMAN; MAJOR CLINICAL STUDY; MAJOR DEPRESSION; MALE; MEDICAL INFORMATION; MEDICAL RESEARCH; PARENT; PATIENT EDUCATION; PRIORITY JOURNAL; PSYCHOTHERAPY; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD;

EID: 36349003544     PISSN: 08908567     EISSN: None     Source Type: Journal    
DOI: 10.1097/chi.0b013e318153f8c7     Document Type: Article

References (27)

1. American Academy of Pediatrics (1995), Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 95:286-294
2. Burke TM, Abramovitch R, Zlotkin S (2005), Children's understanding of the risk and benefits associated with research. J Med Ethics 31:715-720
3. Flesch R (1948), A new readability yardstick. J Appl Psychol 32:221-233
4. Flory J, Emanuel E (2004), Interventions to improve research participants' understanding in informed consent for research: a systematic review. JAMA 292:1593-1601
5. Geller G, Tambor ES, Bernhardt BA, Fraser G, Wissow LS (2003), Informed consent for enrolling minors in genetic susceptibility research: a qualitative study of at-risk children's and parents' views about children's role in decision-making. J Adolesc Health 32:260-271
6. Harth SC, Thong YH (1995), Parental perceptions and attitudes about informed consent in children research involving children. Soc Sci Med 40:1573-1577
7. Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC (2001), Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet 358:1772-1777
8. Kodish E, Eder M, Noll RB et al. (2004), Communication of randomization in childhood leukemia trials. JAMA 291:470-475
9. Lidz CW, Appelbaum PS (2002), The therapeutic misconception: problems and solutions. Med Care 40(9 suppl):V55-V63
10. March J, Kratochvil C, Clarke G et al. (2004), AACAP 2002 research forum: placebo and alternatives to placebo in randomized controlled trials in pediatric psychopharmacology. J Am Acad Child Adolesc Psychiatry 43:1046-1056
11. Mason SA, Allmark PJ (2000), Obtaining informed consent to neonatal randomised controlled trials: interviews with parents and clinicians in the Euricon study. Lancet 356:2045-2051
12. Ondrusek N, Abramovitch R, Pencharz P, Koren G (1998), Empirical examination of the ability of children to consent to clinical research. J Med Ethics 24:158-165
13. Sugarman J, Lavori PW, Boeger M et al. (2005), Evaluating the quality of informed consent. Clin Trials 2:34-41
14. Susman EJ, Dorn LD, Fletcher JC (1992), Participation in biomedical research: the consent process as viewed by children, adolescents, young adults, and physicians. J Pediatr 121:547-552
15. TADS Team (2005), The Treatment for Adolescents With Depression Study (TADS): demographics and clinical characteristics. J Am Acad Child Adolesc Psychiatry 444:28-40
16. TADS Team (2004), Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression. JAMA 292:807-820
17. TADS Team (2003), The Treatment for Adolescents With Depression Study (TADS): rationale, design, and methods. J Am Acad Child Adolesc Psychiatry 42:531-542
18. Tait AR, Voepel-Lewis T, Malviya S (2003), Do they understand? Parental consent for children participating in clinical anesthesia and surgery research. Anesthesiology 98:603-608
19. U.S. Department of Health and Human Services (2005). Code of Federal Regulations, Title 45, Public Welfare, Part 46: Protection of Human Subjects, Sections 46.101-46.409. Revised June 23, 2005. Available at: http://www.dhhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Accessed December 12, 2006
20. U.S. Food and Drug Administration (2000), International Conference on Harmonization; E11: Clinical investigation of medicinal products in the pediatric population. Fed Reg 65:19777-19781
21. U.S. Food and Drug Administration (1997), International Conference on Harmonization; E6: Good clinical practice: consolidated guideline. Fed Reg 62:25691-25709
22. U.S. Food and Drug Administration (2001), 21CFR Parts 5- and 56. Additional safeguards for children in clinical investigations of FDA-regulated products. Fed Reg 65:20589-20600
23. Vitiello B, Aman MG, Scahill L et al. (2005), Research knowledge among parents of children participating in a randomized clinical trial. J Am Acad Child Adolesc Psychiatry 44:145-149
24. Wagner KD, Martinez M, Joiner T (2006), Youths' and their parents' attitudes and experiences about participation in psychopharmacology treatment research. J Child Adolesc Psychopharmacol 16:298-307
25. Wechsler D (1991), Wechsler Intelligence Scale for Children Manual-III Edition. San Antonio, TX: Psychological Corporation
26. Whittle A, Sha S, Wilfond B, Gensler G, Wendler D (2004), Institutional review board practices regarding assent in pediatric research. Pediatrics 113:1747-1752
27. Wirshing DA, Wirshing WC, Marder SR, Liberman RP, Mintz J (1998), Informed consent: assessment of comprehension. Am J Psychiatry 155:1508-1511