Testing the Sickle Cell Caregiver Collaboration for Child Development (SCCCD) Intervention

NCT06562439 | Not Yet Recruiting

• 2 other identifiers: SCCCD.SRP.OTK23HL161328
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Sickle cell disease affects 100,000 people and 2,000 newborns each year; 50% of these children have a developmental deficit (\>2 SD) before the age of 3. Early identification of developmental deficit supports timely intervention, but children with sickle cell disease are grossly underdiagnosed and undertreated. The goal of the proposed study is to determine the incidence and severity of developmental deficit at 9, 18 and 30 months of age among children with sickle cell disease and test a 12-month, home-based caregiver intervention with this disproportionately affected population.

Conditions

Sickle Cell Disease

Keywords

child development; developmental delay; parents as teachers; home based intervention

Outcome Measures

Primary Outcomes (4)

• Bayley Scales of Infant Toddler Development-IV

  Child participants will complete up to 3 developmental evaluations with a trained evaluator using the Bayley Scales of Infant Toddler Development-IV. The Bayley assesses development in the domains of cognition, fine and gross motor, and expressive and receptive language. Caregiver questionnaires assess adaptive behavior and social emotional development. Scaled scores range from 1-19, where a score of 10 is average and a higher score indicates better outcome.

  Completed at 9, 18 and 30 months

• Ages and Stages Questionnaire-3

  Caregivers will complete the Ages and Stages Questionnaire-3, which assesses the caregivers perspective of how their child is meeting developmental milestones in the domains of communication, gross motor, fine motor, personal-social and problem solving. Scores range from 0-60, where a higher score indicates a better outcome.

  Completed at 9, 18 and 30 months

• Infant Toddler Activity Card Sort

  Caregivers will complete the Infant Toddler Activity Card Sort (ITACS) to determine activities and routines that are presenting performance or participation challenges for families in the context of their everyday lives.

  Completed at 9, 18 and 30 months

• Behavior Rating Inventory of Executive Function-Preschool

  The Behavior Rating Inventory of Executive Function-Preschool (BRIEF) evaluates executive functioning of toddlers \>2.5 years. Executive functioning is identified as a high risk domain for deficits among individuals with sickle cell disease. Raw scores are converted to t-scores (mean = 50, SD = 10) and scores above 65 are considered clinically significant.

  30 months of age

Secondary Outcomes (3)

• PROMIS Depression (Caregiver)

  Completed at child's 9, 18 and 30 month evaluation.

• Acceptability

  through study completion, an average of 1 year

• Fidelity

  through study completion, an average of 1 year

Study Arms (2)

Developmental Screening

NO INTERVENTION

Participants in this group will complete developmental screening at 9, 18, and 30 months of age.

Developmental Screening + Home-Based Intervention

EXPERIMENTAL

Participants in this group will complete developmental screening at 9, 18 and 30 months of age and monthly home visits with the family using the Parents as Teachers curriculum.

Behavioral: Sickle Cell Collaboration for Child Development

Interventions

Sickle Cell Collaboration for Child Development BEHAVIORAL

The Sickle Cell Collaboration for Child Development (SCCCD) combines the Parents as Teachers curriculum with experienced occupational therapy to help families and children meet their learning and developmental goals.

Developmental Screening + Home-Based Intervention

Eligibility Criteria

• Age: 6 Months - 31 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All sickle cell disease genotypes will be included. Children will be eligible to participate until they reach 31 months of age (1 month over target evaluation).

You may not qualify if:

• Children will be excluded if the child has fragile health, a diagnosis associated with developmental deficit (not sickle cell disease), or the family is not English language proficient -because of limitations in alternative language assessment and intervention delivery.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Related Publications (70)

• Brownson RC, Proctor EK, Luke DA, Baumann AA, Staub M, Brown MT, Johnson M. Building capacity for dissemination and implementation research: one university's experience. Implement Sci. 2017 Aug 16;12(1):104. doi: 10.1186/s13012-017-0634-4.

  PMID: 28814328 BACKGROUND

• Campbell FA, Ramey CT. Effects of early intervention on intellectual and academic achievement: a follow-up study of children from low-income families. Child Dev. 1994 Apr;65(2 Spec No):684-98.

  PMID: 8013248 BACKGROUND

• Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.

  PMID: 16204405 BACKGROUND

• Sandelowski M. Whatever happened to qualitative description? Res Nurs Health. 2000 Aug;23(4):334-40. doi: 10.1002/1098-240x(200008)23:43.0.co;2-g.

  PMID: 10940958 BACKGROUND

• Hennink M, Kaiser BN. Sample sizes for saturation in qualitative research: A systematic review of empirical tests. Soc Sci Med. 2022 Jan;292:114523. doi: 10.1016/j.socscimed.2021.114523. Epub 2021 Nov 2.

  PMID: 34785096 BACKGROUND

• Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.

  PMID: 19664226 BACKGROUND

• Nilsen P, Bernhardsson S. Context matters in implementation science: a scoping review of determinant frameworks that describe contextual determinants for implementation outcomes. BMC Health Serv Res. 2019 Mar 25;19(1):189. doi: 10.1186/s12913-019-4015-3.

  PMID: 30909897 BACKGROUND

• Toomey E, Hardeman W, Hankonen N, Byrne M, McSharry J, Matvienko-Sikar K, Lorencatto F. Focusing on fidelity: narrative review and recommendations for improving intervention fidelity within trials of health behaviour change interventions. Health Psychol Behav Med. 2020 Mar 12;8(1):132-151. doi: 10.1080/21642850.2020.1738935.

  PMID: 34040865 BACKGROUND

• Nelson MC, Cordray DS, Hulleman CS, Darrow CL, Sommer EC. A procedure for assessing intervention fidelity in experiments testing educational and behavioral interventions. J Behav Health Serv Res. 2012 Oct;39(4):374-96. doi: 10.1007/s11414-012-9295-x.

  PMID: 22935907 BACKGROUND

• Gearing RE, El-Bassel N, Ghesquiere A, Baldwin S, Gillies J, Ngeow E. Major ingredients of fidelity: a review and scientific guide to improving quality of intervention research implementation. Clin Psychol Rev. 2011 Feb;31(1):79-88. doi: 10.1016/j.cpr.2010.09.007. Epub 2010 Oct 7.

  PMID: 21130938 BACKGROUND

• Pilkonis PA, Yu L, Dodds NE, Johnston KL, Maihoefer CC, Lawrence SM. Validation of the depression item bank from the Patient-Reported Outcomes Measurement Information System (PROMIS) in a three-month observational study. J Psychiatr Res. 2014 Sep;56:112-9. doi: 10.1016/j.jpsychires.2014.05.010. Epub 2014 May 29.

  PMID: 24931848 BACKGROUND

• 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.

  PMID: 18929686 BACKGROUND

• Pilkonis PA, Choi SW, Reise SP, Stover AM, Riley WT, Cella D; PROMIS Cooperative Group. Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS(R)): depression, anxiety, and anger. Assessment. 2011 Sep;18(3):263-83. doi: 10.1177/1073191111411667. Epub 2011 Jun 21.

  PMID: 21697139 BACKGROUND

• Hoyt CR, L'Hotta AJ, Bauer AH, Chang CH, Varughese TE, Abel RA, King AA. Activity competence among infants and toddlers with developmental disabilities: Rasch analysis of the Infant Toddler Activity Card Sort (ITACS). J Patient Rep Outcomes. 2021 Jan 21;5(1):14. doi: 10.1186/s41687-021-00287-0.

  PMID: 33475869 BACKGROUND

• Schatz J, Roberts CW. Neurobehavioral impact of sickle cell disease in early childhood. J Int Neuropsychol Soc. 2007 Nov;13(6):933-43. doi: 10.1017/S1355617707071196.

  PMID: 17942011 BACKGROUND

• Rydz D, Srour M, Oskoui M, Marget N, Shiller M, Birnbaum R, Majnemer A, Shevell MI. Screening for developmental delay in the setting of a community pediatric clinic: a prospective assessment of parent-report questionnaires. Pediatrics. 2006 Oct;118(4):e1178-86. doi: 10.1542/peds.2006-0466.

  PMID: 17015506 BACKGROUND

• Radecki L, Sand-Loud N, O'Connor KG, Sharp S, Olson LM. Trends in the use of standardized tools for developmental screening in early childhood: 2002-2009. Pediatrics. 2011 Jul;128(1):14-9. doi: 10.1542/peds.2010-2180. Epub 2011 Jun 27.

  PMID: 21708798 BACKGROUND

• Hoyt CR, Chuck AC, Varughese TE, Fisher LC, Manis HE, O'Connor KE, Shen E, Wong AWK, Abel RA, King AA. Psychometric Properties of the Infant Toddler Activity Card Sort. OTJR (Thorofare N J). 2021 Oct;41(4):259-267. doi: 10.1177/15394492211012657. Epub 2021 May 6.

  PMID: 33955289 BACKGROUND

• Hoyt CR, Fernandez JD, Varughese TE, Grandgeorge E, Manis HE, O'Connor KE, Abel RA, King AA. The Infant Toddler Activity Card Sort: A Caregiver Report Measure of Children's Occupational Engagement in Family Activities and Routines. OTJR (Thorofare N J). 2020 Jan;40(1):36-41. doi: 10.1177/1539449219852030. Epub 2019 Jun 4.

  PMID: 31161868 BACKGROUND

• Kind AJH, Buckingham WR. Making Neighborhood-Disadvantage Metrics Accessible - The Neighborhood Atlas. N Engl J Med. 2018 Jun 28;378(26):2456-2458. doi: 10.1056/NEJMp1802313. No abstract available.

  PMID: 29949490 BACKGROUND

• Heitzer AM, Cohen DL, Okhomina VI, Trpchevska A, Potter B, Longoria J, Porter JS, Estepp JH, King A, Henley M, Kang G, Hankins JS. Neurocognitive functioning in preschool children with sickle cell disease. Pediatr Blood Cancer. 2022 Mar;69(3):e29531. doi: 10.1002/pbc.29531. Epub 2021 Dec 31.

  PMID: 34971013 BACKGROUND

• Hogan AM, Pit-ten Cate IM, Vargha-Khadem F, Prengler M, Kirkham FJ. Physiological correlates of intellectual function in children with sickle cell disease: hypoxaemia, hyperaemia and brain infarction. Dev Sci. 2006 Jul;9(4):379-87. doi: 10.1111/j.1467-7687.2006.00503.x.

  PMID: 16764611 BACKGROUND

• Olds DL, Robinson J, O'Brien R, Luckey DW, Pettitt LM, Henderson CR Jr, Ng RK, Sheff KL, Korfmacher J, Hiatt S, Talmi A. Home visiting by paraprofessionals and by nurses: a randomized, controlled trial. Pediatrics. 2002 Sep;110(3):486-96. doi: 10.1542/peds.110.3.486.

  PMID: 12205249 BACKGROUND

• Olds DL, Sadler L, Kitzman H. Programs for parents of infants and toddlers: recent evidence from randomized trials. J Child Psychol Psychiatry. 2007 Mar-Apr;48(3-4):355-91. doi: 10.1111/j.1469-7610.2006.01702.x.

  PMID: 17355402 BACKGROUND

• Wagner MM, Clayton SL. The Parents as Teachers program: results from two demonstrations. Future Child. 1999 Spring-Summer;9(1):91-115, 179-89.

  PMID: 10414012 BACKGROUND

• Bann CM, Wallander JL, Do B, Thorsten V, Pasha O, Biasini FJ, Bellad R, Goudar S, Chomba E, McClure E, Carlo WA. Home-Based Early Intervention and the Influence of Family Resources on Cognitive Development. Pediatrics. 2016 Apr;137(4):e20153766. doi: 10.1542/peds.2015-3766. Epub 2016 Mar 14.

  PMID: 26977079 BACKGROUND

• Neuhauser A, Ramseier E, Schaub S, Burkhardt SCA, Lanfranchi A. MEDIATING ROLE OF MATERNAL SENSITIVITY: ENHANCING LANGUAGE DEVELOPMENT IN AT-RISK FAMILIES. Infant Ment Health J. 2018 Sep;39(5):522-536. doi: 10.1002/imhj.21738. Epub 2018 Aug 8.

  PMID: 30088285 BACKGROUND

• Chaiyachati BH, Gaither JR, Hughes M, Foley-Schain K, Leventhal JM. Preventing child maltreatment: Examination of an established statewide home-visiting program. Child Abuse Negl. 2018 May;79:476-484. doi: 10.1016/j.chiabu.2018.02.019. Epub 2018 Mar 20.

  PMID: 29558714 BACKGROUND

• Yarboi J, Prussien KV, Bemis H, Williams E, Watson KH, McNally C, Henry L, King AA, DeBaun MR, Compas BE. Responsive Parenting Behaviors and Cognitive Function in Children With Sickle Cell Disease. J Pediatr Psychol. 2019 Nov 1;44(10):1234-1243. doi: 10.1093/jpepsy/jsz065.

  PMID: 31579920 BACKGROUND

• Thompson RJ Jr, Gustafson KE, Bonner MJ, Ware RE. Neurocognitive development of young children with sickle cell disease through three years of age. J Pediatr Psychol. 2002 Apr-May;27(3):235-44. doi: 10.1093/jpepsy/27.3.235.

  PMID: 11909931 BACKGROUND

• Varughese TE, Hoyt CR, L'Hotta AJ, Ikemenogo PA, Howdeshell SG, Housten AJ, Abel RA, King AA. Stress and the Home Environment in Caregivers of Children with Sickle Cell. J Pediatr Psychol. 2020 Jun 1;45(5):521-529. doi: 10.1093/jpepsy/jsaa016.

  PMID: 32232470 BACKGROUND

• Committee on Children With Disabilities. Role of the pediatrician in family-centered early intervention services. Pediatrics. 2001 May;107(5):1155-7. doi: 10.1542/peds.107.5.1155.

  PMID: 11331701 BACKGROUND

• Gallegos A, Dudovitz R, Biely C, Chung PJ, Coker TR, Barnert E, Guerrero AD, Szilagyi PG, Nelson BB. Racial Disparities in Developmental Delay Diagnosis and Services Received in Early Childhood. Acad Pediatr. 2021 Sep-Oct;21(7):1230-1238. doi: 10.1016/j.acap.2021.05.008. Epub 2021 May 19.

  PMID: 34020100 BACKGROUND

• Shook LM, Farrell CB, Kalinyak KA, Nelson SC, Hardesty BM, Rampersad AG, Saving KL, Whitten-Shurney WJ, Panepinto JA, Ware RE, Crosby LE. Translating sickle cell guidelines into practice for primary care providers with Project ECHO. Med Educ Online. 2016 Nov 24;21:33616. doi: 10.3402/meo.v21.33616. eCollection 2016.

  PMID: 27887664 BACKGROUND

• Whiteman LN, Haywood C Jr, Lanzkron S, Strouse JJ, Feldman L, Stewart RW. Primary Care Providers' Comfort Levels in Caring for Patients with Sickle Cell Disease. South Med J. 2015 Sep;108(9):531-6. doi: 10.14423/SMJ.0000000000000331.

  PMID: 26332477 BACKGROUND

• Lipkin PH, Macias MM, Baer Chen B, Coury D, Gottschlich EA, Hyman SL, Sisk B, Wolfe A, Levy SE. Trends in Pediatricians' Developmental Screening: 2002-2016. Pediatrics. 2020 Apr;145(4):e20190851. doi: 10.1542/peds.2019-0851. Epub 2020 Mar 2.

  PMID: 32123018 BACKGROUND

• Armstrong FD, Elkin TD, Brown RC, Glass P, Rana S, Casella JF, Kalpatthi RV, Pavlakis S, Mi Z, Wang WC; Baby Hug Investigators. Developmental function in toddlers with sickle cell anemia. Pediatrics. 2013 Feb;131(2):e406-14. doi: 10.1542/peds.2012-0283. Epub 2013 Jan 6.

  PMID: 23296434 BACKGROUND

• Drazen CH, Abel R, Gabir M, Farmer G, King AA. Prevalence of Developmental Delay and Contributing Factors Among Children With Sickle Cell Disease. Pediatr Blood Cancer. 2016 Mar;63(3):504-10. doi: 10.1002/pbc.25838. Epub 2015 Nov 17.

  PMID: 26575319 BACKGROUND

• Yawn BP, Buchanan GR, Afenyi-Annan AN, Ballas SK, Hassell KL, James AH, Jordan L, Lanzkron SM, Lottenberg R, Savage WJ, Tanabe PJ, Ware RE, Murad MH, Goldsmith JC, Ortiz E, Fulwood R, Horton A, John-Sowah J. Management of sickle cell disease: summary of the 2014 evidence-based report by expert panel members. JAMA. 2014 Sep 10;312(10):1033-48. doi: 10.1001/jama.2014.10517.

  PMID: 25203083 BACKGROUND

• Wang WC, Zou P, Hwang SN, Kang G, Ding J, Heitzer AM, Schreiber JE, Helton K, Hankins JS. Effects of hydroxyurea on brain function in children with sickle cell anemia. Pediatr Blood Cancer. 2021 Oct;68(10):e29254. doi: 10.1002/pbc.29254. Epub 2021 Jul 31.

  PMID: 34331507 BACKGROUND

• Miller M, Landsman R, Scott JP, Heffelfinger AK. Fostering equity in education and academic outcomes in children with sickle cell disease. Clin Neuropsychol. 2022 Feb;36(2):245-263. doi: 10.1080/13854046.2021.1945147. Epub 2021 Jul 5.

  PMID: 34218732 BACKGROUND

• Burnes DP, Antle BJ, Williams CC, Cook L. Mothers raising children with sickle cell disease at the intersection of race, gender, and illness stigma. Health Soc Work. 2008 Aug;33(3):211-20. doi: 10.1093/hsw/33.3.211.

  PMID: 18773796 BACKGROUND

• Nelson SC, Hackman HW. Race matters: perceptions of race and racism in a sickle cell center. Pediatr Blood Cancer. 2013 Mar;60(3):451-4. doi: 10.1002/pbc.24361. Epub 2012 Sep 28.

  PMID: 23023789 BACKGROUND

• Constantino JN, Abbacchi AM, Saulnier C, Klaiman C, Mandell DS, Zhang Y, Hawks Z, Bates J, Klin A, Shattuck P, Molholm S, Fitzgerald R, Roux A, Lowe JK, Geschwind DH. Timing of the Diagnosis of Autism in African American Children. Pediatrics. 2020 Sep;146(3):e20193629. doi: 10.1542/peds.2019-3629.

  PMID: 32839243 BACKGROUND

• Schatz J, Schlenz AM, Smith KE, Roberts CW. Predictive validity of developmental screening in young children with sickle cell disease: a longitudinal follow-up study. Dev Med Child Neurol. 2018 May;60(5):520-526. doi: 10.1111/dmcn.13689. Epub 2018 Feb 28.

  PMID: 29488622 BACKGROUND

• Schatz J, McClellan CB, Puffer ES, Johnson K, Roberts CW. Neurodevelopmental screening in toddlers and early preschoolers with sickle cell disease. J Child Neurol. 2008 Jan;23(1):44-50. doi: 10.1177/0883073807307982. Epub 2007 Dec 26.

  PMID: 18160556 BACKGROUND

• Hogan AM, Kirkham FJ, Prengler M, Telfer P, Lane R, Vargha-Khadem F, Haan M. An exploratory study of physiological correlates of neurodevelopmental delay in infants with sickle cell anaemia. Br J Haematol. 2006 Jan;132(1):99-107. doi: 10.1111/j.1365-2141.2005.05828.x.

  PMID: 16371025 BACKGROUND

• Kawadler JM, Clayden JD, Clark CA, Kirkham FJ. Intelligence quotient in paediatric sickle cell disease: a systematic review and meta-analysis. Dev Med Child Neurol. 2016 Jul;58(7):672-9. doi: 10.1111/dmcn.13113. Epub 2016 Mar 31.

  PMID: 27038278 BACKGROUND

• Prussien KV, Jordan LC, DeBaun MR, Compas BE. Cognitive Function in Sickle Cell Disease Across Domains, Cerebral Infarct Status, and the Lifespan: A Meta-Analysis. J Pediatr Psychol. 2019 Sep 1;44(8):948-958. doi: 10.1093/jpepsy/jsz031.

  PMID: 31050352 BACKGROUND

• Damschroder LJ, Reardon CM, Opra Widerquist MA, Lowery J. Conceptualizing outcomes for use with the Consolidated Framework for Implementation Research (CFIR): the CFIR Outcomes Addendum. Implement Sci. 2022 Jan 22;17(1):7. doi: 10.1186/s13012-021-01181-5.

  PMID: 35065675 BACKGROUND

• Davis M, Beidas RS. Refining contextual inquiry to maximize generalizability and accelerate the implementation process. Implement Res Pract. 2021 Mar 17;2:2633489521994941. doi: 10.1177/2633489521994941. eCollection 2021 Jan-Dec.

  PMID: 37089986 BACKGROUND

• Council on Children With Disabilities; Section on Developmental Behavioral Pediatrics; Bright Futures Steering Committee; Medical Home Initiatives for Children With Special Needs Project Advisory Committee. Identifying infants and young children with developmental disorders in the medical home: an algorithm for developmental surveillance and screening. Pediatrics. 2006 Jul;118(1):405-20. doi: 10.1542/peds.2006-1231.

  PMID: 16818591 BACKGROUND

• DeBaun MR, Jordan LC, King AA, Schatz J, Vichinsky E, Fox CK, McKinstry RC, Telfer P, Kraut MA, Daraz L, Kirkham FJ, Murad MH. American Society of Hematology 2020 guidelines for sickle cell disease: prevention, diagnosis, and treatment of cerebrovascular disease in children and adults. Blood Adv. 2020 Apr 28;4(8):1554-1588. doi: 10.1182/bloodadvances.2019001142.

  PMID: 32298430 BACKGROUND

• Proctor EK, Powell BJ, McMillen JC. Implementation strategies: recommendations for specifying and reporting. Implement Sci. 2013 Dec 1;8:139. doi: 10.1186/1748-5908-8-139.

  PMID: 24289295 BACKGROUND

• Hoyt Drazen C, Abel R, Lindsey T, King AA. Development and feasibility of a home-based education model for families of children with sickle cell disease. BMC Public Health. 2014 Feb 5;14:116. doi: 10.1186/1471-2458-14-116.

  PMID: 24499305 BACKGROUND

• Peacock S, Konrad S, Watson E, Nickel D, Muhajarine N. Effectiveness of home visiting programs on child outcomes: a systematic review. BMC Public Health. 2013 Jan 9;13:17. doi: 10.1186/1471-2458-13-17.

  PMID: 23302300 BACKGROUND

• King AA, Rodeghier MJ, Panepinto JA, Strouse JJ, Casella JF, Quinn CT, Dowling MM, Sarnaik SA, Thompson AA, Woods GM, Minniti CP, Redding-Lallinger RC, Kirby-Allen M, Kirkham FJ, McKinstry R, Noetzel MJ, White DA, Kwiatkowski JK, Howard TH, Kalinyak KA, Inusa B, Rhodes MM, Heiny ME, Fuh B, Fixler JM, Gordon MO, DeBaun MR. Silent cerebral infarction, income, and grade retention among students with sickle cell anemia. Am J Hematol. 2014 Oct;89(10):E188-92. doi: 10.1002/ajh.23805. Epub 2014 Aug 4.

  PMID: 25042018 BACKGROUND

• Yarboi J, Compas BE, Brody GH, White D, Rees Patterson J, Ziara K, King A. Association of social-environmental factors with cognitive function in children with sickle cell disease. Child Neuropsychol. 2017 Apr;23(3):343-360. doi: 10.1080/09297049.2015.1111318. Epub 2015 Nov 15.

  PMID: 26568287 BACKGROUND

• Hoyt CR, Varughese TE, Erickson J, Haffner N, Luo L, L'Hotta AJ, Yeager L, King AA. Developmental delay in infants and toddlers with sickle cell disease: a systematic review. Dev Med Child Neurol. 2022 Feb;64(2):168-175. doi: 10.1111/dmcn.15048. Epub 2021 Sep 17.

  PMID: 34535892 BACKGROUND

• Fields ME, Hoyt-Drazen C, Abel R, Rodeghier MJ, Yarboi JM, Compas BE, King AA. A pilot study of parent education intervention improves early childhood development among toddlers with sickle cell disease. Pediatr Blood Cancer. 2016 Dec;63(12):2131-2138. doi: 10.1002/pbc.26164. Epub 2016 Aug 11.

  PMID: 27509845 BACKGROUND

• Varni JW, Panepinto JA. Cognitive functioning, patient health communication, and worry mediate pain predictive effects on health-related quality of life in youth with sickle cell disease. Pediatr Blood Cancer. 2020 Nov;67(11):e28680. doi: 10.1002/pbc.28680. Epub 2020 Aug 29.

  PMID: 32860648 BACKGROUND

• Hardy SJ, Bills SE, Wise SM, Hardy KK. Cognitive Abilities Moderate the Effect of Disease Severity on Health-Related Quality of Life in Pediatric Sickle Cell Disease. J Pediatr Psychol. 2018 Sep 1;43(8):882-894. doi: 10.1093/jpepsy/jsy019.

  PMID: 29659914 BACKGROUND

• Barakat LP, Patterson CA, Daniel LC, Dampier C. Quality of life among adolescents with sickle cell disease: mediation of pain by internalizing symptoms and parenting stress. Health Qual Life Outcomes. 2008 Aug 9;6:60. doi: 10.1186/1477-7525-6-60.

  PMID: 18691422 BACKGROUND

• Sanger M, Jordan L, Pruthi S, Day M, Covert B, Merriweather B, Rodeghier M, DeBaun M, Kassim A. Cognitive deficits are associated with unemployment in adults with sickle cell anemia. J Clin Exp Neuropsychol. 2016 Aug;38(6):661-71. doi: 10.1080/13803395.2016.1149153.

  PMID: 27167865 BACKGROUND

• Aygun B, Parker J, Freeman MB, Stephens AL, Smeltzer MP, Wu S, Hankins JS, Wang WC. Neurocognitive screening with the Brigance preschool screen-II in 3-year-old children with sickle cell disease. Pediatr Blood Cancer. 2011 Apr;56(4):620-4. doi: 10.1002/pbc.22833. Epub 2010 Nov 11.

  PMID: 21298749 BACKGROUND

• Farber MD, Koshy M, Kinney TR. Cooperative Study of Sickle Cell Disease: Demographic and socioeconomic characteristics of patients and families with sickle cell disease. J Chronic Dis. 1985;38(6):495-505. doi: 10.1016/0021-9681(85)90033-5.

  PMID: 4008590 BACKGROUND

• Rees DC, Williams TN, Gladwin MT. Sickle-cell disease. Lancet. 2010 Dec 11;376(9757):2018-31. doi: 10.1016/S0140-6736(10)61029-X. Epub 2010 Dec 3.

  PMID: 21131035 BACKGROUND

• Ohene-Frempong K, Weiner SJ, Sleeper LA, Miller ST, Embury S, Moohr JW, Wethers DL, Pegelow CH, Gill FM. Cerebrovascular accidents in sickle cell disease: rates and risk factors. Blood. 1998 Jan 1;91(1):288-94.

  PMID: 9414296 BACKGROUND

• Piel FB, Steinberg MH, Rees DC. Sickle Cell Disease. N Engl J Med. 2017 Apr 20;376(16):1561-1573. doi: 10.1056/NEJMra1510865. No abstract available.

  PMID: 28423290 BACKGROUND

• Hassell KL. Population estimates of sickle cell disease in the U.S. Am J Prev Med. 2010 Apr;38(4 Suppl):S512-21. doi: 10.1016/j.amepre.2009.12.022.

  PMID: 20331952 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell; Learning Disabilities

Interventions

Child Development

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Human Development; Growth and Development; Physiological Phenomena

Central Study Contacts

Catherine R Hoyt, PhD

CONTACT

314-286-1761; hoytcr@wustl.edu

Tiffany Radar

CONTACT

3142861197; rounsville@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will randomize children to receive developmental screening alone or developmental screening with a home-based intervention.

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 20, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)