Cited by 162Meta-analysis and systematic reviewsStatistical Methods in Clinical TrialsEthics in Clinical Research

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Attrition in Randomized Controlled Trials for Pediatric Chronic Conditions

Karlson, C. W., Rapoff, M. A.·2009·Journal of Pediatric Psychology

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Abstract

OBJECTIVE: To examine attrition variables in randomized controlled trials of cognitive behavioral interventions for children with chronic illnesses. METHODS: We examined attrition rates reported on 40 randomized cognitive behavioral interventions published in six pediatric research journals, during the years 2002-2007. Intervention focus was limited to children with a chronic medical condition, such as asthma, obesity, arthritis, diabetes, cancer, sickle cell disease, and cystic fibrosis. RESULTS: Mean rate of enrollment refusal was 37% (range 0-75%). Mean attrition rate was 20% (range 0-54%) for initial follow-up and 32% (range 0-59%) for extended follow-up. Of the reviewed articles, 40% included a CONSORT diagram. CONCLUSIONS: Strategies that can be used to limit attrition include tailoring recruitment to the study population, providing personalized feedback, maintaining consistent study procedures, providing incentives, and using intensive tracking measures. There is a need for standardized definitions and reporting of attrition rates in randomized cognitive behavioral intervention studies.

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Stevenson, J., Pimperton, H., Kreppner, J., Worsfold, S., Terlektsi, E., Mahon, M., & Kennedy, C. (2017) · Journal of Child Psychology and Psychiatry · doi:10.1111/jcpp.12803 · Cited by 27
“This degree of attrition is relatively low for follow-up studies of longterm paediatric conditions (Karlson & Rapoff, 2009).”
Background
Child-related characteristics predicting subsequent health-related quality of life in 8- to 14-year-old children with and without cerebellar tumors: a prospective longitudinal study
Bull, K., Liossi, C., Culliford, D. J., Peacock, J. L., Kennedy, C., & on behalf of the Children's Cancer and Leukaemia Group (CCLG) (2014) · Neuro-Oncology Practice · doi:10.1093/nop/npu016 · Cited by 22
“Female 16 (43) 23 (66) 19 (50) Mother respondent 35 (95) 32 (91) 33 (87) Single-parent family 8 (22) 3 (9) 5 (13) Only child 9 (25) 3 (9) 4 (11) Parent education None 1 (3) 2 (6) 2 (5) School 14 (38) 5 (14) 7 (18) College 15 (42) 18 (51) 21 (55) University 6 (16) 10 (29) 8 (21) Unknown 1 (3) 0 0 SES prediagnosis Manag…”
Quality of life among parents seeking treatment for their child’s functional abdominal pain
Calvano, C., & Warschburger, P. (2018) · Quality of Life Research · doi:10.1007/s11136-018-1916-2 · Cited by 22
Dropout from Computer-based Interventions for Children and Adolescents with Chronic Health Conditions
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“…conditions found 4 per cent of participants dropped out after consent had been given but before treatment commenced, 6 per cent dropped out during treatment, 20 per cent of participants dropped out before follow-up and 32 per cent did not complete extended follow-up (Karlson and Rapoff, 2009).”
Background
A person‐centred, theory‐based, behavioural intervention programme for improved oral hygiene in adolescents: A randomized clinical field study
Dimenäs, S. L., Jönsson, B., Andersson, J. S., Lundgren, J., Petzold, M., Abrahamsson, I., & Abrahamsson, K. H. (2022) · Journal Of Clinical Periodontology · doi:10.1111/jcpe.13601 · Cited by 19
“Drop-out rates of about 20%–22% were reported in other studies on health behavioural interventions including adolescents with a 6-month follow-up (Karlson & Rapoff, 2009; Džiaugytė et al., 2017).”
Background
Resilience and Diabetes Distress at 3 Months Following Diagnosis Predict A1C Trajectories in Youth With Type 1 Diabetes: An Argument for Early Intervention
Scott, S., O’Donnell, M., Manczak, E. M., Fladeboe, K., ELLISOR, B. M., Rosenberg, A. R., Malik, F. S., & Yi‐Frazier, J. P. (2022) · Journal of Pediatric Psychology · doi:10.1093/jpepsy/jsac046 · Cited by 21
Recruiting and retaining parents in behavioral intervention trials: Strategies to consider
Shneider, C. E., Hilliard, M. E., Monaghan, M. C., Tully, C., Wang, C. H., Sinisterra, M., Jones, J., Levy, W. L., & Streisand, R. M. (2021) · Contemporary Clinical Trials · doi:10.1016/j.cct.2021.106502 · Cited by 20
A Digital Health Program Targeting Physical Activity Among Adolescents With Overweight or Obesity: Open Trial
Cummings, C., Crochiere, R. J., Lansing, A. H., Patel, R., & Stanger, C. (2022) · JMIR Pediatrics and Parenting · doi:10.2196/32420 · Cited by 19
“Intensive, multi-component behavior modification studies for health behavior change have faced challenges in achieving high adolescent adherence and have struggled to maintain adolescent motivation throughout the program [9,35].”
Background
Evaluation of an approach–avoidance training intervention for children and adolescents with obesity: A randomized placebo‐controlled prospective trial
Warschburger, P., Gmeiner, M. S., Morawietz, M., & Rinck, M. (2018) · European Eating Disorders Review · doi:10.1002/erv.2607 · Cited by 21
Small Interventions for Big Change: Brief Strategies for Distress and Self-Management Amongst Youth with Type 1 Diabetes
Barry, S., Wagner, D. V., & Riley, A. R. (2020) · Current Diabetes Reports · doi:10.1007/s11892-020-1290-7 · Cited by 19
A prospective analysis of the long-term impact of the COVID-19 pandemic on well-being and health care among children with a chronic condition and their families: a study protocol of the KICK-COVID study
Warschburger, P., Kamrath, C., Lanzinger, S., Sengler, C., Wiegand, S., Göldel, J. M., Blüher, S., Holl, R. W., & Minden, K. (2023) · BMC Pediatrics · doi:10.1186/s12887-023-03912-7 · Cited by 17
“Since drop-out rates vary between 0 and 54% [96] we aim to include between 300 and 400 parents and about 100 adolescents.”
Background
Factors Influencing Attrition in a Multisite, Randomized, Clinical Trial Following Traumatic Brain Injury in Adolescence
Blaha, R. Z., Arnett, A. B., Kirkwood, M. W., Taylor, H. G., Stancin, T., Brown, T. M., & Wade, S. L. (2014) · Journal of Head Trauma Rehabilitation · doi:10.1097/htr.0000000000000059 · Cited by 18
CBT for Pediatric Migraine: A Qualitative Study of Patient and Parent Experience
Diest, A. M. K. V., Ernst, M. M., Vaughn, L. M., Slater, S. K., & Powers, S. W. (2018) · Headache The Journal of Head and Face Pain · doi:10.1111/head.13285 · Cited by 17
“Being “too busy” has been cited in other pediatric psychology literature as a reason of declining therapy.(9) Thus, minimizing burden by creating a streamlined treatment for pediatric migraine will likely increase accessibility for pediatric migraine sufferers.”
Background
Impact of motivational interviewing on engagement in a parent‐exclusive paediatric obesity intervention: randomized controlled trial of NOURISH+MI
Bean, M. K., Thornton, L. M., Jeffers, A. J., Gow, R. W., & Mazzeo, S. E. (2018) · Pediatric Obesity · doi:10.1111/ijpo.12484 · Cited by 17
“incentives for completing assessments and implementing culturally appropriate treatments are recommended (4,5).”
Background
Pediatric Weight Management Through mHealth Compared to Face-to-Face Care: Cost Analysis of a Randomized Control Trial
Tully, L., Sørensen, J. R., & O’Malley, G. (2021) · JMIR mhealth and uhealth · doi:10.2196/31621 · Cited by 16
“There was a 23% attrition rate for the trial (25/109); however, this is broadly in line with pediatric RCTs [25] and weight management interventions in general [16], where dropouts are common owing to the intensive nature of these interventions.”
Result
Benefits and Barriers to Engaging in a Family Physical Activity Intervention: A Qualitative Analysis of Exit Interviews
Ross, A. B., Quinlan, A., Blanchard, C. M., Naylor, P., Warburton, D. E. R., & Rhodes, R. E. (2022) · Journal of Child and Family Studies · doi:10.1007/s10826-022-02466-z · Cited by 17
Factors Associated with Recruitment and Retention in Randomized Controlled Trials of Behavioral Interventions for Patients with Pediatric Type 1 Diabetes
Herbert, L., Gillespie, C. W., Monaghan, M. C., Holmes, C. S., & Streisand, R. M. (2015) · Journal of Clinical Psychology in Medical Settings · doi:10.1007/s10880-015-9448-1 · Cited by 16
“…recruitment and retention of a diverse sample of participants, many of which have previously been discussed in the literature (Boys et al., 2003; Coday et al., 2005; Germann et al., 2006; Gul & Ali, 2010; Karlson & Rapoff, 2009; Marcellus, 2004; Patel et al., 2003; Probstfield & Frye, 2011).”
Influential
Recruitment and retention of the Hardest-to-Reach families in community-based asthma interventions
Goldman, H., Fagnano, M., Perry, T. T., Weisman, A. R., Drobnica, A., & Halterman, J. S. (2018) · Clinical Trials · doi:10.1177/1740774518793598 · Cited by 14
Recruitment and retention challenges and strategies in randomized controlled trials of psychosocial interventions for children with cancer and their parents: a collective case study
van Driessche, A., Beernaert, K., Deliëns, L., Kars, M. C., Lyon, M. E., Barrera, M. E., Dussel, V., Bidstrup, P. E., Rosenberg, A. R., Akard, T. F., et al. (2023) · European Journal of Pediatrics · doi:10.1007/s00431-023-05139-1 · Cited by 13
“Even when subjects do enroll, retaining them on these studies can be difficult due to the inherent burdens of study-participation; in a review of 40 clinical RCTs for parents and youth living with chronic illness, reported attrition rates were as high as 54% [5].”
Background
Participation and Attrition in a Coping Skills Intervention for Adolescent Girls with Inflammatory Bowel Disease
Reed, B., McCormick, M. L., Lewis, J. D., & Blount, R. L. (2011) · Journal of Clinical Psychology in Medical Settings · doi:10.1007/s10880-011-9269-9 · Cited by 13
Potentially missing data are considerably more frequent than definitely missing data: a methodological survey of 638 randomized controlled trials
Kahale, L. A., Diab, B., Khamis, A. M., Chang, Y., Lopes, L. C., Agarwal, A., Li, L., Mustafa, R. A., Koujanian, S., Waziry, R., et al. (2018) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2018.10.001 · Cited by 13
Sleep intervention for children with asthma and their parents (SKIP Study): a novel web-based shared management pilot study
Sonney, J., Thompson, H. J., Landis, C. A., Pike, K. C., Chen, M. L., Garrison, M. M., & Ward, T. M. (2020) · Journal of Clinical Sleep Medicine · doi:10.5664/jcsm.8374 · Cited by 12
“12,19,22,23,34,35 Goals related to sleep quantity were based on the National Sleep Foundation ’ s age-speci ﬁ c sleep duration recommendations.”
A proposed standardized approach to studying attrition in pediatric weight management
Spence, N. D., Skelton, J. A., & Ball, G. D. C. (2019) · Obesity Research & Clinical Practice · doi:10.1016/j.orcp.2019.11.004 · Cited by 13
Developing an online, searchable database to systematically map and organise current literature on retention research (ORRCA2)
Kearney, A., Ashford, P., Butlin, L., Conway, T., Cragg, W. J., Devane, D., Gardner, H., Gaunt, D., Gillies, K., Harman, N., et al. (2021) · Clinical Trials · doi:10.1177/17407745211053803 · Cited by 12
Health, Wellbeing and Empowerment E-workshops for Mothers of Children with Disabilities: A Non-randomised Comparison Study
Bourke‐Taylor, H. M., Leo, M., & Tirlea, L. (2024) · Journal of Autism and Developmental Disorders · doi:10.1007/s10803-024-06287-5 · Cited by 12
“%) for extended follow-up (Karlson & Rapoff, 2008).”
Participant Experiences in the Environmental Determinants of Diabetes in the Young Study: Common Reasons for Withdrawing
Lernmark, B., Lynch, K. F., Baxter, J., Roth, R., Simell, T. T., SMITH, L. B., Swartling, U., Johnson, S. B., & TEDDY Study Group (2015) · Journal of Diabetes Research · doi:10.1155/2016/2720650 · Cited by 11
“In fact, only 55% percent of pediatric trials report refusal or withdrawal reasons based on a recent literature review [2].”
An Update on the Status of Sponsored Research in Counseling Psychology
Martens, M. P., Herman, K. C., Takamatsu, S. K., Schmidt, L., Herring, T. E., Labuschagne, Z., & McAfee, N. W. (2016) · The Counseling Psychologist · doi:10.1177/0011000015626271 · Cited by 12
“Suggestions for improving attrition rates, such as incentives, staff training, and tracking procedures, all require time, money, and effort (Karlson & Rapoff, 2008).”
Background
Targeting Coping to Improve Surgical Outcomes in Pediatric Patients With Median Arcuate Ligament Syndrome: Feasibility Study
Stiles‐Shields, C., Osos, S., Heilbrun, A., Feldman, E. C. H., Mak, G. Z., Skelly, C. L., & Drossos, T. (2021) · Frontiers in Psychology · doi:10.3389/fpsyg.2021.695435 · Cited by 12
Recruitment and Retention of Participants for an International Type 1 Diabetes Prevention Trial: A Coordinators’ Perspective
Franciscus, M., Nucci, A., Bradley, B. J., Suomalainen, H. A., Greenberg, E., Laforte, D., Kleemola, P., Hyytinen, M., Salonen, M., Martin, M.-J., et al. (2013) · Clinical Trials · doi:10.1177/1740774513510070 · Cited by 14
“To date, the TRIGR study has experienced a lower rate of attrition (14%) than that reported by Karlson and Rapoff [9] (37%) in their review of attrition rates in randomized interventions in children with chronic conditions.”
BackgroundMethodInfluential
Policy solutions to recruiting and retaining minority children in research
Raphael, J. L., Lion, K. C., & Bearer, C. F. (2017) · Pediatric Research · doi:10.1038/pr.2017.119 · Cited by 11
Demographic and Operational Factors Predicting Study Completion in a Multisite Case-Control Study of Preschool Children
Bradley, C., Browne, E. N., Alexander, A. A., Collins, J., Dahm, J. L., DiGuiseppi, C. G., Levy, S. E., Moody, E. J., Schieve, L. A., Windham, G. C., et al. (2017) · American Journal of Epidemiology · doi:10.1093/aje/kwx262 · Cited by 11
Measurement Burst Designs to Improve Precision in Peer Research
Persram, R. J., Panarello, B., Castellanos, M., Astrologo, L., & Bukowski, W. M. (2021) · Cambridge University Press eBooks · doi:10.1017/9781108986038 · Cited by 12
Clinical Trials in Pediatric Autosomal Dominant Polycystic Kidney Disease
Cadnapaphornchai, M. A. (2017) · Frontiers in Pediatrics · doi:10.3389/fped.2017.00053 · Cited by 11
Resilience strengthening in youth with a chronic medical condition: a randomized controlled feasibility trial of a combined app and coaching program
Bischops, A., Sieper, L., Dukart, J., Schaal, N. K., Reinauer, C., Oommen, P. T., Tomoiagă, C. T., David, D., Mayatepek, E., & Meißner, T. (2024) · European Child & Adolescent Psychiatry · doi:10.1007/s00787-024-02395-w · Cited by 10
“In addition, studies often encounter major recruitment difficulties [18, 19].”
Influential
Improving social cognition following theta burst stimulation over the right inferior frontal gyrus in autism spectrum: an 8-week double-blind sham-controlled trial
Ni, H., Chen, Y., Hsieh, M., Wu, C., Chen, R.-S., Juan, C.-H., Li, C., Gau, S. S., & Lin, H. (2024) · Psychological Medicine · doi:10.1017/s0033291724001387 · Cited by 10
“The mean attrition rate in RCTs for chronic pediatric mental health conditions is suggested to be 20% (Karlson & Rapoff, 2009).”
Background
Social determinants of participant recruitment and retention in a prospective cohort study of pediatric mild traumatic brain injury
Wells, J. M., Galarneau, J.-M. F., Minich, N. M., Cohen, D. M., Clinton, K. N., Taylor, H. G., Bigler, E. D., Bacevice, A. M., Mihalov, L. K., Bangert, B. A., et al. (2022) · Frontiers in Neurology · doi:10.3389/fneur.2022.961024 · Cited by 10
“Both homogenous recruitment practices and attrition become a major threat to internal, external, and statistical validity of intervention studies (4, 5).”
Background
Transdiagnostic Sleep and Circadian Intervention in Youth: Long-Term Follow-Up of a Randomized Controlled Trial
Susman, E. S., Patino, E. O., Tiab, S. S., Dong, L., Gumport, N. B., Sarfan, L. D., Hinshaw, S. P., & Harvey, A. G. (2024) · Journal of the American Academy of Child & Adolescent Psychiatry · doi:10.1016/j.jaac.2024.05.001 · Cited by 10
“50 This level of attrition (39”
Motivational interviewing with parents of overweight children: Study design and methods for the NOURISH+MI study
Bean, M. K., Jeffers, A. J., Tully, C., Thornton, L. M., & Mazzeo, S. E. (2014) · Contemporary Clinical Trials · doi:10.1016/j.cct.2014.02.001 · Cited by 10
“Low treatment adherence and high attrition, however, are frequently encountered, particularly when targeting underserved populations, reducing the effectiveness of these interventions [8–10].”
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Intervention Completion Rates among African Americans in a Randomized Effectiveness Trial for Diet and Physical Activity Changes
Halbert, C. H., Bellamy, S. L., Briggs, V., Bowman, M. A., Delmoor, E., Johnson, J. C., Kumanyika, S., Melvin, C. L., Purnell, J., Rogers, R., et al. (2014) · Cancer Epidemiology Biomarkers & Prevention · doi:10.1158/1055-9965.epi-13-1064 · Cited by 10
“The first element of retention is based on the number of participants who received or completed the intervention relative to the total number who were allocated to study arms; this rate is relevant for determining if the intervention’s efficacy is likely to be underestimated (8-10).”
Are disadvantaged children more likely to be excluded from analysis when applying global positioning systems inclusion criteria?
Mavoa, S., Lamb, K. E., O’Sullivan, D., Witten, K., & Smith, M. (2018) · BMC Research Notes · doi:10.1186/s13104-018-3681-2 · Cited by 10
Utilizing Community Engagement Studios to inform patient experience in a multicenter randomized control trial
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Meta-Analyses Proved Inconsistent in How Missing Data Were Handled Across Their Included Primary Trials: A Methodological Survey
Kahale, L. A., Khamis, A. M., Diab, B., Chang, Y., Lopes, L. C., Agarwal, A., Li, L., Mustafa, R. A., Koujanian, S., Waziry, R., et al. (2020) · Clinical Epidemiology · doi:10.2147/clep.s242080 · Cited by 9
Cognitive Behavioral Therapy for Treatment of Pediatric Chronic Migraine
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“, chronically ill children and adolescents, foster children, migration background, adolescent risk behavior, or drug use; [1, 6, 19, 21, 34, 35, 37, 38]) or on the willingness to participate in intervention or prevention programs [10, 13, 16– 18].”
Background
The Efficacy of a Culturally-Adapted Group-based Parent Coaching Program for Autistic Children in China via Telehealth: A Randomized Controlled Trial
Qu, L., Colombi, C., Chen, W., Miller, A. L., Miller, H. L., & Ulrich, D. A. (2024) · Journal of Autism and Developmental Disorders · doi:10.1007/s10803-024-06543-8 · Cited by 12
“With an expected attrition rate of 20% (Karlson & Rapoff, 2008), a total sample of 36 families, with at least 18 participants per group were randomized in our study.”

Authors: Karlson, C. W., & Rapoff, M. A.
Affiliations: University of Kansas (US)
ORCID: Karlson, C. W.
Venue: Journal of Pediatric Psychology
Publisher: Oxford University Press (OUP)
Published: 2008-12-08
Volume: 34
Issue: 7
Pages: 782-793
ISSN: 0146-8693 (ISSN-L)
1465-735X
DOI: 10.1093/jpepsy/jsn122
OpenAlex: W2117776447
Cited by: 162
References: 72
Citations by year: 2026: 5 · 2025: 5 · 2024: 10 · 2023: 15 · 2022: 9 · 2021: 7 · 2020: 10 · 2019: 10 · 2018: 15 · 2017: 10 · 2016: 10 · 2015: 9 · 2014: 15 · 2013: 10 · 2012: 10
FWCI: 4.53
Type: journal article
Language: en
Open access: closed
Locations: Journal of Pediatric Psychology (publishedVersion)
PubMed (publishedVersion)
Topics: Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
Keywords: attrition, randomized controlled trials, pediatric chronic conditions, cognitive-behavioral intervention, children, attrition rates, CONSORT flow diagram, reporting guidelines, recruitment strategies, incentives, asthma, cystic fibrosis, sickle cell disease, diabetes mellitus, obesity, arthritis, childhood cancer
MeSH terms: Analysis of Variance, Child, Chronic Disease, Follow-Up Studies, Humans, Pediatrics, Cognitive Behavioral Therapy, Randomized Controlled Trials as Topic, Patient Selection, Research Subjects

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Attrition in Randomized Controlled Trials for Pediatric Chronic Conditions

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