TY - JOUR
T1 - Predicting enrollment in two randomized controlled trials of nonpharmacologic interventions for youth with primary mood disorders
AU - Young, Andrea S.
AU - Seidenfeld, Adina M.
AU - Healy, K. Zachary
AU - Arnold, L. Eugene
AU - Fristad, Mary A.
N1 - Funding Information:
This research was supported by grants from the National Institute of Mental Health ( R34 MH090148 and R34 MH85875 ). The authors thank NIMH for the support but acknowledge that findings and conclusions in this manuscript are those of the authors and do not necessarily reflect the opinions of the NIMH. The authors also thank Dr. Helena Kraemer for providing statistical consultation, staff who collected data, the families who participated and OmegaBrite who provided study capsules.
Funding Information:
Dr. Young has received research funding from Psychnostics, LLC. Dr. Arnold has received research funding from Curemark, Forest, Lilly, Neuropharm, Novartis, Noven, Shire, and YoungLiving (as well as NIH and Autism Speaks) and has consulted with or been on advisory boards for Arbor, Gowlings, Neuropharm, Novartis, Noven, Organon, Otsuka, Pfizer, Roche, Seaside Therapeutics, Sigma Tau, Shire, Tris Pharma, and Waypoint and received travel support from Noven. Dr. Fristad receives royalties from Guilford Press, American Psychiatric Press and Child & Family Psychological Services. She has received honoraria from Physicians Postgraduate Press and the American Occupational Therapy Association. Dr. Seidenfeld and Mr. Healy have no financial disclosures to report.
Publisher Copyright:
© 2018 Elsevier B.V.
PY - 2018/8/1
Y1 - 2018/8/1
N2 - Background: As recruitment and retention are often challenging in randomized controlled trials (RCTs), this study sought to identify predictors of participation (i.e., trial enrollment). Method: These analyses identified predictors of enrollment among 119 youth, ages 7–14, with a primary mood disorder, who screened eligible for the Omega-3 and Therapy pilot studies; 95 (79.8%) actually participated in the treatment. Results: Youth who received some form of travel assistance (16.0%) almost uniformly enrolled in the treatment portion of the RCT. Youth who lived further away from the study site (p =.047) or whose primary caregiver never married (p =.01) were less likely to enroll. Of note, socioeconomic status (SES) variables (parent education and child insurance status) did not significantly predict enrollment, suggesting that study incentives or accommodations may have adequately addressed barriers commonly associated with SES. Limitations: Due to the fairly high trial enrollment rate (approximately 80%), there likely was limited power to detect some differences between groups. Generalizability may be limited to youth with a primary mood disorder diagnosis. Conclusions: Despite retaining a large proportion of the youth who screened eligible, participant self-selection is a limitation of any RCT. A silent inclusion criterion of any RCT is willingness to be randomized.
AB - Background: As recruitment and retention are often challenging in randomized controlled trials (RCTs), this study sought to identify predictors of participation (i.e., trial enrollment). Method: These analyses identified predictors of enrollment among 119 youth, ages 7–14, with a primary mood disorder, who screened eligible for the Omega-3 and Therapy pilot studies; 95 (79.8%) actually participated in the treatment. Results: Youth who received some form of travel assistance (16.0%) almost uniformly enrolled in the treatment portion of the RCT. Youth who lived further away from the study site (p =.047) or whose primary caregiver never married (p =.01) were less likely to enroll. Of note, socioeconomic status (SES) variables (parent education and child insurance status) did not significantly predict enrollment, suggesting that study incentives or accommodations may have adequately addressed barriers commonly associated with SES. Limitations: Due to the fairly high trial enrollment rate (approximately 80%), there likely was limited power to detect some differences between groups. Generalizability may be limited to youth with a primary mood disorder diagnosis. Conclusions: Despite retaining a large proportion of the youth who screened eligible, participant self-selection is a limitation of any RCT. A silent inclusion criterion of any RCT is willingness to be randomized.
KW - Adolescents
KW - Children
KW - Mood disorders
KW - Randomized controlled trial
KW - Trial enrollment
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U2 - 10.1016/j.jad.2018.04.024
DO - 10.1016/j.jad.2018.04.024
M3 - Article
C2 - 29674252
AN - SCOPUS:85045546395
VL - 235
SP - 368
EP - 373
JO - Journal of Affective Disorders
JF - Journal of Affective Disorders
SN - 0165-0327
ER -