Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2015 Nov 10;10(11):e0142495.
doi: 10.1371/journal.pone.0142495. eCollection 2015.

Predictors of Study Attrition in a Randomized Controlled Trial Evaluating a Perinatal Home-Visiting Program with Mothers with Psychosocial Vulnerabilities

Stéphanie Foulon  1 , Tim Greacen  2 , Blandine Pasquet  3 , Romain Dugravier  4   5 , Thomas Saïas  2   6   7 , Nicole Guedeney  8 , Antoine Guedeney  4   5 , Florence Tubach  3   9   10 ; CAPEDP Study Group
Collaborators, Affiliations
Randomized Controlled Trial

Predictors of Study Attrition in a Randomized Controlled Trial Evaluating a Perinatal Home-Visiting Program with Mothers with Psychosocial Vulnerabilities

Stéphanie Foulon et al. PLoS One. .

Abstract

Objective: Randomised controlled trials evaluating perinatal home-visiting programs are frequently confronted with the problem of high attrition rates. The aim of the present study is to identify predictors of study attrition in a trial evaluating a perinatal home-visiting program in France.

Materials and methods: CAPEDP is a French randomized trial comparing a perinatal home-visiting program using psychologists versus usual care (N = 440). The first assessment was at inclusion into the trial at the 27th week of pregnancy and the final assessment when the child reached the age of two. Attrition rates were calculated at 3 and 24 months postpartum. Stepwise logistic regression was used to identify predictors of early (between inclusion and 3 months postpartum) and later (between 3 and 24 months postpartum) attrition among social, psychological and parenting factors.

Results: Attrition rates were 17% and 63% at 3 and 24 months respectively. At 24 months, there was significantly more attrition in the control arm (70.6%) compared to the intervention arm (55.2%). Five independent predictors of early attrition were identified: having already had an abortion; having greater attachment insecurity as measured with the Vulnerable Attachment Style Questionnaire (VASQ); having lower global severity of psychiatric symptoms as assessed with the Symptom Check-List (SCL-90) at inclusion, being neither currently employed nor studying; and declaring no tobacco consumption during pregnancy. Being randomized into the control arm, having undergone early parental loss before age 11 and having lower global severity of psychiatric symptoms (SCL-90) at 3 months postpartum were the only variables associated with later attrition.

Conclusion: This study provides key information for identifying mothers who may require specific support to avoid study attrition in trials evaluating a home-visiting program.

PubMed Disclaimer

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Attrition from assessment procedures after the first prenatal assessment (T1, at the 27th week of pregnancy), when the child was 3 months old (T2) and at the child’s second birthday (T6, final assessment).
* No data were collected for women who dropped out between randomization and T1 apart from eligibility criteria.
See this image and copyright information in PMC

References

    1. Jadad AR, Enkin MW. Bias in Randomized Controlled Trials Randomized Controlled Trials: Questions, Answers, and Musings, Second Edition Oxford, Uk: Blackwell Publishing Ltd; 2008. pp. 29–47.
    1. Blumenthal DS, Sung J, Coates R, Williams J, Liff J. Recruitment and retention of subjects for a longitudinal cancer prevention study in an inner-city black community. Health Serv Res. 1995;30: 197–205. - PMC - PubMed
    1. Barnett J, Aguilar S, Brittner M, Bonuck K. Recruiting and retaining low-income, multi-ethnic women into randomized controlled trials: successful strategies and staffing. Contemp Clin Trials. 2012;33: 925–932. 10.1016/j.cct.2012.06.005 - DOI - PMC - PubMed
    1. Katz KS, El-Mohandes PA, Johnson DM, Jarrett PM, Rose A, Cober M. Retention of low income mothers in a parenting intervention study. J Community Health. 2001;26: 203–218. - PubMed
    1. Armstrong KL, Fraser JA, Dadds MR, Morris J. Promoting secure attachment, maternal mood and child health in a vulnerable population: a randomized controlled trial. J Paediatr Child Health. 2000;36: 555–562. - PubMed

Publication types