Effectiveness of Repeated MOTivational InterVention to Reduce Ethanol Intake During prEgnancy
Phase: NA
Conditions: Alcohol Abuse in Pregnancy
Sponsor: Fundació Sant Joan de Déu

 
 
 
 
 
Effectiveness of repeated MOTivational InterVention to reduce ethanol in-
take during prEgnancy 
 
PROTOCOL FOR A CLUSTER RANDOMIZED CONTROLLED TRIAL 
Paz Ahumada  
Antoni Gual 
Oscar García-Algar 
Elisenda Eixarch 
María Dolores Gómez-Roig 
Hospital Sant Joan de Déu/ University of Barcelona 
 
 
Study Number: PI17/0010 
PIC-20-18 
 
November 29th, 2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study design: 
 
This is a collaborative study developed by different health and research institutions. The group is 
composed by BCNatal (Barcelona Center for Maternal Fetal and Neonatal Medicine, Hospital Sant Joan de 
Déu), Grupo de investigación Infancia y Entorno (GRIE), Psychiatry Service of Hospital Clinic de Barcelona 
and the Health Department of Catalunya and ASSIR (Centre d’Atenció a la Salut Sexual I Reproductiva) of 
Baix Llobregat.  
 
This is a cluster randomized simple masking controlled trial evaluating the effectiveness of repeated 
motivational interview (MI) during pregnancy on prevalence of ethanol intake, together with its effects 
on offspring neurodevelopment. 
 
Data will be collected by the study-site manager and stored in an electronic data-capture database. The 
coordinator of the study and the statistician will witness the accuracy of the data at the beginning, middle, 
and end of the study (on-site audit). Data will be captured in a paper form basis and then captured into 
the electronic database. 
 
Participants 
 
Inclusion criteria: Maternal age at recruitment at least 18 years old, speak Spanish fluently, women 
controlling their pregnancy in Baix Llobregat Center, who will attend their delivery in Hospital Sant Joan 
de Déu and Parc Sanitari Sant Joan de Déu, viable singleton and non-malformed fetus, coursing first 
trimester of gestation.  
Exclusion criteria: Women not willing to participate in the study, multiple gestations, perinatal infections, 
fetal anomalies including chromosomal abnormalities or structural malformations detected by 
ultrasound, uncontrolled or/and severe maternal chronic disease, language barriers, impossibility to 
obtain the sample (hair length shorter than 9 centimeters and/or discolored hair), and premature rupture 
of membranes.  
 
Interventions and procedures 
 
For the experimental group, the intervention consists in a MI program during prenatal care visits. MI  will 
be received at least one time each trimester of pregnancy. 
For the control group, usual prenatal care attention will be given, but they will be directly asked sign a 
consent form.  
 
Intervention: Motivational interview  
 
The MI is integrated in a structure theoretical mark. This method is a person-centered counseling style 
that increases the intrinsic motivation of the patient to behavioral changes through spirit, acceptance, 
compassion and evocation. Furthermore, it is a low-cost methodology, and any professional or individual 
could have been capacitated. Since the motivational interview is a good cost benefit intervention, it is a 
potential and suitable tool to implement in a healthcare public program.  
Professionals whose attend prenatal care visits at centers allocated to give MI will receive previous 
capacitation (15 hours) dictated by a multidisciplinary expert group who are dedicated several years to 
MI training and addiction disabilities. This training group is composed by a psyquiatrist and a psychologist 
from Addictions Unit of Psychatry Department of Clínic Hospital of Barcelona 
 
 
 
 
 

Prenatal procedures:  
 
All participants will be followed-up during the pregnancy applying following procedures:  
 
- 
Questionnaires to evaluate sociodemographic, health and habits background. This questionnaire 
will be answered during the first trimester of pregnancy.  
- 
SCL-90 (Symptom Checklist): In order to evaluate mental health.  This questionnaire will be filled 
during the first trimester of pregnancy.  
- 
AUDIT-C (Assessment of the Alcohol use disorders identification test): To evaluate ethanol intake. 
This questionnaire will be filled during first trimester of pregnancy and also up to 7 days after 
delivery. 
- 
Fetal neurosonography: To evaluate fetal neurodevelopment and brain structure at 28 and 32 
weeks of gestation through transabdominal and transvaginal exploration using a General Electric 
Voluson E10 sonograph (GE Medical Systems, Zipf, Austria). 
- 
Biological samples: Samples will be collected at the moment of delivery to obtain to different 
biomarkers :  
o 
Ethylglucuronide (EtG) on mother`s hair: In order to evaluate chronic ethanol intake.  
o 
Phosphatidilethanol (PEtH) on dried cordblood spot: In order to evaluate ethanol intake 
during last 3 weeks prior delivery. 
 
 
 
Postnatal procedures: 
 
After both groups (the experimental and control) have delivery, a postnatal follow-up to participants 
(mothers and children) will be given:   
 
- 
Edinburgh postnatal depression scale (EPDS): This scale evaluates the presence of post-natal de-
pression or anxiety. This questionnaire will be performed to mothers at 6 months from delivery.  
- 
ASQ-3 (Ages and Stages Questionnaires): This parent-report questionnaire could be applied since 
first month until 5 years and a half of life. It includes 30 questions organized in 5 areas of develop 
(communication, gross motor, fine motor, problems-solving and adaptative skills).  It will appli-
cate at 6 and 12 months of age.   
- 
Infant Behavior Questionnaire Revised (IBQ-R): This questionnaire is a parent-report measure of 
infant temperament. It will performed at 12 months from delivery.  
- 
Bayley- III test: This test evaluate mental and motor development and also children behavior 
between 1 month to 42 months of age.  It will be performed at 18 months of age.  
- 
Canadian Guidelines for Diagnosis of FASD: It will be evaluated by a pediatrician at 18 months of 
age regarding the diagnostic criteria of FAS and FASD of Canadian Guidelines. 
 
 
Sample size 
 
Assuming a prevalence of ethanol consumption in our environment of at least 40% in the control group 
and about 25% (or less) in the intervention group. Thus, about 240 of prenatally exposed children will be 
followed up in their postnatal period. According to previous experience cohort studies, we may assume a 
maximum of 30% of loss during their ambulatory control. Regarding this estimate, 168 children will 
complete their follow up. This sample size can ensure a 90% of potency to detect differences of prevalence 
between both groups, with a signification of 5%.  
Values were corrected regarding number of clusters (n= 8) and intraclass correlation coefficient. Intraclass 
correlation coefficient was estimated regarding the prevalence of ethanol intake among groups. 
 
 

Randomization and intervention 
 
Under a sequential rollout, 8 clusters (primary care centers from a geographic location of Barcelona; Baix 
Llobregat) were randomly allocated according to a random number generator with a fixed seed, using R 
Core Team (2018). R: A language and environment for statistical computing. R Foundation for Statistical 
Computing, Vienna, Austria. URL https://www.R-project.org/, to incorporate a MI program into existing 
prenatal care visits (intervention group) or usual intervention (control group). The allocation was 
performed by a statician. Midwives from centers allocated to perform MI were trained by an expert team. 
Participants enrolment was performed by midwives of both groups (interventional and control group). 
This is a simple masking study, it means that participants will not aware of the allocation and intervention.  
 
 
Outcomes 
 
The primary outcome of the study is to demonstrate the effectiveness of repetitive MI to reduce alcohol 
intake. This will be measured by the presence of ethanol intake biomarkers (EtG in mother’s hair and Peth 
in cordblood). 
 
 
Statistical analysis 
 
Analysis will be conducted by intention-to-treat. Missing data for the main outcome will be handled by 
complete data analysis because women without an answer on the main outcome will be excluded. All 
analyses will be divided by groups (control vs experimental group). Continuous data will be assessed for 
normality using the Kolmogorov-Smirnoff test. Normally distributed variables will be compared among 
groups using t-test and expressed as mean and standard deviation (SD), while not normally distributed 
variables will be compared using the Mann-Whitney-U test and expressed as medians and interquartile 
range (IQR). Quantitative variables will be compared using X2 test and expressed as counts (n) and pro-
portions (%).For categorical variables Fisher exact test or Chi-squared test are used. Regarding demo-
graphic data (age, sex, body mass index (BMI), etc.); continuous variables will be presented as mean and 
SD, or median and IQR, according to their distribution, and categorical variables as percentages (%). 
 
For the main outcome, differences in prevalence of ethanol intake between groups will be analyzed using 
absolute risk increase defined as the incidence of the outcome in the experimental group minus the inci-
dence in the control group. The absolute risk increase will be depicted in a forest plot. A multivariate 
logistic regression will be performed to determine the Odds Ratio for ethanol intake adjusting by demo-
graphic characteristics. Data will be analyzed using R Core Team (2018). R: A language and environment 
for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. URL https://www.R-
project.org/ and GraphPad Prism version 8.1.2, GraphPad Software, San Diego, California USA, 
www.graphpad.com.