Reducing Alcohol Exposed Pregnancy Risk: EARLY Randomized Controlled Trial
Condition: Alcohol Exposed Pregnancy
Study type: Interventional

Summary: 
      The EARLY Randomized Controlled Trial (RCT) will test the finalized EARLY preventive
      intervention against one comparison and one control condition. Because prevention of
      Alcohol-exposed pregnancy (AEP) will be achieved whether woman change drinking OR
      contraception, the primary endpoints will be rates of risky drinking and ineffective
      contraception at six-month follow-up, in addition to dichotomously defined "successful
      outcome" that will be observed whenever a woman has sufficiently altered one or both of the
      behaviors that placed her at risk of Alcohol-Exposed Pregnancy (AEP). The goal is to identify
      a transferable intervention that effectively reduces behaviors that put women at risk for AEP
      and alcohol-related birth defects including FASD.
    

Detailed description: 
      Drinking women are at risk for alcohol-exposed pregnancy (AEP) if they use contraception
      ineffectively. Binge drinking among women of childbearing age has increased, and risky
      frequent drinking has remained stable in this group of women. Although many women stop or
      reduce their drinking once they realize they are pregnant, pregnancy recognition does not
      occur until the 4th to 6th week of gestation for most women. Serious harm can occur to the
      fetus, especially between weeks 3 and 10 of gestation, if women drink during this period.
      Additionally, increasing numbers of women are drinking during pregnancy, despite public
      health warnings and scientific proof that alcohol is a teratogen. Although many women are
      aware of Fetal Alcohol Syndrome (FAS), few are aware that even low levels of alcohol exposure
      could lead to alcohol-related neurobehavioral disorders and alcohol-related birth defects
      (ARND, ARBD), now known as Fetal Alcohol Spectrum Disorders (FASD). Intervening before
      conception with women who are at risk for AEP could eliminate some cases of FASD. Women at
      risk are problem drinkers who fail to use contraception effectively, and those with
      ineffective contraception who sometimes drink at risk levels. Intervention could focus on
      postponing pregnancy among problem drinkers, or reducing drinking among women who forgo
      pregnancy prevention, or both.

      Motivational interviewing focusing on the dual behaviors that compose risk for AEP is a
      promising approach. A five session, dual-focused motivational interviewing plus contraception
      counseling intervention was effective for women at risk for AEP who were not seeking
      treatment. Unfortunately, even though such interventions may prove effective, they are
      unlikely to be adopted in community settings due to their length and cost. What is needed is
      a less costly, transportable brief intervention that uses the effective components of these
      longer interventions, but delivers them in a condensed format. A briefer intervention could
      be used with women awaiting services or added to existing therapeutic services, and thus
      could have a larger public health impact on reducing the risk of AEP for women drawn from
      diverse settings. A single-session intervention, Project Balance, has shown evidence of
      efficacy with college women, but will require adaptation for less educated community-based
      women with more severe drinking problems or less contraception use. The next step needed to
      advance this field is to develop and test a less time-intensive intervention that builds on
      effective and theory-based interventions, and to test that intervention in women drawn from
      higher risk settings.

      The purpose of this Stage 1b project is to develop and test the efficacy of a brief,
      theory-based, behavioral intervention among a high-risk community sample of fertile women who
      are at particularly high risk for an alcohol-exposed pregnancy (AEP). Because prevention of
      AEP will be achieved whether woman change drinking OR contraception, the primary endpoints
      will be rates of risky drinking and ineffective contraception at six-month follow-up, in
      addition to dichotomously defined "successful outcome" that will be observed whenever a woman
      has sufficiently altered one or both of the behaviors that placed her at risk of AEP. The
      goal is to identify a transferable intervention that effectively reduces behaviors that put
      women at risk for AEP and alcohol-related birth defects including FASD. The specific aims are
      to:

        1. Develop the "Exploring Alcohol and Contraception Risks that Limit You" (EARLY)
           intervention, refine training methods and materials, and train therapists to deliver the
           intervention accurately.

        2. Develop measures of the internal validity and fidelity of the intervention, and
           establish their psychometric properties.

        3. Test the efficacy of the EARLY intervention against a minimal intervention condition
           that controls for the effects of assessment, time, and attention. Efficacy to retain
           participants, reduce drinking, and increase contraception will be tested in a pilot
           randomized trial of women drawn from the target populations: settings serving problem
           drinkers (outpatient drug and alcohol treatment settings) or women with ineffective
           contraceptive habits (STD and public health clinics)

        4. Develop materials needed for a Stage 2 efficacy trial, including evidence of the
           feasibility and promise of the EARLY intervention, treatment manuals, therapist training
           materials, and a final instrumentation package.

        5. Examine the role of variables other than group assignment (alcohol problem severity,
           psychiatric co-morbidity, drug use/severity, trans-theoretical model variables
           (readiness, stages, and processes of change, self efficacy, and therapeutic alliance) to
           mediate or moderate response, and examine secondary outcomes of the intervention, such
           as changes in readiness.
    

Intervention name(s): Motivational Interviewing plus feedback; Video; Informational Brochure
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Provides an MI + feedback intervention supplemented with video and brochures-based information; Video arm will provide information via documentary video; Informational Brochures are given to participants following baseline assessment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Fetal Alcohol Spectrum Disorders; FASDs; AEP risk; binge drinking; ineffective contraception