Contraception Behavior Clinical Trial
Official title:
Factors Predicting Ineffective Contraception Use
Unintended pregnancy (UP), defined as a mistimed or unwanted pregnancy, is a significant and
prevalent public health problem, particularly among low-income women. Over half of all
pregnancies are reportedly unintended and UP has been linked to adverse health outcomes in
mothers and their children. Correct and consistent use of effective contraception is the
primary method to prevent UP. Research has shown that low self-esteem and elevated depressive
symptoms increase women's risk for ineffective contraception use and, by extension, for UP.
This project examines the feasibility and possible efficacy of reducing ineffective
contraception using an intervention that addresses depressive symptoms and self concept among
young, low-income, predominantly minority women at risk for UP. Traditional cognitive
behavioral therapy (CBT) is effective in reducing depressive symptoms and improving self
concept; but limited utilization, poor response, and low adherence to CBT is common among
low-income and minority women. A more acceptable method for delivering CBT is needed for the
target population. This project will use peer-specialists to deliver a CBT-based intervention
to women at risk for UP. Because peer specialists are drawn from the same community as the
target population and share some similar life experiences, the intervention may be more
acceptable and effective than one offered by trained professionals.
This project will examine the effectiveness of a 9 week (8-session) peer-specialist led
CBT-based intervention compared to an observational control condition to reduce depressive
symptoms, improve self-esteem, and improve consistent contraceptive use to prevent UP. The
weekly intervention sessions are delivered by telephone by a trained peer specialist. The
study will evaluate the effectiveness of the intervention to improve consistent contraceptive
use (primary outcome) and decrease depressive symptoms and increase self-esteem (secondary
outcomes).
This is a randomized controlled trial with one intervention group (peer-specialist led
telephone-based CBT) and an observation only control group. There will be 3 measurement
periods: baseline (pre-intervention), 10-week follow-up (post-intervention) and 14-week
follow up. The 14-week follow up assesses the primary outcome (consistency of contraception
use) and secondary outcomes (psychological symptoms and self-esteem), whereas the 10-week
follow up assesses mediating variables (sexual self-efficacy, contraceptive self-efficacy,
social support and coping). There is also a 4-week, mid-intervention assessment of outcomes
designed to assess if there is a worsening of symptoms that needs to be addressed (e.g.
referral for spike in depression or emergence of suicidal intent). This midterm evaluation
also allows us to monitor the well-being of the control group, which has significantly less
contact with project staff than the intervention group.
We will recruit 132 sexually active women from health care clinics (e.g., family planning,
OB/GYN), with the aim of retaining at least 92 (46 per condition). Interested women will be
consented and screened for eligibility in a private area of the clinics. They will be
contacted by phone after consent to complete a structured, baseline questionnaire. After the
baseline questionnaire, women will be randomly allocated to study conditions. Women will be
randomized based on the randomization schedule established by the project biostatistician.
Women allocated to the CBT intervention group will be mailed an intervention workbook and
have their first telephone-based intervention session scheduled. The CBT intervention group
will receive 8 telephone-based CBT intervention sessions (over 9 weeks) delivered by peer
specialists. Each session will last up to 30 minutes. The control group will be an
observation only control group (CTL group). They will not receive any intervention. The
post-intervention and 1-month follow up questionnaires will also be collected via structured
telephone interviews. Research staff who are collecting data will be blinded to study
condition.
In addition to monitoring for worsening of psychological symptoms, procedures are in place
for referring participants with worrisome increases in depression (i.e., >14 on the PHQ9) or
suicidal intent to relevant mental health resources, including hospital emergency rooms and
suicide hotlines for persons expressing suicidal intent. Further, the DSMB will be alerted so
that they can monitor whether one condition appears to have an unusually high increase in
symptoms, which might warrant stopping the trial for safety reasons. In addition, the
researchers collecting data and the peer-specialists implementing the intervention will be
engaged in weekly supervision with a clinical psychologist and have access to the study PI at
all times. The project biostatistician will conduct all intention-to-treat (ITT) analyses
using appropriate modern statistical approaches.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05889689 -
Evaluation of an Adolescent Pregnancy Prevention Program; Relationship Smarts+ With Lessons From Mind Matters
|
N/A | |
Withdrawn |
NCT03725358 -
A Cluster-RCT to Increase the Uptake of LARCs Among Adolescent Females and Young Women in Cameroon.
|
N/A | |
Completed |
NCT02234271 -
Plan A Birth Control: Randomized Controlled Trial of a Mobile Health Application for Contraception Information
|
N/A | |
Enrolling by invitation |
NCT05216003 -
Pregnancy at a Time That Is Happy and Healthy for You
|
N/A | |
Not yet recruiting |
NCT03612518 -
An mHealth Trial to Promote the Use of Postpartum Contraception
|
N/A | |
Completed |
NCT04136613 -
Utility of Immediate Post Placental Insertion of Intrauterine Device During Cesarean Delivery
|
N/A | |
Completed |
NCT03366636 -
Project Legacy Impact Evaluation Study
|
N/A | |
Recruiting |
NCT06100679 -
Responsible Engaged and Loving (REAL) Fathers Intervention Evaluation
|
N/A | |
Completed |
NCT03775642 -
Debunking Myths About Contraceptive Safety Among Women in Kingston, Jamaica
|
N/A | |
Completed |
NCT03571932 -
Assessment of Family Planning and Immunization Service Integration in Liberia
|
||
Completed |
NCT03165838 -
Effectiveness of Shortened Time Interval to Postpartum Visit in Improving Postpartum Attendance
|
N/A | |
Completed |
NCT04120376 -
Reducing Adolescent Pregnancy
|
N/A | |
Completed |
NCT03400410 -
Hormonal Contraceptive Health Education for Adolescent Males
|
N/A | |
Not yet recruiting |
NCT05988983 -
The Over The Counter Pill National Study
|
||
Not yet recruiting |
NCT05362019 -
Effects of One-to-one Service on the Continuation and Satisfaction of Contraceptive Use.
|
N/A | |
Completed |
NCT01360216 -
Cluster, Randomized Trial on Long Acting Reversible Contraception (LARC) Education and Training
|
N/A | |
Completed |
NCT03559634 -
Contraception Initiation Feasibility in the Pediatric ED
|
N/A | |
Enrolling by invitation |
NCT05022134 -
Evaluating the Impact of CHOICE-AYA on Contraceptive Use, Continuation and Satisfaction
|
N/A | |
Active, not recruiting |
NCT03733678 -
A Randomized-Controlled Trial to Increase the Uptake of LARCs in Cameroon
|
N/A | |
Recruiting |
NCT06307002 -
Evaluating What's My Method? in Barbados
|
N/A |