Clinical trial NCT04371900: Michigan Contraceptive Access, Research, and Evaluation Study Children: Phase 1
Official title: The Effects of Unintended Pregnancy on Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy
Keywords: contraception
financial access to reproductive health care
unintended pregnancy
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Planned Parenthood Federation of America
name: National Opinion Research Center
First posted: 2020-05-01
Enrollment: 4700
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project builds on the Michigan Contraceptive Access Research and Evaluation Study (M-CARES) to evaluate the long-term effects of mothers' access to free contraceptives and reductions in unintended pregnancies on their children's well-being.

Detailed description: M-CARES uses a randomized control trial design to assess the effects of providing free contraception to mothers on their children born before the intervention. The population subject to intervention is fecund women age 18-35 years at risk of pregnancy and who are clients at Planned Parenthood clinics of Michigan (PPMI), who meet income eligibility criteria, and who would otherwise pay out-of-pocket for services on the day of recruitment (i.e., lacking insurance coverage for received service). The experimental (treatment) condition is a mother's receipt of a voucher providing access to no-cost contraception (up to the price of a name-brand intrauterine device) for 100 days. The control group of mothers receives no voucher. All enrolled women complete a two-part baseline survey and consent to be re-contacted for two follow-up interviews in outgoing years. They also complete a two-part baseline survey and consent to be re-contacted for two follow up interviews in outgoing years. In addition, mothers consent to linkages to their own and their children's administrative data from records held by state and federal health, education, criminal justice, and tax records. Consent covers children already born to women at the time of intervention and children born after intervention. Survey and administrative data provide outcome measures to assess children's well-being and development up to age 18. The study will compare children of mothers who receive the intervention to those who did not.

Eligibility criteria: Inclusion Criteria:

The proposed project will analyze the outcomes of children ages 0 to 17 years old whose mothers enrolled in the Michigan Contraceptive Access, Research and Evaluation Study (M-CARES). M-CARES participation requires that mothers are:

* 18-35 years old
* physically capable (biologically female and fecund) and at risk of having a pregnancy,
* not pregnant at the time of enrollment
* not wishing to become pregnant in the 12 months after enrollment,
* are seeking care at Planned Parenthood of Michigan, and
* face out-of-pocket costs for contraceptives at Planned Parenthood of Michigan.

Primary outcomes:
measure: Number of siblings born after study enrollment (1 year)
timeFrame: Up to 1 year post enrollment
measure: Number of siblings born after study enrollment (3 year)
timeFrame: Up to 3 year post enrollment
measure: Number of siblings born after study enrollment (5 year)
timeFrame: Up to 5 year post enrollment
measure: Standardized achievement test score (1 year)
timeFrame: Up to 1 year post enrollment
measure: Standardized achievement test score (3 year)
timeFrame: Up to 3 year post enrollment
measure: Standardized achievement test score (5 year)
timeFrame: Up to 5 year post enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Planned Parenthood - Ann Arbor-West
state: Michigan
city: Detroit
country: United States
facility: Planned Parenthood - Detroit
state: Michigan
city: Ferndale
country: United States
facility: Planned Parenthood - Ferndale
state: Michigan
city: Grand Rapids
country: United States
facility: Planned Parenthood - Grand Rapids
state: Michigan
city: Kalamazoo
country: United States
facility: Planned Parenthood - Kalamazoo
state: Michigan
city: Lansing
country: United States
facility: Planned Parenthood - Lansing
state: Michigan
city: Livonia
country: United States
facility: Planned Parenthood - Livonia
state: Michigan
city: Traverse City
country: United States
facility: Planned Parenthood - Traverse City
state: Michigan
city: Warren
country: United States
facility: Planned Parenthood - Warren
state: Michigan
Study officials:
References: