Recruiting

Substance Use Treatment

Sponsor:

University of Oklahoma

Code:

NCT04459000

Conditions

Substance Use Disorders

Pregnancy Related

Child Neglect

Eligibility Criteria

Sex: All

Age: 0 - 55

Healthy Volunteers: Not accepted

Interventions

STARS + maternal Attachment Biobehavioral Catchup home visiting model

STARs Only

Study Details

Brief summary:

This study is evaluating a randomized clinical trial and a quasi-experimental observational study combined. Pregnant women with substance abuse issues are referred to the Substance Use Treatment and Recovery (STAR) prenatal clinic, and those who consent to participate in the study will be randomized to the STAR + maternal Attachment Biobehavioral Catchup (mABC) home visiting model or to the STAR only treatment group. Those who opt out of receiving prenatal care at STAR will be recruited as a control group for the QED portion. Those randomized to STAR + mABC will receive additional supports from a licensed therapist, including up to 12 home visits focused on substance exposed babies and positive parenting.

Conditions

Substance Use Disorders

Pregnancy Related

Child Neglect

Study ID

NCT04459000

Start date

Dec 16, 2020

Status verified date

Oct, 2024

Completion date

Sep, 2025

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Pregnant woman with substance abuse issue occurring during pregnancy
  • Eligible for services at the STAR prenatal clinic
  • Speaks/comprehends English

Exclusion Criteria:

  • Unable to read English at 8th grade comprehension level
  • Those outside of Oklahoma City metropolitan area.

Study Design

Enrollment

242 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: STARs Only

Consenting research participant who receive prenatal care services in the STAR clinic, but are not randomized to receive mABC home visiting services.

experimental: STARS + mABC

Consenting research participant who receive prenatal care services in the STAR clinic, and are randomized to receive mABC home visiting services.

no intervention: Control Group/CHOUM Only

These are research participants who were eligible to receive care in the STAR clinic, but did not opt to receive that care.

Interventions

STARS + maternal Attachment Biobehavioral Catchup home visiting model

Mothers receive up to 12 home visits from a licensed therapist focused on attachment and positive parenting in substance exposed babies. This includes 1 prenatal home visit and up to 11 postnatal visits.

STARs Only

Participants receive prenatal care in the STAR clinic (a clinic specifically designed to support mothers with substance abuse who are at risk of losing their children to child welfare at birth).

Primary outcome measure

  • Mother substance use [ Time Frame: Change from baseline to 18 months post birth of child ]
  • Mother contraceptive use [ Time Frame: Change from baseline to 18 months post birth of child ]
  • Mother depressive symptoms [ Time Frame: Change from baseline to 18 months post birth of child ]
  • Child development [ Time Frame: Change from baseline to 18 months post birth of child ]
  • Child development [ Time Frame: Change from baseline to 18 months post birth of child ]
  • Child welfare involvement [ Time Frame: Change from baseline to 18 months post birth of child ]
  • Child welfare reunifications [ Time Frame: Change from baseline to 18 months post birth of child ]

Central Contacts and Locations

Central contacts

Mallory Ford, MS

405-271-8858mallory-ford@ouhsc.edu

Geneva Marshall, MS

4052718858geneva-marshall@ouhsc.edu

Locations

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73117

Contacts

Mallory Ford

405-271-8858mallory-ford@ouhsc.edu

Geneva marshall

405-2718858geneva-marshall@ouhsc.edu

More Information

Sponsor

University of Oklahoma

Last update posted

Oct 31, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2024-10-31.