NCT06163651

Brief Summary

The proposed project seeks to achieve three objectives that will, collectively, evaluate the effectiveness of a one-year version of the Parent-Child Assistance Program (PCAP-1) -a model for a home visitation and case management program for parents who used substances. First, the proposed project aims to estimate the causal impact of PCAP-1 on preventing the need for foster care and promoting reunification. Second, the project will estimate PCAP-1's effectiveness in achieving other program goals: parent recovery, parent's connection with needed comprehensive community resources, and preventing future children from being exposed to drugs and alcohol. Finally, causal evidence of program effectiveness across the prior two objectives would enable PCAP-1 to be rated according to strength of evidence on relevant federal registries (i.e., FFPSA and HOMEVEE). All objectives will be pursued with substantial backing from public and private partners, including the Oklahoma Department of Human Services (OK's Title IV-E agency). This quasi-experimental project will recruit 40 new participants to receive one year of PCAP-1 services. It will use administrative data on participants from the Oklahoma Department of Human Services for the control group. Given that the population PCAP serves are disproportionately poor and low-income and PCAP is designed to be culturally competent and relevant, PCAP-1 harbors the potential to address inequities in child welfare outcomes, substance use disorder treatment services, and child and family well- being by improving outcomes for these families. With a strong backing by state agencies and community partners, the evaluation of PCAP-1 will contribute to a knowledge gap in the field for in-home program models serving a highly vulnerable population with high rates of child welfare involvement and use of foster care.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Jun 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress69%
Jun 2025Sep 2026

First Submitted

Initial submission to the registry

November 20, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
1.5 years until next milestone

Study Start

First participant enrolled

June 23, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

1.3 years

First QC Date

November 20, 2023

Last Update Submit

June 30, 2025

Conditions

Keywords

Parent-Child AssistanceSubstance Use DisorderAddictionsDrug DependenceDrug AbuseAlcohol DependenceAlcohol AbuseAlcoholismRecovery ServicesPCAP

Outcome Measures

Primary Outcomes (3)

  • Proportion of target children not placed in foster care

    The target child is not placed in foster care.

    Measured after 1 year of study participation.

  • Parent acquires or maintains child custody

    The parent has physical custody of the target child.

    Measured after 1 year of study participation.

  • Reduction in costs to state agencies

    Reduced costs to state agencies following PCAP-1 participation.

    Measured after 1 year of study participation.

Secondary Outcomes (5)

  • Proportion of parents who acquire or maintain stable housing

    Measured after 1 year of study participation.

  • Proportion of parents who acquire or maintain employment

    Measured after 1 year of study participation.

  • Proportion of parents who enroll in or complete an educational program

    Measured after 1 year of study participation.

  • Proportion of parents who receive public benefits

    Measured after 1 year of study participation.

  • Proportion of parents with ongoing criminal justice involvement

    Measured after 1 year of study participation.

Study Arms (2)

Treatment Group

EXPERIMENTAL

The treatment group consists of parents who meet our eligibility criteria. Parents in the treatment group will receive PCAP-1 services through the work of highly trained, closely-supervised case managers.

Behavioral: Parent-Child Assistance Program - One-Year Version

Control Group

NO INTERVENTION

The control group consists of parents who meet our eligibility criteria and are part of administrative data from the Oklahoma Department of Human Services in a comparable county to our intervention county, or from prior historical cases within the same county. Parents in the control group can access "services as usual" in the community, but will not receive PCAP in any form.

Interventions

Case managers work closely with parents over the course of one year, meeting them in their own homes when possible, to help them set goals and take advantage of available resources.

Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People over the age of 18
  • Parents with children under the age of 6 living with them
  • Resides within a 50-mile radius of Enid, OK or Oklahoma City, OK (for treatment group)

You may not qualify if:

  • \- Incarcerated at the time of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Remote Worker

Enid, Oklahoma, 73703, United States

RECRUITING

Remote Worker

Oklahoma City, Oklahoma, 73135, United States

RECRUITING

MeSH Terms

Conditions

AlcoholismSubstance-Related DisordersBehavior, Addictive

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Julie Gerlinger, PhD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR
  • Erin Maher, PhD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR
  • Susan Stoner, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Gerlinger, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2023

First Posted

December 11, 2023

Study Start

June 23, 2025

Primary Completion (Estimated)

September 29, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

July 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations