NCT07278427

Brief Summary

The goal of this observational study is to learn about the roles played by parental activity spaces and social networks in reducing parental substance use and promoting child and family health outcomes in the context of Ohio START (Sobriety, Treatment, and Reducing Trauma) for families in rural areas. This study will investigate if substance use treatment service referrals and family peer mentoring services provided by Ohio START lead to positive changes in parental activity spaces and social networks, and if these positive changes lead to better child and family outcomes. The main questions it aims to answer are:

  • Does having behavioral health services (referred by Ohio START workers) close to where parents spend their time help with substance use recovery and child health?
  • Does peer mentor support through Ohio START help parents build stronger social connections and family resilience, and does this lead to better long-term family health?
  • Do these associations differ in rural areas compared to urban areas? Participants will:
  • Answer survey questions about their substance use, parenting, child health, and family well-being across three waves (Wave 1: when they enroll in the study, Wave 2: 6-month follow-up, and Wave 3: 12-month follow-up)
  • Share information about places they go regularly (such as work, stores, and healthcare visits)
  • Share information about people in their support network

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
53mo left

Started Feb 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Feb 2026Aug 2030

First Submitted

Initial submission to the registry

December 2, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2028

Expected
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2030

Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

2.1 years

First QC Date

December 2, 2025

Last Update Submit

December 2, 2025

Conditions

Keywords

Substance use disorderChild abuse and neglectRural healthChild welfare servicesLow socioeconomic statusRuralityLongitudinal studyProspective studyFamily resilienceSocial networkActivity spacesChild maltreatmentParental substance useFamily peer mentorsSocial networksRural familiesOhio STARTChild well-beingSubstance use treatment servicesFamily healthThe START model

Outcome Measures

Primary Outcomes (3)

  • Parental substance use severity

    Parental substance use problems will be measured using the Simple Screening Instrument for Alcohol and Other Drugs (SSI-AOD), a 16-item screen that assesses respondents' experiences with substances in the past month and measures the severity of alcohol and other drug problems. In addition, weekly urine drug screening data (tests administered randomly each week) collected from all Ohio START participants will be drawn from the Need Portal and used to objectively assess parental substance use.

    Baseline, 6 months, and 12 months

  • Child psychosocial and behavioral health

    Child psychosocial-behavioral functioning, including emotional symptoms, conduct problems, peer relationships, hyperactivity, prosocial behaviors, and total problems will be assessed using the Strengths and Difficulties Questionnaire (SDQ; 25 items), a well-established brief psychological assessment tool for children 2 to 17 years old. For children ages 2 months to 1 year and 11 months, the Ages \& Stages Questionnaires: Social-Emotional (ASQ:SE) will be used.

    Baseline, 6 months, and 12 months

  • Child maltreatment

    Using SACWIS data, we will assess the number of reports made to child protective services (CPS) and the type of maltreatment (e.g., physical, sexual, emotional abuse, neglect).

    Baseline, 6 months, and 12 months

Secondary Outcomes (2)

  • Substance use disorder (SUD) treatment service use

    Baseline, 6-months, and 12-months

  • Family resilience

    Baseline, 6 months, and 12 months

Study Arms (1)

Rural parents receiving Ohio START services

Parents who have entered the child welfare system due to co-occurring parental substance use and child maltreatment and who are currently enrolled in Ohio START (Ohio Sobriety, Treatment, and Reducing Trauma). The study is conducted in the context of Ohio START, a children-services-led initiative and evidence-informed intervention model currently operating in 57 counties in the state of Ohio. If both parents from the same family receive the Ohio START intervention, both are eligible to participate.

Behavioral: Ohio START (Ohio Sobriety, Treatment, and Reducing Trauma)

Interventions

Ohio START launched in 2017 in response to the opioid epidemic and is led by the Public Children Services Association of Ohio (PASCO). Ohio START integrates child welfare and substance use treatment systems to enhance access to treatment for parents who come into the child welfare system with addictions. Ohio START capitalizes on collaboration between the child welfare system and behavioral health providers in order to reduce parent wait times for treatment for referrals, increase parent engagement and retention in treatment, and enhance coordination of resources and support for parents and children. Another key aspect of START is the use of family peer mentors as a social network intervention. Parents are paired with family peer mentors who, through weekly visits, support participating families and enhance coordination of resources. Family peer mentors are required to have a minimum of a weekly face-to-face visit with parents for 90 days.

Rural parents receiving Ohio START services

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study participants will include parents who have been impacted by the child welfare system due to co-occurring parental substance use and child maltreatment. Specifically, participants are parents of children of any age between birth and 17 years and 11 months (i.e., less than age 18 years of age) and who have participated in the Ohio Sobriety, Treatment, and Reducing Trauma (Ohio START) intervention. The participant will be 18 years 00 months at minimum. We do not limit the higher end of the participant age. The target sample size for the proposed study is N = 400 parents. In the rare instances where multiple primary parents from the same family are documented, we will randomly select one focal parent (e.g., the parent whose birthday is closest to the referral date).

You may qualify if:

  • age 18 or older;
  • currently enrolled in Ohio START;
  • are unemployed or have family income at or below the federal poverty level,
  • designated as the primary parent in the Ohio START case plan.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (6)

  • Young NK, Boles SM, Otero C. Parental substance use disorders and child maltreatment: overlap, gaps, and opportunities. Child Maltreat. 2007 May;12(2):137-49. doi: 10.1177/1077559507300322.

    PMID: 17446567BACKGROUND
  • Seay K. How Many Families in Child Welfare Services Are Affected by Parental Substance Use Disorders? A Common Question that Remains Unanswered. Child Welfare. 2015;94(4):19-51.

    PMID: 26827475BACKGROUND
  • Norman RE, Byambaa M, De R, Butchart A, Scott J, Vos T. The long-term health consequences of child physical abuse, emotional abuse, and neglect: a systematic review and meta-analysis. PLoS Med. 2012;9(11):e1001349. doi: 10.1371/journal.pmed.1001349. Epub 2012 Nov 27.

    PMID: 23209385BACKGROUND
  • Kantor GK, Holt MK, Mebert CJ, Straus MA, Drach KM, Ricci LR, MacAllum CA, Brown W. Development and preliminary psychometric properties of the multidimensional neglectful behavior scale-child report. Child Maltreat. 2004 Nov;9(4):409-28. doi: 10.1177/1077559504269530.

    PMID: 15538039BACKGROUND
  • Goodman R. Psychometric properties of the strengths and difficulties questionnaire. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1337-45. doi: 10.1097/00004583-200111000-00015.

    PMID: 11699809BACKGROUND
  • Fortney J, Booth BM. Access to substance abuse services in rural areas. Recent Dev Alcohol. 2001;15:177-97. doi: 10.1007/978-0-306-47193-3_10. No abstract available.

    PMID: 11449741BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Central Study Contacts

Susan Yoon, PhD

CONTACT

Elinam Dellor, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 2, 2025

First Posted

December 12, 2025

Study Start

February 1, 2026

Primary Completion (Estimated)

February 28, 2028

Study Completion (Estimated)

August 31, 2030

Last Updated

December 12, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Quantitative Ohio START family survey data generated from the study will be de-identified and shared. The dataset will include three waves of longitudinal data collected at six-month intervals (i.e., Wave 1: baseline, Wave 2: 6-month follow-up, Wave 3: 12-month follow-up) to assess parental activity spaces, social networks, parenting attitudes, family protective factors, and child and family health outcomes. All survey data files will be de-identified before they are archived due to the highly personal and identifiable nature of the target population (i.e., parent enrolled in Ohio START and residing in rural communities) and collected information, such as parental activity spaces (i.e., the name, street, cross-street, city, state, and zip code for each location they frequent for home, school, work, medical care, and child care). Thus, we will de-identify data before sharing data to avoid compromising subject privacy.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Data and metadata will be made available on Data Sharing for Demographic Research (DSDR) upon their publication or the end of the performance period, whichever comes first. Data and metadata will be available indefinitely.
Access Criteria
Public use data and metadata will be archived in Data Sharing for Demographic Research (DSDR). DSDR is housed within the Inter-university Consortium for Political and Social Research (ICPSR). Data will be findable by the research community in DSDR, which produces a unique DOI for each dataset. We will include our unique DSDR doi number for each publication's data set in publications so that reviewers and readers can locate our data. Publications will be findable by the research community in PubMed through a unique DOI for each publication.

Locations