Substance Use Disorder (SUD)Ohio STARTNCT07278427
Reducing Parental Substance Use and Enhancing Family Resilience Among Rural Families Through Ohio START
A study testing Ohio START (Ohio Sobriety, Treatment, and Reducing Trauma) in people with Substance Use Disorder (SUD) and Rural Health, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorder (SUD), Rural Health, Family Resilience
- What is being tested?
- Ohio START (Ohio Sobriety, Treatment, and Reducing Trauma)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2026to 1 Aug 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 or older
- who score 3 or higher on the substance use screening tool (UNCOPE)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Susan Yoon, PhD, 614-292-3289, yoon.538@osu.edu
Elinam Dellor, PhD, 614-292-3085, dellor.1@osu.edu
About this study
Official title: Reducing Parental Substance Use, Improving Child Health Outcomes, and Enhancing Family Resilience Among Rural Families Through Ohio START (Sobriety, Treatment, and Reducing Trauma)
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?
Read more
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
Read the detailed description
Co-occurring parental substance use disorder (SUD) and child maltreatment are key risk factors associated with poor health outcomes among children and families in rural areas. Importantly, rural communities face geographic, economic, and social challenges that limit their access to SUD treatment services. Ohio Sobriety, Treatment, and Reducing Trauma (Ohio START) is a family-centered child welfare service delivery intervention that builds on cross-system collaboration with behavioral health service organizations to provide timely access to SUD treatment services for parents involved with the child welfare system. Ohio START also supports parents' journey to SUD recovery through family peer mentors -individuals with lived experience in SUD recovery and previous child welfare involvement- who offer intensive recovery support. When Ohio START child welfare caseworkers refer parents to SUD treatment services located within or near the places parents regularly visit (i.e., activity spaces), parents may be more likely to engage in treatment consistently and experience improvements in their health and family well-being. Similarly, when parents actively engage with family peer mentors, who help them connect with treatment and recovery communities, they may experience positive shifts in their activity spaces and social networks. Yet, it remains unclear how access to SUD treatment services within parents' activity spaces and greater engagement with family peer mentors influence child and family health outcomes, especially among low-income families in rural areas. These are important questions that, if answered, could enhance interventions to better serve families in rural communities. Capitalizing on a unique opportunity to leverage the ongoing Ohio START initiative and access child welfare-involved families in rural areas, we seek to collect novel, longitudinal activity space and social networks data from 400 families engaging in Ohio START. The study has three specific aims: (1) to determine whether the overlap between parental activity spaces and child welfare workers' referral networks (i.e., proximity and availability of SUD treatment providers) predicts intermediate (i.e., SUD treatment service use, family resilience) and long-term (i.e., parent substance use, child psychosocial-behavioral health, child maltreatment) family health outcomes; (2) to examine how parents' engagement with family peer mentors is associated with changes in the attributes of parental activity spaces and social networks over time and how these changes, in turn, are associated with family health outcomes; (3) to test whether rurality moderates the effects of SUD treatment referral networks, activity spaces, and social networks on family health outcomes. The proposed project will produce valuable knowledge that can be used to modify START and other family-level intervention efforts to mitigate risks and maximize protection in parents' activity spaces and social networks to enhance family resilience, prevent child maltreatment, and promote child well-being in rural communities.
- Conditions
- Substance Use Disorder (SUD), Rural Health, Family Resilience, Child Maltreatment, Child Well-beiing, Substance Use Recovery
- Being tested
- Ohio START (Ohio Sobriety, Treatment, and Reducing Trauma)
- Keywords
- Substance use disorder, Child abuse and neglect, Rural health, Child welfare services, Low socioeconomic status, Rurality, Longitudinal study, Prospective study, Family resilience, Social network, Activity spaces, Child maltreatment, Parental substance use, Family peer mentors, Social networks, Rural families, Ohio START, Child well-being, Substance use treatment services, Family health
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ohio START (Ohio Sobriety, Treatment, and Reducing Trauma)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Parents receiving Ohio START services | Experimental | 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. Receives: Behavioral: Ohio START (Ohio Sobriety, Treatment, and Reducing Trauma) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: Baseline, 6 months, and 12 months
Secondary outcomes (2)
Substance use disorder (SUD) treatment service use
Parents' SUD treatment service utilization (the number of substance use treatment sessions attended) will be measured using the information (e.g., date of the treatment session attended) that behavioral health service providers enter into the Needs Portal.
Measured: Baseline, 6-months, and 12-months
Family resilience
Family resilience score will be computed using the Family Functioning and Resilience subscale of the Protective Factors Survey (PFS; 5 items). Responses on the five items (e.g., "my family pulls together when things are stressful", "my family is able to solve our problems", "in my family, we talk about problems") will be summed to create the total family resilience score.
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start21 May 2026
- Primary completion29 Feb 2028 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Substance Use Disorder (SUD)Studies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Michigan
- Responsible party
- Principal investigator, Susan Yoon, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278427
- Sponsor's protocol ID
- 1R01HD119145
- Other IDs
- 1R01HD119145-01
- Acronym
- Ohio START
- Status last verified
- Jul 2026
- First submitted
- 2 Dec 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 17446567Seay 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.
PubMed 26827475Norman 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.
PubMed 23209385Kantor 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.
PubMed 15538039Goodman 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.
PubMed 11699809Fortney 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.
PubMed 11449741