- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07278427
Reducing Parental Substance Use and Enhancing Family Resilience Among Rural Families Through Ohio START (Ohio START)
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?
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Susan Yoon, PhD
- Phone Number: 614-292-3289
- Email: yoon.538@osu.edu
Study Contact Backup
- Name: Elinam Dellor, PhD
- Phone Number: 614-292-3085
- Email: dellor.1@osu.edu
Study Locations
-
-
Ohio
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Columbus, Ohio, United States, 43210
- Recruiting
- The Ohio State University
-
Contact:
- Susan Yoon, PhD
- Phone Number: 614-292-3289
- Email: yoon.538@osu.edu
-
Contact:
- Elinam Dellor, PhD
- Phone Number: 614-292-3085
- Email: dellor.1@osu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental substance use severity
Time Frame: Baseline, 6 months, and 12 months
|
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
Time Frame: Baseline, 6 months, and 12 months
|
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
Time Frame: Baseline, 6 months, and 12 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Substance use disorder (SUD) treatment service use
Time Frame: Baseline, 6-months, and 12-months
|
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.
|
Baseline, 6-months, and 12-months
|
|
Family resilience
Time Frame: Baseline, 6 months, and 12 months
|
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.
|
Baseline, 6 months, and 12 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Social network
- Prospective study
- Low socioeconomic status
- Substance use disorder
- Rural health
- Social networks
- Longitudinal study
- Family health
- Child maltreatment
- Child abuse and neglect
- Rurality
- Family resilience
- Child welfare services
- Activity spaces
- Parental substance use
- Family peer mentors
- Rural families
- Ohio START
- Child well-being
- Substance use treatment services
- The START model
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01HD119145 (U.S. NIH Grant/Contract)
- 1R01HD119145-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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