NCT07168642 · Baystate Medical Center
A Type I Hybrid Effectiveness-Implementation Trial of MIO
What this study is about
Mothers with substance use disorders face unprecedented stress in their roles as parents working to care for their children while maintaining healthy recovery.
View original scientific description
Mothers with substance use disorders face unprecedented stress in their roles as parents working to care for their children while maintaining healthy recovery. Mothering from the Inside Out (MIO) is the first attachment-based parenting intervention designed specifically for mothers in recovery from substance use disorders that has been shown to have benefit for both mother and child in multiple randomized controlled trials. This project will: (a) test the effectiveness of MIO among women in outpatient treatment under 'real-world' conditions, (b) evaluate implementation in different settings, and (c) assess key implementation factors to support optimal uptake and treatment in future dissemination studies; closing an important science-to-service gap for an underserved population in an effort to support maternal and child health simultaneously.
Interventions
BEHAVIORAL
Mothering from the Inside Out
Mothering from the Inside Out (MIO) is an evidence-based individual psychotherapy designed to help caregivers in recovery build stronger relationships with their children. In MIO, caregivers are helped to build their ability to reflect on their own mental states and how they arose. Often, we find that the thoughts and feelings that drive caregiving behavior are actually triggered by early experiences of being cared for. MIO thus aims to provide a safe, therapeutic space where caregivers' internal experiences are taken seriously and clinicians are genuinely interested, curious, and collaborative. MIO also involves helping caregivers to reflect on the possible mental states underlying their children's behavior. We find that by providing some information about child development through an attachment lens, this can help parents see through their children's eyes and feel less stressed.
Primary outcome measures
Parental Reflective Functioning
Time frame: Baseline, post treatment (week 21)
The Parent Development Interview (PDI) is a semi-structured clinical interview with 19 questions intended to examine parents' representations of their children, themselves as parents, and their relationships with their children. The PDI is coded using an 11-point reflective functioning rating scale (-1 to 9) where higher score indicates higher reflective capacity.
Parental Reflective Functioning
Time frame: Baseline, post treatment (week 21)
The Parental Reflective Functioning Questionnaire (PRFQ) is an 18-item questionnaire assessing caregiver's capacity to reflect upon his/her own internal mental experiences as well as those of the child. Uses a 7-point Likert scale with 1 being "Completely disagree," 4 being "Neutral," and 7 being "Completely agree." Items 11 and 18 are reverse coded. Minimum score is 18, max is 126. High scores on this scale indicate serious distortions in parental reflective functioning.
Parenting Stress
Time frame: Baseline, during treatment (week 13), post treatment (week 21), follow-up (week 33)
The Parenting Stress Index-Short Form (PSI-SF) is a 36-item questionnaire used to assess parenting stress on a 5-point Likert scale. It's a briefer version of the full Parenting Stress Index, designed to be more efficient for clinical and research settings. The PSI-SF measures three key areas: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child, which together contribute to an overall measure of parenting stress, minimum score 36 and maximum 180. Scores at or above the 85th percentile on the Total Stress scale are considered to be borderline clinically significant.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Identifies as a woman
- English-speaking
- Age 18 years or older
- Enrolled in outpatient substance use treatment for a substance use disorder (by DSMV criteria) at one of the four target clinics operated by participating agencies
- Caring for at least one child between 0 and 60 months of age (either as guardian or working towards reunification with regular contact)
Exclusion criteria
- Have severe mental health problems (e.g., actively suicidal, homicidal, psychosis)
- Severely cognitively impaired
- Have psychiatric or substance-related symptoms requiring inpatient hospitalization or ambulatory detoxification
- Unable to speak English
- Have a potential target child who has a severe medical condition that limits their ability to interact with their mother (such as paralysis or severe weakness) Children Subjects Inclusion Criteria:
- Age 5 years or younger
- Are in their biological mother's custody OR are in custody of family with the goal of reunification with their biological mother and have permission from the child's legal guardian to participate in this study Exclusion Criteria: •In child welfare custody and goal is not reunification with biological mother Counselor Subjects Inclusion Criteria:
- Age 21 years or older
- Employed as an addiction counselor at one of the participating agencies in one of the target clinics
- Have a bachelor's degree or higher in psychology, social work, counseling, or a related field
- Have secure administrative approval for a 1-hour per biweekly commitment to supervision and 2-3 hours weekly for MIO delivery
- Do not intend to give notice and are not scheduled for medical or family leave during the study period
- Willing to have counseling and supervision sessions recorded
- Receive a mean score greater than 4 on the Clinical Reflective Functioning Scale
- Are deemed capable to manage the responsibilities of being a counselor in a randomized trial (deliver MIO promptly to participants, compliant with study procedures and assessments, willing to receive supervision) by their supervisors Exclusion Criteria: •None Agency Staff Subjects Inclusion Criteria:
- Employment at a participating agency for at least 3 months
- Willingness to complete questionnaires and participate in a confidential interview or focus group
- Fluency in English Exclusion Criteria: •None
Where
- Springfield, Massachusetts
Collaborators
Behavioral Health Network, Spectrum Health Systems
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations