A Type I Hybrid Effectiveness-Implementation Trial of MIO
ConditionSubstance Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBaystate Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Mothering from the Inside Out
BehavioralMothering 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Parental Reflective Functioning
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.
Time frame
Baseline, post treatment (week 21)2
Parental Reflective Functioning
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.
Time frame
Baseline, post treatment (week 21)3
Parenting Stress
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.
Time frame
Baseline, during treatment (week 13), post treatment (week 21), follow-up (week 33)Secondary outcomes
1
Quality of mother-child interaction
The Coding Interactive Behavior (CIB) is a global rating system for analyzing social interactions between two or more partners, in this case, mother and child (videotaped play session with recommended age-appropriate toys). The CIB consists of 33 items (18 relating to the parent, 8 to the child, 5 to the dyad, and 2 focusing on the lead-lag of the interaction) that are rated from 1 (minimal level of behavior) to 5 (maximum level of behavior). Minimum possible score is 33, maximum is 165. A higher score indicates a more positive and adaptive interactive behavior between parent and child.
Time frame
Baseline, follow-up (week 33)2
Substance Use
Toxicology testing is a method to detect the presence of drugs or other chemicals in a person's urine. This testing is already being completed as a normal procedure by the SUD treatment agencies, and the results on study participants only are shared with the study team on a monthly basis.
Time frame
Baseline, monthly during weeks 1-21, post treatment (week 21)3
Substance Use
The Timeline Followback (TLFB) is a method to assess recent drug use. It involves asking clients to retrospectively estimate their drug use 7 days to 2 years prior to the interview date. TLFB data can be scored in various ways to quantify different aspects of substance use - for this study, we are looking at whether participants have recent drug use or not.
Time frame
Baseline, during treatment (week 13), post treatment (week 21), follow-up (week 33)4
Anxiety
The General Anxiety Disorder-7 (GAD-7) is a 7-item screening tool used to assess the severity of generalized anxiety disorder. Each item is rated on a 0-3 scale, with higher scores indicating greater anxiety. Minimum score 0, maximum score 21.
Time frame
Baseline, during treatment (week 13), post treatment (week 21)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Baystate Medical Center
Lead sponsor
Behavioral Health Network
Collaborator
Spectrum Health Systems
Collaborator
Source ClinicalTrials.gov