Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04675099
Other study ID # BH-20-132
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 18, 2020
Est. completion date May 2024

Study information

Verified date May 2023
Source Baystate Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This purpose of this study is to use the existing infrastructure and therapeutic relationships developed by Early Intervention, a national system of child development programs, to make an evidence-based intervention for parents with substance use disorder, Mothering from the Inside Out, more readily accessible to postpartum women with substance use disorder. This study will assess the feasibility, acceptability, and preliminary outcomes of the intervention in a pilot randomized controlled trial. We will also identify key implementation domains that impact successful delivery. We hypothesize that the intervention will be feasible and acceptable to the study participants.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date May 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - English speaking - 18 years of age or older - Mother to an index child between birth and 2 years old at the time of estimated start of intervention delivery - Engaged in formal recovery supports (including but not limited to: Recovery Coaches, support groups specific to people in recovery, medication assisted treatment) at time of enrollment for a minimum 3 months - Willing to receive parenting supports for the index child through EI - Geographically based within the catchment area of participating EI programs Exclusion Criteria: - Severe mental health problems (suicidal, homicidal, psychosis episodes within the past year) - Significant cognitive impairment (unable to give informed consent) - Has an index child that has complex medical problems that significantly impact the child's ability to interact with the parent (e.g. blindness, deafness, severe weakness, or paralysis)

Study Design


Intervention

Behavioral:
pCARE
"Mothering from the Inside Out" is an evidence-based intervention delivered in substance use treatment settings that helps mothers with substance use disorders foster parent-child attachment, cope with stressful parenting situations, and promote their child's healthy development. This 3 month counseling intervention both improves parent-child attachment and decreases rates of drug relapse among mothers. The proposed mechanism of action targeted by the intervention is a change in parental reflective functioning, defined as the capacity to recognize and make sense of mental states (especially emotional states) and understand how they influence behavior and relationships.
Other:
Standard Early Intervention services
The state of Massachusetts provides voluntary early childhood development services to substance-exposed infants through a system of Early Intervention programs. These programs offer coordinated services to all infants and toddlers with disabilities and those at risk for developmental delays in homes and child centers beginning at birth.

Locations

Country Name City State
United States Baystate Medical Center Springfield Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Baystate Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Changes in psychiatric symptoms according to the Brief Symptom Index (BSI) The Brief Symptom Index (BSI) is a 53-item measure of psychiatric symptoms scored on a 5-point Likert scale (Cronbach's alpha = .97). 0, 1, 2, 3, and 6 months
Other Changes in depressive symptoms according to the Patient Health Questionnaire-9 (PHQ-9) The Patient Health Questionnaire-9 (PHQ-9) is a widely used 9-item questionnaire rated on a 4-point scale with good psychometric properties including high internal consistency and construct validity. 0, 1, 2, 3, and 6 months
Other Changes in substance use behavior according to the Addiction and Child Welfare Questionnaire (ACWQ) The Addiction and Child Welfare Questionnaire (ACWQ) assesses past substance use and involvement with child welfare systems with yes or no questions as well as frequency on a 4- or 5- point scale. 0, 1, 2, 3, and 6 months
Other Changes in parenting stress according to the Parenting Stress Index (PSI) The Parenting Stress Index - Short Form (PSI) is a validated instrument assessing parenting stress (Cronbach's alpha = 0.93, test-retest coefficient = .96). 0, 1, 2, 3, and 6 months
Other Child development using the Batelle Developmental Inventory Batelle Developmental Inventory contains data collected as part of Early Intervention assessments per the Early Intervention evaluation schedule. All assessments collected during the enrollment period. At baseline
Primary Recruitment and enrollment The number of mothers referred, approached, and enrolled in the study Through study completion up to 3 months
Primary Number of Early Intervention services received All Early Intervention services received by mothers and their child(ren) Through intervention period, an average of 6 months
Primary The duration of intervention sessions Session duration in minutes Through intervention period, an average of 6 months
Primary The number of intervention sessions completed by mothers The total number of sessions completed Through intervention period, an average of 6 months
Primary Mothers' perceived barriers and facilitators to intervention delivery Qualitative perceptions of intervention logistics Through intervention period, an average of 6 months
Primary The number of supervision sessions completed by providers The total number of sessions completed Through intervention period for each mother participant, an average of 6 months
Primary Early Intervention and additional services received by mothers after intervention period Services received qualitatively listed by mothers Post-intervention up to 3 months
Primary Retention of study participants Time to loss of follow-up and perceived reason for discontinuation Through study completion up to 3 months
Primary Qualitative perceptions of intervention sessions from mothers Open-ended feedback of intervention sessions Through intervention period, an average of 6 months
Primary Qualitative perceptions of intervention sessions from Early Intervention providers Open-ended feedback of intervention sessions Through intervention period for each mother participant, an average of 6 months
Primary Qualitative perceptions of intervention sessions from Early Intervention providers after intervention period Open-ended feedback via a 30-minute interview Post-intervention for each mother participant up to 3 months
Primary Qualitative perceptions of intervention sessions from mothers after intervention period Open-ended feedback via a 30-minute interview 3 months after the completion of the intervention
Primary Adherence of providers to the intervention according to a revised 9-point "Mothering from the Inside Out" Adherence Rating Scale The revised Mothering from the Inside Out (MIO) Adherence Rating Scale is a 9-item measure rated on a 3-point scale for frequency of occurrence (never or seldom, sporadically, or consistent) and competence (poorly executed, adequately executed, or well-executed) of intervention delivery. The measure uses intervention session audio- or video- recordings and includes MIO specific fidelity and a measure of therapeutic alliance. Through intervention period for each mother participant, an average of 6 months
Secondary Changes in parental reflective functioning according to the Parent Development Interview (PDI) The Parent Development Interview (PDI) is a 14-item measure of parental reflective functioning in an interview format. Audio-recorded interviews are transcribed and coded on a 9-point Likert scale. 0, 3, and 6 months
Secondary Changes in parent-child interactions according to the Coding Interactive Behavior (CIB) manual Conducting a Free Play Session (a 10 minute video-recorded and coded interaction, face-to-face interaction (infants) or play session) and analyzing using 5-point Likert scale and the Coding Interactive Behavior (CIB) manual, a global coding system with 43 items (22 parent, 16 infant, and 5 dyadic codes). There are six composite scales for: maternal sensitivity, maternal intrusiveness, child involvement, child negative emotionality, dyadic reciprocity and dyadic negative states; and two additional constructs for 12-36 month olds: maternal limit setting and child compliance. 0, 3, 6 months
See also
  Status Clinical Trial Phase
Completed NCT05660434 - Using Aromatherapy in Substance Use Disorder N/A
Active, not recruiting NCT05338268 - Substance Use and Loneliness N/A
Completed NCT04098614 - Barriers to Substance Use Disorder Recovery N/A
Completed NCT03954184 - E-health Implementation (Iowa) N/A
Completed NCT03590106 - Cardiac Surgery Peer Recovery Support Program N/A
Recruiting NCT05118204 - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization Phase 4
Recruiting NCT06273228 - Parenting Young Children in Pediatrics N/A
Recruiting NCT05327504 - Written Exposure Therapy for Veterans With SUD and PTSD N/A
Terminated NCT03517111 - The Impact of a Parenting Intervention on Latino Youth Health Behaviors N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Completed NCT04401215 - Technologically-Augmented Referrals to Mitigate Addiction Consequences N/A
Not yet recruiting NCT06187701 - Co-Active Therapeutic Theatre (Co-ATT) for Dual-Diagnosis Patients N/A
Not yet recruiting NCT06163651 - Evaluating a One-Year Version of the Parent-Child Assistance Program N/A
Recruiting NCT04296604 - Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations N/A
Active, not recruiting NCT02382042 - Intensive Referral Intervention to Improve Substance Use Disorder Treatment Outcomes Among Rural and Highly Rural Veterans N/A
Completed NCT01237366 - Study Targeting Affect Regulation Phase 1/Phase 2
Terminated NCT01356667 - Drum-Assisted Therapy for Native Americans N/A
Completed NCT00708890 - Twelve Step Based Self-help Groups for Substance Related Disorders N/A
Active, not recruiting NCT04048850 - Zepatier in Patients With Substance Use
Recruiting NCT05976646 - Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion Phase 1/Phase 2