Clinical trial NCT04749771: A Scaleable Video Coaching Intervention for Opioid-using Mothers
Official title: A Scaleable Video Coaching Intervention for Opioid-using Mothers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Child Behavior
Parent-Child Relations
Substance Use
Substance Abuse
Keywords: parent training
early adversity
early intervention
manualized intervention
high-risk children
parenting
fMRI
Lead sponsor: University of Oregon
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 180
Sex: ALL
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups. Half of the participants will be randomized into the experimental condition (FIND) while the other half will be randomized into the active control condition (HTP)
Primary purpose: PREVENTION

Brief summary: This study will adapt and evaluate a novel, innovative, and highly scalable parenting intervention that employs video coaching to target responsive parenting, Filming Interactions to Nurture Development (FIND), among women who have been referred to or are in treatment for opioid misuse/addiction.

Detailed description: The overall objective of this study is to conduct a randomized trial with a sample of opioid-using women who are in or have been referred for treatment through outpatient and inpatient services and have a child aged 0-36 months. We will use a longitudinal design with an active control condition to test the central hypothesis that associations between (a) increases in responsive caregiving and (b) subsequent caregiver opioid addiction recovery, psychological well-being, and child developmental and biobehavioral outcomes (secondary targets), will be partially mediated through (c) changes in caregiver executive functioning, reward responsiveness, and parent self-concept. The rationale for this work is that it simultaneously addresses the unmet needs of a large, significantly underserved population and allows for a rigorous test of our conceptual model, which specifies hypothesized underlying mechanisms and differential impact.

Eligibility criteria: Inclusion Criteria:

* Must be an adult (18-50 years of age)
* Must be the biological parent of a child between the ages of 0-48 months of age
* Must have received, or be currently receiving, treatment for a substance use disorder for any DSM-5 class of substance use disorder except caffeine or tobacco. This includes alcohol, cannabis, hallucinogens, inhalants, opioids, sedatives, hypnotics/anxiolytics, and stimulants.
* Must have their child at least two days each week at study entry

Exclusion Criteria:

* Metal implants, metal fragments, pacemakers, or other electronic medical implants
* Claustrophobic
* Weigh \> 550 lbs
* Women who are or think they may be pregnant
* History of neurological disorders
* Left-handed

Primary outcomes:
measure: Incidence of parenting stress via the Parent Stress Index-IV
timeFrame: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
measure: Caregiver's perceived sense of competency in parenting via the Parent Sense of Competency scale (PSOC)
timeFrame: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
measure: Assessment of the caregivers motivation via measurement on the Behavioral Inhibition System and Behavioral Activation System (BIS/BAS) scale
timeFrame: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
measure: Assessment of emotional or behavioral problems in children as assessed by the SDQ-Infant questionnaire
timeFrame: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
measure: Measurement of Opioid Craving via Opioid Craving Scale
timeFrame: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
measure: Self-report of income, occupation and financial strain via the ECHO measure (Income, Occupation, Financial Strain)
timeFrame: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
measure: Measurement of social support via the Social Support Questionnaire
timeFrame: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
measure: Self-report of commitment and support in regards to family members as assessed by the Cohesion subscale of the Family Enviornment Scale
timeFrame: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
measure: Communicative skills assessed via the MacArthur Communicative Development Inventories (MCDI)
timeFrame: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
measure: Observed level of inhibitory control via the Stop Signal Task
timeFrame: Change from baseline at endpoint (3-4 months post-baseline)
measure: Observed Parental Self-Concept
timeFrame: Change from baseline at endpoint (3-4 months post-baseline)
measure: Coded rate of responsive caregiving via conversational turns
timeFrame: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
measure: Assessment of parent's warmth and hostility towards their child through the use of the Iowa Family Interaction Rating Scales
timeFrame: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Secondary outcomes:
measure: Mobile Messaging for Responsive Caregiving (MMRC)
timeFrame: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
measure: Demographic information
timeFrame: Baseline
measure: Incidence of early adversity assessed via the Adverse Childhood Experiences (ACEs)
timeFrame: Baseline
measure: Assessment of mental health domains across psychiatric conditions via the use of the PhenX Broad Psychopathology questionnaire
timeFrame: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
measure: Intervention Fidelity assessed through use of a fidelity criteria rubric
timeFrame: Assessed at the conclusion of the intervention, directly before endpoint (3-4 months post-baseline)
measure: Intervention Dosage as assessed by number of sessions complete
timeFrame: Assessed at the conclusion of the intervention, directly before endpoint (3-4 months post-baseline)
measure: Assessment of unpredictability and fragmentation of early-life environments in infants and children through the use of the Questionnaire of Unpredictability in Childhood (QUIC)
timeFrame: At Baseline
measure: Self-reported substance use and treatment history as assessed by questionnaire modified from PhenX and iOpen
timeFrame: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Other outcomes:
Locations:
city: Eugene
country: United States
facility: University of Oregon
state: Oregon
Study officials:
affiliation: University of Oregon
name: Philip A Fisher, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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