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A Scaleable Video Coaching Intervention for Opioid-using Mothers

Primary Purpose

Child Behavior, Parent-Child Relations, Substance Use

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Filming Interactions to Nurture Development

The Healthy Toddler Program

About this trial

This is an interventional prevention trial for Child Behavior focused on measuring parent training, early adversity, early intervention, manualized intervention, high-risk children, parenting, fMRI

Eligibility Criteria

undefined - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Must be an adult (18 years or older) mother with a child between the ages of 0-36 months
Must be in or have been referred for treatment due to maternal opioid use
Mother must have custody of child at least half-time 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

Sites / Locations

University of OregonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Filming Interactions to Nurture Development (FIND)

The Healthy Toddler Program (HTP)

Arm Description

FIND is a brief video coaching intervention which involves feedback provided by the coach to the caregiver using brief film clips derived from video of caregiver-child interaction. The coaching focuses on showing caregivers instances in which they are engaging in developmentally-supportive interactions during coaching sessions. FIND is delivered over 10 weekly sessions lasting 30-45 minutes. The process begins with an initial session in which the coach provides an overview, records 10-15 minutes of caregiver-child interaction, then introduces the concept of serve and return. The video is edited to show brief clips in which the caregiver is engaged in the first of five specific caregiver-based components of serve and return. The next week, the FIND coach reviews the edited clips in detail with the caregiver. Sessions continue, alternating between filming and coaching sessions until all five components have been covered sequentially.

HTP, the active control intervention, consists of weekly sessions alternating between (a) coaching sessions covering one of five domains of child development (Motor, Cognitive, Language, Play, and Social-Emotional and (b) observation sessions that will include a review of the prior coaching session and an observation and discussion of the caregiver-child interaction. This intervention will consist of 10 sessions each lasting 25-30 minutes. The coach will not engage in any filming or video coaching, but will be able to discuss caregiving concerns. HTP materials are adapted from the Partners for a Healthy Baby curriculum developed by Florida State University's Center for Prevention and Early Intervention Policy.

Outcomes

Primary Outcome Measures

Incidence of parenting stress via the Parent Stress Index-IV

Items are on a 5-point scale ranging from "strongly agree" to "strongly disagree." Higher scores indicated greater parenting stress. The measures includes three subscales and a total score: Parental distress (12 items) sum score ranging between 12-60 Parent-child dysfunctional interaction (12 items) sum score ranging between 12-60 Difficult child (12 items) sum score ranging between 12-60 Total score (36 items) sum score ranging between 36-180

Caregiver's perceived sense of competency in parenting via the Parent Sense of Competency scale (PSOC)

The Parenting Sense of Competence (PSOC) questionnaire is filled out by the caregiver to assess parents' sense of competence and enjoyment of parenting. This is an adapted version of the PSOC (original PSOC has 17 items, Johnston & Mash, 1989), with 18 items and simplified language for lower reading levels. These items are answered on a 4-point scale ranging from "strongly agree" to "strongly disagree." Scoring for some items is reversed so that, for all items, higher scores indicate greater parenting self-esteem. Nine (9) items (#s 2,3,4,5,8,9,13,15 and 17) on the PSOC are reverse coded. Subscales include: Satisfaction: Mean score of 2,3,4,5,9,13,15,17, and 18 (Range = 1-4) Efficacy: Mean score of 1,6,7,8,10,11,14, and 16 (Range = 1-4) Total Score: 18 - 72, scored responses summed

Assessment of the caregivers motivation via measurement on the Behavioral Inhibition System and Behavioral Activation System (BIS/BAS) scale

The BIS/BAS Scale is a 24-item self-report questionnaire designed to measure two motivational systems: the behavioral inhibition system (BIS) and the behavioral activation system (BAS). Participants respond to each item using a 4-point Likert scale. The scale has four subscales. One subscale corresponds to the BIS. Seven items contribute to this score. The remaining three subscales correspond to three components of BAS. BAS Drive measures the motivation to follow one's goals. Four items contribute to this score. BAS Reward Responsiveness measures the sensitivity to pleasant reinforcers in the environment. Four items contribute to this score.

Assessment of emotional or behavioral problems in children as assessed by the SDQ-Infant questionnaire

The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioural screening questionnaire. 25 items are asked on a 3-point scale from not-true to certainly true. Followed by 5 items assessing difficulties with emotions, concentration, behavior or being able to get along with people.

Measurement of Opioid Craving via Opioid Craving Scale

The Opioid Craving Scale is a modification of the Cocaine Craving Scale (Weiss et al., 1995, 1997, 2003) used to measure opioid craving. The scale consists of three items rated on a visual analogue scale from 0-10

Self-report of income, occupation and financial strain via the ECHO measure (Income, Occupation, Financial Strain)

This measure is a 9-item self-report of income, occupation and financial strain.

Measurement of social support via the Social Support Questionnaire

Measures social support, yielding scores for: Perceived number of social supports Satisfaction with social support that is available Questionnaire consists of 27 items with 2-part responses (listing the people they can turn to and rely upon and how satisfied they are with the social supports). Each item is scored based on the number of support persons listed, and the satisfaction scale scored on a scale of 1 to 6 (1 = very satisfied and 6 = very dissatisfied). The overall number and satisfaction scores are summed and divided by 27.

Self-report of commitment and support in regards to family members as assessed by the Cohesion subscale of the Family Enviornment Scale

The Family Environment Scale (FES) is a self-report 90-item instrument developed to assess the social climates of families focusing on the measurement and description of interpersonal relationships among family members on the directions of personal growth and the basic organizational structure of the family. The Cohesion subscale is a 9-item scale intended to measue the degree of commitment and support that family members provide each other. Respondents rate statements on a scale from mostly true to mostly false.

Communicative skills assessed via the MacArthur Communicative Development Inventories (MCDI)

The MacArthur Communicative Development Inventories (MCDI) are parent- report instruments for assessing communicative skills in infants and toddlers. The infant form (Level I), designed for children between 8 and 18 months, contains an 89-word vocabulary checklist with separate columns for comprehension and production. There are two equivalent forms of the toddler form (Level II, Forms A and B), both designed for children between 16 and 30 months. Each form contains 100 vocabulary items. Use appropriate norming tables for girls and boys to furnish raw score values for every 5th percentile level from the 5th to the 99th rank.

Observed level of inhibitory control via the Stop Signal Task

Inhibitory control will be assessed by the Stop Signal Task (SST) during an MRI scan. The task speed adjusts based on performance and a single response time score will be outputted for each participant. The key neural measure is the degree of blood oxygenation-level dependent (BOLD) signal during stop trials relative to go trials (i.e., the "stop > go" contrast over the entire trial period).

Observed Parental Self-Concept

The PSET involves visual presentation of single words or short phrases in the parenting domain (e.g., kind, supportive, enforces rules) seen under two different instruction conditions. The identity condition will ask participants to indicate via a button press whether the word or phrase describes them as a parent (left index finger = yes, right index finger = no). The control condition will ask participants to indicate via a button press whether the word or phrase is a quality that can change for a parent (yes/no). Scores are percent endorsement of developmentally-supportive (DS) and developmentally-unsupportive (DU) items in each condition. The key neural contrasts are neural activation during the presentation of (a) identity > control trials and (b) identity-yes > identity-no trials.

Coded rate of responsive caregiving via conversational turns

Conversational turns is a simple coding scheme designed to record timing, quantity, and length of caregiver and child utterances.

Assessment of parent's warmth and hostility towards their child through the use of the Iowa Family Interaction Rating Scales

The Iowa family interaction rating scales were used to assess parent's warmth and hostility towards their partner, their perceived warmth and hostility received from their partner, and warmth and hostility towards their child. The questionnaire is divided into 3 parts; the first 10 questions ask how you have behaved towards your partner, the next 10 ask how your partner has behaved towards you, and the final 10 questions ask how you have behaved towards your child. There are 2 scales for each part of the questionnaire, warmth (6 items) and hostility (4 items). For both scales each item has a possible 7 responses. Each scale reverse scored and then summed by adding each item score, giving a possible range of 0-42 for the warmth scale and 0-28 for the hostility scale. Higher scores indicate higher levels of warmth/hostility respectively.

Secondary Outcome Measures

Mobile Messaging for Responsive Caregiving (MMRC)

Caregiver's self-reported rate of responsive caregiving interactions between child and caregiver.

Demographic information

Demographic information including socioeconomic status, age and sex of caregiver and child, education level, race/ethnicity

Incidence of early adversity assessed via the Adverse Childhood Experiences (ACEs)

The ACE is a 10-item measure of childhood adversity and is often used as a predicter of poorer outcomes later in life. The higher the score out of 10, the more likely for poor outcomes. Sum the scores of all responses 1-10 for total ACE score. Reverse code the emotional neglect question, question 10, which counts as an ACE if either sub-question is answered "No." The developers suggest not including the supplemental questions in the Total ACE score. They recommend remaining true to the original ACE 10 categories so we can compare data across sites. If desired, you can sum the scores on the supplementary questions, and create a supplementary grand total to examine separately. TotalACES=total ACE score TotalSupp=sum of supplemental questions TotalAll=Sum of ACE score and supplemental question score

Assessment of mental health domains across psychiatric conditions via the use of the PhenX Broad Psychopathology questionnaire

This measure consists of 23 questions that assess 13 psychiatric domains, including depression, anger, mania, anxiety, somatic symptoms, suicidal ideation, psychosis, sleep problems, memory, repetitive thoughts and behaviors, dissociation, personality functioning, and substance use. Each item inquires about how much (or how often) the individual has been bothered by the specific symptom during the past 2 weeks.

Intervention Fidelity assessed through use of a fidelity criteria rubric

Intervention Fidelity is assessed by the number of required items completed from a checklist of required actions for the given intervention.

Intervention Dosage as assessed by number of sessions complete

Intervention Dosage is assessed by the number of completed sessions for each intervention. Total FIND Sessions Complete = Count of sessions complete (0-10) Total HTP Sessions Complete = Count of sessions complete (0-10)

Assessment of unpredictability and fragmentation of early-life environments in infants and children through the use of the Questionnaire of Unpredictability in Childhood (QUIC)

The QUIC, a reliable and valid self-report assessment of exposure to unpredictability in the social, emotional, and physical domains during early life, is a brief, comprehensive, and promising instrument for predicting risk for mental illness. The QUIC consists of an overall score and five separate subscale scores. Higher scores indicate more exposure to unpredictability in childhood. To obtain the overall score or subscale scores, reverse score select items (indicated by an R after the item number) and then calculate the sum of the items in each scale: Parental monitoring and involvement = 1R + 3R + 4R + 5R + 6R + 7R + 9R + 10R + 14R Parental predictability = 2 + 8R + 11 + 12 + 15R + 16 + 17R + 31 + 32 + 33 + 34 + 35 Parental environment = 18 + 19 + 21 + 22 + 28R + 29 + 30 Physical environment = 13 + 20 + 26 + 27 + 36R + 37 + 38 Safety and security = 23 + 24 + 25 Overall = Sum of all subscales.

Self-reported substance use and treatment history as assessed by questionnaire modified from PhenX and iOpen

Questionnaire developed from PhenX and iOpen to assess substance use and treatment history.

Full Information

NCT ID

NCT04749771

First Posted

February 1, 2021

Last Updated

March 27, 2023

Sponsor

University of Oregon

1. Study Identification

Unique Protocol Identification Number

NCT04749771

Brief Title

A Scaleable Video Coaching Intervention for Opioid-using Mothers

Official Title

A Scaleable Video Coaching Intervention for Opioid-using Mothers

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 4, 2021 (Actual)

Primary Completion Date

May 31, 2025 (Anticipated)

Study Completion Date

May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Oregon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Child Behavior, Parent-Child Relations, Substance Use, Substance Abuse

Keywords

parent training, early adversity, early intervention, manualized intervention, high-risk children, parenting, fMRI

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Masking

Participant

Masking Description

Research assistants collecting the data during lab visits will not know the condition of the participant and will therefore not be biased during data collection.

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Filming Interactions to Nurture Development (FIND)

Arm Type

Experimental

Arm Description

Arm Title

The Healthy Toddler Program (HTP)

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Filming Interactions to Nurture Development

Other Intervention Name(s)

FIND

Intervention Description

Intervention Type

Behavioral

Intervention Name(s)

The Healthy Toddler Program

Other Intervention Name(s)

HTP

Intervention Description

Primary Outcome Measure Information:

Title

Incidence of parenting stress via the Parent Stress Index-IV

Description

Time Frame

Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint

Title

Caregiver's perceived sense of competency in parenting via the Parent Sense of Competency scale (PSOC)

Description

Time Frame

Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint

Title

Assessment of the caregivers motivation via measurement on the Behavioral Inhibition System and Behavioral Activation System (BIS/BAS) scale

Description

Time Frame

Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint

Title

Assessment of emotional or behavioral problems in children as assessed by the SDQ-Infant questionnaire

Description

Time Frame

Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint

Title

Measurement of Opioid Craving via Opioid Craving Scale

Description

Time Frame

Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint

Title

Self-report of income, occupation and financial strain via the ECHO measure (Income, Occupation, Financial Strain)

Description

This measure is a 9-item self-report of income, occupation and financial strain.

Time Frame

Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint

Title

Measurement of social support via the Social Support Questionnaire

Description

Time Frame

Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint

Title

Self-report of commitment and support in regards to family members as assessed by the Cohesion subscale of the Family Enviornment Scale

Description

Time Frame

Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint

Title

Communicative skills assessed via the MacArthur Communicative Development Inventories (MCDI)

Description

Time Frame

Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint

Title

Observed level of inhibitory control via the Stop Signal Task

Description

Time Frame

Change from baseline at endpoint (3-4 months post-baseline)

Title

Observed Parental Self-Concept

Description

Time Frame

Change from baseline at endpoint (3-4 months post-baseline)

Title

Coded rate of responsive caregiving via conversational turns

Description

Conversational turns is a simple coding scheme designed to record timing, quantity, and length of caregiver and child utterances.

Time Frame

Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint

Title

Assessment of parent's warmth and hostility towards their child through the use of the Iowa Family Interaction Rating Scales

Description

Time Frame

Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint

Secondary Outcome Measure Information:

Title

Mobile Messaging for Responsive Caregiving (MMRC)

Description

Caregiver's self-reported rate of responsive caregiving interactions between child and caregiver.

Time Frame

Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint

Title

Demographic information

Description

Demographic information including socioeconomic status, age and sex of caregiver and child, education level, race/ethnicity

Time Frame

Baseline

Title

Incidence of early adversity assessed via the Adverse Childhood Experiences (ACEs)

Description

Time Frame

Baseline

Title

Assessment of mental health domains across psychiatric conditions via the use of the PhenX Broad Psychopathology questionnaire

Description

Time Frame

Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint

Title

Intervention Fidelity assessed through use of a fidelity criteria rubric

Description

Intervention Fidelity is assessed by the number of required items completed from a checklist of required actions for the given intervention.

Time Frame

Assessed at the conclusion of the intervention, directly before endpoint (3-4 months post-baseline)

Title

Intervention Dosage as assessed by number of sessions complete

Description

Time Frame

Assessed at the conclusion of the intervention, directly before endpoint (3-4 months post-baseline)

Title

Assessment of unpredictability and fragmentation of early-life environments in infants and children through the use of the Questionnaire of Unpredictability in Childhood (QUIC)

Description

Time Frame

At Baseline

Title

Self-reported substance use and treatment history as assessed by questionnaire modified from PhenX and iOpen

Description

Questionnaire developed from PhenX and iOpen to assess substance use and treatment history.

Time Frame

Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint

10. Eligibility

Sex

All

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alexander S Wagnon, B.S.

Phone

541-346-8064

awagnon@uoregon.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Elizabeth Backus, B.A.

Phone

541-346-3442

ebackus@uoregon.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philip A Fisher, Ph.D.

Organizational Affiliation

University of Oregon

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Oregon

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97403

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexander S Wagnon, B.S.

Phone

541-346-8064

awagnon@uoregon.edu

First Name & Middle Initial & Last Name & Degree

Philip A Fisher, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All de-identified data collected from the study will be eligible for sharing externally. Audio/Video cannot be shared due to confidentiality, however data coded from these types of files will be made available.

IPD Sharing Time Frame

Eligible IPD will be made available 1-year after the study is complete.

IPD Sharing Access Criteria

IPD access requests must be approved by the study's Principal Investigator, Dr. Philip Fisher. Requests should include information about who will be given access to the IPD and what the IPD will be used for. If approved, a Data Use Agreement (DUA) will need to be completed between the University of Oregon and the institution where the IPD will be sent.

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A Scaleable Video Coaching Intervention for Opioid-using Mothers

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