NCT04749771

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

June 4, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

4 years

First QC Date

February 1, 2021

Last Update Submit

March 27, 2023

Conditions

Child BehaviorParent-Child RelationsSubstance UseSubstance Abuse

Keywords

parent trainingearly adversityearly interventionmanualized interventionhigh-risk childrenparentingfMRI

Outcome Measures

Primary Outcomes (13)

  • 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

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

  • 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

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

  • 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.

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

  • 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.

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

  • 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

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

  • 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.

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

  • 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.

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

  • 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.

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

  • 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.

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

  • 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).

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

  • 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.

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

  • 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.

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

  • 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.

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

Secondary Outcomes (8)

  • Mobile Messaging for Responsive Caregiving (MMRC)

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

  • Demographic information

    Baseline

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

    Baseline

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

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

  • Intervention Fidelity assessed through use of a fidelity criteria rubric

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

  • +3 more secondary outcomes

Study Arms (2)

Filming Interactions to Nurture Development (FIND)

EXPERIMENTAL

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.

Behavioral: Filming Interactions to Nurture Development

The Healthy Toddler Program (HTP)

ACTIVE COMPARATOR

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.

Behavioral: The Healthy Toddler Program

Interventions

Filming Interactions to Nurture DevelopmentBEHAVIORAL

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 collected in the home.

Also known as: FIND
Filming Interactions to Nurture Development (FIND)
The Healthy Toddler ProgramBEHAVIORAL

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.

Also known as: HTP
The Healthy Toddler Program (HTP)

Eligibility Criteria

AgeUp to 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oregon

Eugene, Oregon, 97403, United States

RECRUITING

Related Publications (108)

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MeSH Terms

Conditions

Child BehaviorSubstance-Related Disorders

Condition Hierarchy (Ancestors)

BehaviorChemically-Induced DisordersMental Disorders

Study Officials

  • Philip A Fisher, Ph.D.

    University of Oregon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander S Wagnon, B.S.

CONTACT

541-346-8064awagnon@uoregon.edu

Elizabeth Backus, B.A.

CONTACT

541-346-3442ebackus@uoregon.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2021

First Posted

February 11, 2021

Study Start

June 4, 2021

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

March 29, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Eligible IPD will be made available 1-year after the study is complete.
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.

Locations

US(1)