AzTrials
AzTrials

Child BehaviorNCT04749771

A Scaleable Video Coaching Intervention for Opioid-using Mothers

A study testing Filming Interactions to Nurture Development and The Healthy Toddler Program in people with Child Behavior and Parent-Child Relations, run by University of Oregon at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages Up to 50 years
What is being tested?
Filming Interactions to Nurture Development and The Healthy Toddler Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteUnited States
Study dates
4 Jun 2021to 31 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 50 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Alexander S Wagnon, B.S. contact

541-346-8064

awagnon@uoregon.edu

Elizabeth Backus, B.A. contact

541-346-3442

ebackus@uoregon.edu

United States1 site, 1 recruiting

  • University of Oregon

    Eugene, Oregon, 97403

    Alexander S Wagnon, B.S., 541-346-8064, awagnon@uoregon.edu

    Philip A Fisher, Ph.D.

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
Filming Interactions to Nurture Development, The Healthy Toddler Program
Keywords
parent training, early adversity, early intervention, manualized intervention, high-risk children, parenting, fMRI
Medical subject headings
Child Behavior, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Filming Interactions to Nurture DevelopmentBehavioural

    Also called FIND

    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.

  • The Healthy Toddler ProgramBehavioural

    Also called HTP

    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.

Study groups in NCT04749771
Study groupRoleWhat they receive
Filming Interactions to Nurture Development (FIND)ExperimentalFIND 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.
Receives: Behavioral: Filming Interactions to Nurture Development
The Healthy Toddler Program (HTP)Active comparatorHTP, 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.
Receives: Behavioral: The Healthy Toddler Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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

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

  3. 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.

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

  4. 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.

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

  5. 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

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. 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).

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

  11. 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.

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

  12. 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.

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

  13. 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.

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

Secondary outcomes (8)

  1. Mobile Messaging for Responsive Caregiving (MMRC)

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

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

  2. Demographic information

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

    Measured: Baseline

  3. 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

    Measured: Baseline

  4. 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.

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

  5. 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.

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

  6. 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)

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

  7. 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.

    Measured: At Baseline

  8. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2021
  2. Study start4 Jun 2021
  3. Primary completion31 May 2025 (estimated)
  4. Study completion31 May 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Participant
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04749771
Sponsor's protocol ID
256792
Status last verified
Mar 2023
First submitted
1 Feb 2021
Last updated
29 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • National Institutes of Health. Improve Treatments for Opioid Misuse and Addiction: NIH Heal Intitiative. 2018; https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/improve-treatments-opioid-misuse-addiction. Accessed September 17, 2018.

  • Patrick SW, Davis MM, Lehmann CU, Cooper WO. Increasing incidence and geographic distribution of neonatal abstinence syndrome: United States 2009 to 2012. J Perinatol. 2015 Aug;35(8):650-5. doi: 10.1038/jp.2015.36. Epub 2015 Apr 30.

    PubMed 25927272

  • National Institutes of Health. HEAL Initiative Research Plan. 2018; https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/heal-initiative-research-plan. Accessed September 17, 2018.

  • National Institute on Drug Abuse. Dramatic Increases in Maternal Opioid Use and Neonatal Abstinence Syndrome. 2015; https://www.drugabuse.gov/related-topics/trends-statistics/infographics/dramatic-increases-in-maternal-opioid-use-neonatal-abstinence-syndrome. Accessed September 17, 2018.

  • Patrick SW, Schumacher RE, Benneyworth BD, Krans EE, McAllister JM, Davis MM. Neonatal abstinence syndrome and associated health care expenditures: United States, 2000-2009. JAMA. 2012 May 9;307(18):1934-40. doi: 10.1001/jama.2012.3951. Epub 2012 Apr 30.

    PubMed 22546608

  • Rutherford HJV, Barry DT, Mayes LC. Family-Focused Approaches to Opioid Addiction Improve the Effectiveness of Treatment. 2018; https://www.srcd.org/policy-media/child-evidence-briefs/opioid-addiction. Accessed September 18, 2018.

  • Luby JL. Poverty's Most Insidious Damage: The Developing Brain. JAMA Pediatr. 2015 Sep;169(9):810-1. doi: 10.1001/jamapediatrics.2015.1682. No abstract available.

    PubMed 26191940

  • Maheu FS, Dozier M, Guyer AE, Mandell D, Peloso E, Poeth K, Jenness J, Lau JY, Ackerman JP, Pine DS, Ernst M. A preliminary study of medial temporal lobe function in youths with a history of caregiver deprivation and emotional neglect. Cogn Affect Behav Neurosci. 2010 Mar;10(1):34-49. doi: 10.3758/CABN.10.1.34.

    PubMed 20233954

  • Shaw DS, Vondra JI. Infant attachment security and maternal predictors of early behavior problems: a longitudinal study of low-income families. J Abnorm Child Psychol. 1995 Jun;23(3):335-57. doi: 10.1007/BF01447561.

    PubMed 7642841

  • Quevedo K, Waters TE, Scott H, Roisman GI, Shaw DS, Forbes EE. Brain activity and infant attachment history in young men during loss and reward processing. Dev Psychopathol. 2017 May;29(2):465-476. doi: 10.1017/S0954579417000116.

    PubMed 28401835

  • Blair C, Raver CC. Poverty, Stress, and Brain Development: New Directions for Prevention and Intervention. Acad Pediatr. 2016 Apr;16(3 Suppl):S30-6. doi: 10.1016/j.acap.2016.01.010.

    PubMed 27044699

  • Wachs TD, Georgieff M, Cusick S, McEwen BS. Issues in the timing of integrated early interventions: contributions from nutrition, neuroscience, and psychological research. Ann N Y Acad Sci. 2014 Jan;1308:89-106. doi: 10.1111/nyas.12314. Epub 2013 Dec 19.

    PubMed 24354763

  • Lowell DI, Carter AS, Godoy L, Paulicin B, Briggs-Gowan MJ. A randomized controlled trial of Child FIRST: a comprehensive home-based intervention translating research into early childhood practice. Child Dev. 2011 Jan-Feb;82(1):193-208. doi: 10.1111/j.1467-8624.2010.01550.x.

    PubMed 21291437

  • Gardner F, Shaw DS, Dishion TJ, Burton J, Supplee L. Randomized prevention trial for early conduct problems: effects on proactive parenting and links to toddler disruptive behavior. J Fam Psychol. 2007 Sep;21(3):398-406. doi: 10.1037/0893-3200.21.3.398.

    PubMed 17874925

  • Shaw DS, Dishion TJ, Supplee L, Gardner F, Arnds K. Randomized trial of a family-centered approach to the prevention of early conduct problems: 2-year effects of the family check-up in early childhood. J Consult Clin Psychol. 2006 Feb;74(1):1-9. doi: 10.1037/0022-006X.74.1.1.

    PubMed 16551138

Questions about this trial

What is this clinical trial studying?

A study testing Filming Interactions to Nurture Development and The Healthy Toddler Program in people with Child Behavior and Parent-Child Relations, run by University of Oregon at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alexander S Wagnon, B.S. (541-346-8064, awagnon@uoregon.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of parenting stress via the Parent Stress Index-IV (time frame: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04749771, which also lists 108 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in