Recruiting

Observational Study

Sponsor:

University of Oregon

Code:

NCT04749771

Conditions

Child Behavior

Parent-Child Relations

Substance Use

Substance Abuse

Eligibility Criteria

Sex: All

Age: 0 - 50

Healthy Volunteers: Not accepted

Interventions

Filming Interactions to Nurture Development

The Healthy Toddler Program

Study Details

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.

Conditions

Child Behavior

Parent-Child Relations

Substance Use

Substance Abuse

Study ID

NCT04749771

Start date

Jun 4, 2021

Status verified date

Mar, 2023

Completion date

May 31, 2025

Anticipated

Primary completion date

May 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Filming Interactions to Nurture Development (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. 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.

active comparator: The Healthy Toddler Program (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. 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.

Interventions

Filming Interactions to Nurture Development

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 Program

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.

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 ]
  • Caregiver's perceived sense of competency in parenting via the Parent Sense of Competency scale (PSOC) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint ]
  • Measurement of Opioid Craving via Opioid Craving Scale [ Time Frame: 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) [ Time Frame: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint ]
  • Measurement of social support via the Social Support Questionnaire [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Change from baseline at endpoint (3-4 months post-baseline) ]
  • Observed Parental Self-Concept [ Time Frame: Change from baseline at endpoint (3-4 months post-baseline) ]
  • Coded rate of responsive caregiving via conversational turns [ Time Frame: 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 [ Time Frame: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint ]

Central Contacts and Locations

Central contacts

Alexander S Wagnon, B.S.

541-346-8064awagnon@uoregon.edu

Elizabeth Backus, B.A.

541-346-3442ebackus@uoregon.edu

Locations

University of Oregon

Recruiting

Eugene, Oregon, United States, 97403

Contacts

Alexander S Wagnon, B.S.

541-346-8064awagnon@uoregon.edu

Principal Investigator:

Philip A Fisher, Ph.D.

More Information

Sponsor

University of Oregon

Last update posted

Mar 29, 2023

Last verified

Mar, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oregon on 2023-03-29.