Child BehaviorSEALNCT04107506
The Supporting Early Learning Study
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.
Trial summary
FIND (Filming Interactions to Nurture Development) is a potentially disruptive innovation in the field of early childhood intervention. The scientific premise of this proposed work, for which the investigators have strong preliminary evidence, is that for families experiencing economic adversity and related stressors… Read more about this study
- Who is it for?
- Ages 12 months and olderHealthy volunteers can take part
- Conditions the study is for
- Child Behavior, Parent-Child Relations
- What is being tested?
- Filming Interactions to Nurture Development and The Healthy Toddler Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2019to 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 12 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Must be a primary caregiver (18 years or older) with a child between the ages of 12-36 months at study entry
- Must live at or below 130% of the federal poverty line or receive services through foster care, TANF, SSI, or be currently homeless
Who cannot join
- Caregiver does not have custody of their child at least half-time each week
- Caregiver has metal implants, metal fragments, pacemaker, or other electronic medical implant
- Caregiver is claustrophobic
- Caregiver weighs > 550 lbs.
- Caregiver is or thinks they may be pregnant
- Caregiver has history of neurological disorders (e.g. twitching of the face, arms or legs; seizures)
Show all 12Show fewer
- Caregiver has tattoos above the neck
- Caregiver has history of central nervous system infection (e.g. meningitis) or brain tumor
- Caregiver has muscular or myotonic dystrophy (i.e. a condition characterized by tonic muscle spasms)
- Caregiver has a significant visual impairment that cannot be corrected by glasses or contacts (e.g. strabismus)
- Caregiver has history of concussion or other brain trauma
- Caregiver is currently taking psychoactive medications (e.g. SSRIs)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RCT of FIND Video Coaching Intervention for Caregivers Facing Economic Adversity
FIND (Filming Interactions to Nurture Development) is a potentially disruptive innovation in the field of early childhood intervention. The scientific premise of this proposed work, for which the investigators have strong preliminary evidence, is that for families experiencing economic adversity and related stressors with children ages 12-36 months, the FIND video-coaching program is a potent and efficient tool that addresses many of the known limitations of existing parenting programs and therefore has great potential for achieving impact at scale to support low-income children's optimal development. Our research on FIND to date (including a recently completed randomized efficacy trial) provides evidence of effects on responsive caregiving and key child developmental outcomes at lower dosages (and with greater potential for scalability) than do most existing programs. Preliminary data also suggest that FIND may be especially effective for caregivers with high levels of adverse early life experiences (who are typically difficult to engage/impact). Finally, and potentially quite noteworthy, preliminary data indicate that FIND may achieve such effects via improvement in specific domains of underlying caregiver brain functioning. This research therefore aims to conduct a randomized effectiveness trial in the context of a diverse sample of low-income families with children ages 12-36 months (at study entry) using a longitudinal design with an active control condition.
Read the detailed description
The investigators will test the central hypothesis that associations between (a) increases in responsive caregiving (the main FIND target) and (b) subsequent caregiver well-being and child developmental and biobehavioral outcomes (secondary targets), will be partially mediated through (c) changes in caregiver neuroimaging-based and behavioral measures of inhibitory control and parent self-concept. The investigators will also examine moderators of hypothesized intervention effects.
Aim 1: Quantify main effects of FIND on intervention targets (changes in responsive caregiving) and related caregiver and child outcomes.
Hypothesis 1a: Compared with an active control, FIND will significantly increase developmentally supportive, responsive caregiving immediately post-intervention and will endure at the 6-month longitudinal follow-up. These effects will be associated with enduring improvements in self-reported caregiving self-efficacy and stress.
Hypothesis 1b: Compared with an active control, FIND will significantly improve child developmental outcomes on cognitive, socioemotional, expressive language and biobehavioral measures (including child chronic stress assessed via hair cortisol concentrations, HCC and Heart Rate Variability, HRV), as well as measures of caregiver and child well-being. The investigators will also test whether FIND-related increases in responsive caregiving (Hypothesis 1a) are associated (at postintervention and 6-month follow-up) with child outcomes.
Aim 2: Use fMRI to identify process-level neural mechanisms underlying FIND intervention effects (i.e., why FIND works) and variations in these effects (i.e., for whom FIND works). The investigators hypothesize that FIND-related changes in underlying brain and behavioral mechanisms of caregiver inhibitory control and parenting self-concept will partially mediate observed changes in responsive caregiving. The investigators will also determine how between-subjects variation in changes in these brain measures is associated with differential response to sustained intervention impacts on responsive caregiving, which could be key in future work on increasing the impact of FIND for a broader range of recipients and on developing adaptations for low-responding groups.
Aim 3: Determine moderators of intervention impact, including child and caregiver variables and intervention fidelity and dosage. The investigators hypothesize that the relationship between FIND-related changes in caregiver brain activity, caregiving behavior, and caregiver/child outcomes will be moderated by characteristics of the family, including caregiver past/current adversity, family socioeconomic status, and child behavior.
The investigators further hypothesize that intervention effects will be moderated by fidelity and dosage. Work on this aim will subsequently enable the investigators to develop supplemental strategies to support those for whom FIND is less effective.
Assignment to group: Participants will be randomized to one of two conditions (FIND intervention or active control) before their baseline research visit. While multiple caregivers from one family may participate in the FIND intervention or active control condition (which will be documented and included in analyses), the primary caregiver from each eligible family will be the target participant. This participant will be the one randomized to condition, asked to complete the assessments, and, if they are in the FIND condition, the focus of the videos used in the intervention. Similarly, if families have more than one eligible child in the target age range, the investigators will ask caregivers to select one child who will be the focus of the videos and research assessments.
Intervention delivery. For the proposed study, the investigators will train coaches to fidelity to deliver either the FIND intervention or the active control intervention. The investigators have extensive experience and well-established protocols for training and maintaining fidelity during intervention trials, including video-based interventions. To minimize between-group differences in coach demographics, the investigators will match coaches who are delivering each intervention as closely as possible on levels of education and early childhood experience, and will include this information as covariates in our analyses of intervention effects. Although the investigators do not anticipate contamination of the FIND material into the active control, it is noteworthy that such contamination will narrow any differences between the groups, thus providing a more rigorous test of our hypotheses.
FIND intervention. FIND is a brief home-based video coaching intervention. FIND 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 coaching focuses specifically and exclusively on showing caregivers instances in which they are engaging in developmentally supportive interactions during coaching sessions. FIND is delivered in 10 weekly home visits, each of which lasts 30-45 minutes. The process begins with an initial visit in which the coach provides an overview, records 10-15 minutes of the caregiver and child engaged in everyday interactions, and 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 and precisely defined 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, with each component building on prior ones. The hierarchical nature of the program is intentionally designed so that even partial completion of the program is hypothesized to confer benefits.
FIND editing and coaching processes are fully manualized, including certification protocols, fidelity forms, and rubrics, and designed to be both straightforward and highly replicable. For editing, three short clips are selected from the video gathered in the home. Each clip begins with a brief onscreen text description that is read aloud by the coach, which cues the caregiver to notice the child's initiation (serve) and his/her own supportive response (return). Then the clip plays three times: (1) all the way through; (2) with embedded pauses, which cue the coach to pause and comment on specific elements of the interaction; and (3) all the way through again, giving the caregiver an opportunity to consolidate what he or she has learned. As the clip is playing, the coach narrates the serve and return process. To ensure all families receive the full benefit of FIND, all FIND coaches will participate in the four-phase FIND certification process for coaching and editing, which includes an initial training, fidelity training, application for certification, and certification. The investigators have used this process to train more than 80 certified FIND interventionists to date.
Active control intervention. The active control condition for this study is designed to maximize rigor by controlling for nonspecific effects of FIND (supportive home visiting, child observation, and information about development) to determine the unique impact of the hypothesized "active ingredients" of FIND (i.e., specialized microsocial video coaching on the five caregiver-based components of serve and return). As such, families randomly assigned to the control condition will receive weekly home visits 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 home visits each lasting 25-30 minutes. The coach will not engage in any filming or video coaching, but will still be able to discuss caregiving concerns. Materials are adapted from the Partners for a Healthy Baby curriculum developed by Florida State University's Center for Prevention and Early Intervention Policy.
- Conditions
- Child Behavior, Parent-Child Relations
- 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
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 home-based 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 coaching focuses on showing caregivers instances in which they are engaging in developmentally-supportive interactions during coaching sessions. FIND is delivered over 10 weekly home visits lasting 30-45 minutes. The process begins with an initial visit 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.
The Healthy Toddler ProgramBehavioural
Also called HTP
HTP, the active control intervention, consists of weekly home visits 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 home visits 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: The Healthy Toddler Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of parenting stress via the parent stress index IV
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
Incidence of parenting stress and child behaviors via the parent daily report
A caregiver self-report of the incidence of challenging child behaviors and whether the caregiver perceives the behaviors to be stressful if they are occurring.
Measured: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Self-reported level of perceived sense of competency
Caregiver's perceived sense of competency in parenting via the Parent Sense of Competency scale. Items are on a 4-point scale ranging from "strongly agree" to "strongly disagree." Higher scores indicate greater parenting self-competency.
The measure includes two subscales and a total score:
- satisfaction (9 items) with items summed into a score ranging between 9-36
- efficacy (8 items) with items summed into a score ranging between 8-32
- total score (18 items) with items summed into a score ranging between 18-72
Measured: 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).
Measured: Change from baseline at endpoint (3-4 months post-baseline)
Parent Reward Task (PRT) behavior and associated brain activity
Self-reported ratings of stimuli will be used as a behavioral measure of reward (higher = better), and ventral striatum activity will be used as a measure of reward responsivity using a contrast of own child > other child.
Measured: Change from baseline at endpoint (3-4 months post-baseline)
Concentration of hair cortisol
Cumulative HPA axis activity measured via hair cortisol concentrations (HCC)
Measured: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Self-reported incidence of challenging child behaviors
Self-report measures of challenging child behaviors, including internalizing and externalizing behaviors, via the Child Behavior Checklist (CBCL).
Measured: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Self-reported level of social-emotional development
Caregiver report of their child's social emotional problems and competencies. The measure consists of 42 items that are on a 3-point scale (0=not true/rarely, 1=somewhat true/sometimes, 2=very true/always). For certain items a respondent may also respond "N" which means "no opportunity".
The measure includes two subscales:
- problem total score (31 items) with items summed into a score ranging between 31-93; total score is compared to cut scores (age in months, gender, and cut score) to indicate if there is a possible problem. The problem total cut score is set at the 25th percentile.
- competence total score (11 items) with items summed into a score ranging between 11-33; total score is compared to cut scores (age in months, gender, cut score) to indicate if there is a possible problem. The competency total cut score is set at the 15th percentile.
Measured: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Observed spoken language via LENA audio recordings
LENA is an audio recording device used to record spoken language in the natural environment. Software automatically analyzes recordings into several different metrics including estimates and percentile scores for adult words spoken to child, conversational turns, child vocalizations, and audio environment.
Measured: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
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
Coded rate of responsive caregiving via the simple interactions scale
The simple interactions scale is a micro-social rating scale that assesses the quality and quantity of interaction between caregivers and their children. The scale is split into two parts: connection and reciprocity. Connection is a measure of synchrony between the caregiver-child dyad. Reciprocity is a moment-to-moment measure of serve and return interactions.
Coding for both connection and reciprocity is on a 1-3 scale (CX [1], CY [2], and CZ [3] for connections; RX [1], RY [2], and RZ [3] for reciprocity) using a flowchart and accompanying glossary of terms. Connections is rated frame by frame, while reciprocity is rated in 15-second chunks. Within Connections and Reciprocity, the X (1), Y (2), and Z (3) codes are summed and expressed as a percentage of the total video. If 20 of the 40 reciprocity time segments were coded CX, then CX = 50%. A higher percentage of Z (3) represents higher levels of connection and reciprocity in the caregiver-child interaction.
Measured: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Coded rate of responsive caregiving via the serve and return scale
The Serve and Return Scale (SRS) is a global coding system used to assess responsive parenting via the FIND 5 Elements. This scale will be used to assess the quality of caregiver responsiveness and the quantity of serve and return interaction in a 10-minute video of free-play between caregivers and their children.
Items are on a 3-point scale between low, medium, and high. Higher scores indicate greater rates of responsive caregiving.
The measure includes three subscales and a total score:
- noticing the child's serves (1 item) score ranging between 1-3
- returning the child's serves (5 items) sum score ranging between 5-15
- caregiver initiation (1 item) score ranging between 1-3
- total score (7 items) sum score ranging between 7-21
Measured: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Parent Self-Evaluation Task (PSET) behavior and associated brain activity
Percentage of developmentally-supportive (DS) and developmentally-unsupportive (DU) traits endorsed under the self instruction will be used as a behavioral measure of parenting self-concept, and medial prefrontral cortex activity (mPFC) will be measured via the Self > Change contract for DS traits
Measured: Change from baseline at endpoint (3-4 months post-baseline)
Secondary outcomes (5)
Demographics
Demographic information including socioeconomic status, age and sex of caregiver and child, education level, race/ethnicity
Measured: Baseline
Incidence of early adversity
Incidence of early adversity measured via the Adverse Childhood Experiences (ACEs)
Measured: Baseline
Incidence of poor caregiver mental health
Incidence of caregiver mental health via self-report measures of anxiety (Penn State Worry Questionnaire [PSWQ]) and depression (Center for Epidemiological Studies - Depression [CES-D]).
Measured: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Number of intervention sessions completed
The number of intervention sessions completed (i.e. dosage) will be assessed by the number of sessions completed by each participant. Total score will range from 0-10.
Measured: reported at end of intervention, 3-4 months post-baseline
Percentage of intervention sessions at fidelity
Percentage of the 10 total sessions that are at fidelity using a fidelity rubric.
Measured: reported at end of intervention, 3-4 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start29 Oct 2019
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (131)Papers the sponsor has linked to this study.
- Other trials for Child BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip A Fisher, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107506
- Sponsor's protocol ID
- 230949
- Acronym
- SEAL
- Status last verified
- Nov 2024
- First submitted
- 14 Aug 2019
- Last updated
- 10 Dec 2025
- 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, but data coded from these types of files will be made available.
Publications
Fisher PA, Frenkel TI, Noll LK, Berry M, Yockelson M. Promoting Healthy Child Development via a Two-Generation Translational Neuroscience Framework: The Filming Interactions to Nurture Development Video Coaching Program. Child Dev Perspect. 2016 Dec;10(4):251-256. doi: 10.1111/cdep.12195. Epub 2016 Aug 10.
PubMed 28936231Lynch J, Smith GD, Harper S, Hillemeier M, Ross N, Kaplan GA, Wolfson M. Is income inequality a determinant of population health? Part 1. A systematic review. Milbank Q. 2004;82(1):5-99. doi: 10.1111/j.0887-378x.2004.00302.x.
PubMed 15016244Chetty R, Stepner M, Abraham S, Lin S, Scuderi B, Turner N, Bergeron A, Cutler D. The Association Between Income and Life Expectancy in the United States, 2001-2014. JAMA. 2016 Apr 26;315(16):1750-66. doi: 10.1001/jama.2016.4226.
PubMed 27063997Stevens GD. Gradients in the health status and developmental risks of young children: the combined influences of multiple social risk factors. Matern Child Health J. 2006 Mar;10(2):187-99. doi: 10.1007/s10995-005-0062-y. Epub 2006 Mar 29.
PubMed 16570213National Center for Children in Poverty. Large numbers of children underserved by federal and state early care and education programs. 2016; http://www.nccp.org/media/releases/release_154.html. Accessed May 5, 2017.
Schmit S, Matthews H, Smith S, Robbins T. Investing in young children: A fact sheet on early care and education participation, access, and quality. Center for Law and Social Policy, Inc.(CLASP). 2013.
Reardon SF. The widening income achievement gap. Educational Leadership. 2013;70(8):10-16.
Sirin SR. Socioeconomic status and academic achievement: A meta-analytic review of research. Review of Educational Research. 2005;75(3):417-453.
Duncan GJ, Brooks-Gunn J. Consequences of growing up poor. Russell Sage Foundation; 1999.
Vernon-Feagans L, Cox M; FLF Key Investigators. The Family Life Project: an epidemiological and developmental study of young children living in poor rural communities. Monogr Soc Res Child Dev. 2013 Oct;78(5):1-150, vii. doi: 10.1111/mono.12046.
PubMed 24147448Luecken LJ, Lemery KS. Early caregiving and physiological stress responses. Clin Psychol Rev. 2004 May;24(2):171-91. doi: 10.1016/j.cpr.2004.01.003.
PubMed 15081515Brophy-Herb HE, Martoccio TL, Hillaker B, et al. Profiles of low-income maternal well-being and family climate: Relations to toddler boys' and girls' behaviors. Family Relations. 2013;62(2):326-340.
Mokrova IL, O'Brien M, Calkins SD, Leerkes EM, Marcovitch S. Family Social Status and Preschoolers' Persistence: The Role of Maternal Values and Quality of Parenting. Infant Child Dev. 2012 Nov-Dec;21(6):617-633. doi: 10.1002/icd.1761.
PubMed 25767415Cuevas K, Deater-Deckard K, Kim-Spoon J, Watson AJ, Morasch KC, Bell MA. What's mom got to do with it? Contributions of maternal executive function and caregiving to the development of executive function across early childhood. Dev Sci. 2014 Mar;17(2):224-38. doi: 10.1111/desc.12073. Epub 2014 Jan 11.
PubMed 24410963Mackey AP, Finn AS, Leonard JA, Jacoby-Senghor DS, West MR, Gabrieli CF, Gabrieli JD. Neuroanatomical correlates of the income-achievement gap. Psychol Sci. 2015 Jun;26(6):925-33. doi: 10.1177/0956797615572233. Epub 2015 Apr 20.
PubMed 25896418
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of FIND Video Coaching Intervention for Caregivers Facing Economic Adversity
- ClinicalTrials.gov ID
- NCT04107506
- Acronym / sponsor ID
- SEAL / 230949
- Conditions
- Child Behavior, Parent-Child Relations
- Keywords
- parent training, early adversity, early intervention, manualized intervention, high-risk children, parenting, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Study start
- 29 Oct 2019 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
FIND (Filming Interactions to Nurture Development) is a potentially disruptive innovation in the field of early childhood intervention. The scientific premise of this proposed work, for which the investigators have strong preliminary evidence, is that for families experiencing economic adversity and related stressors with children ages 12-36 months, the FIND video-coaching program is a potent and efficient tool that addresses many of the known limitations of existing parenting programs and therefore has great potential for achieving impact at scale to support low-income children's optimal development. Our research on FIND to date (including a recently completed randomized efficacy trial) provides evidence of effects on responsive caregiving and key child developmental outcomes at lower dosages (and with greater potential for scalability) than do most existing programs. Preliminary data also suggest that FIND may be especially effective for caregivers with high levels of adverse early life experiences (who are typically difficult to engage/impact). Finally, and potentially quite noteworthy, preliminary data indicate that FIND may achieve such effects via improvement in specific domains of underlying caregiver brain functioning. This research therefore aims to conduct a randomized effectiveness trial in the context of a diverse sample of low-income families with children ages 12-36 months (at study entry) using a longitudinal design with an active control condition.
Detailed description
The investigators will test the central hypothesis that associations between (a) increases in responsive caregiving (the main FIND target) and (b) subsequent caregiver well-being and child developmental and biobehavioral outcomes (secondary targets), will be partially mediated through (c) changes in caregiver neuroimaging-based and behavioral measures of inhibitory control and parent self-concept. The investigators will also examine moderators of hypothesized intervention effects.
Aim 1: Quantify main effects of FIND on intervention targets (changes in responsive caregiving) and related caregiver and child outcomes.
Hypothesis 1a: Compared with an active control, FIND will significantly increase developmentally supportive, responsive caregiving immediately post-intervention and will endure at the 6-month longitudinal follow-up. These effects will be associated with enduring improvements in self-reported caregiving self-efficacy and stress.
Hypothesis 1b: Compared with an active control, FIND will significantly improve child developmental outcomes on cognitive, socioemotional, expressive language and biobehavioral measures (including child chronic stress assessed via hair cortisol concentrations, HCC and Heart Rate Variability, HRV), as well as measures of caregiver and child well-being. The investigators will also test whether FIND-related increases in responsive caregiving (Hypothesis 1a) are associated (at postintervention and 6-month follow-up) with child outcomes.
Aim 2: Use fMRI to identify process-level neural mechanisms underlying FIND intervention effects (i.e., why FIND works) and variations in these effects (i.e., for whom FIND works). The investigators hypothesize that FIND-related changes in underlying brain and behavioral mechanisms of caregiver inhibitory control and parenting self-concept will partially mediate observed changes in responsive caregiving. The investigators will also determine how between-subjects variation in changes in these brain measures is associated with differential response to sustained intervention impacts on responsive caregiving, which could be key in future work on increasing the impact of FIND for a broader range of recipients and on developing adaptations for low-responding groups.
Aim 3: Determine moderators of intervention impact, including child and caregiver variables and intervention fidelity and dosage. The investigators hypothesize that the relationship between FIND-related changes in caregiver brain activity, caregiving behavior, and caregiver/child outcomes will be moderated by characteristics of the family, including caregiver past/current adversity, family socioeconomic status, and child behavior.
The investigators further hypothesize that intervention effects will be moderated by fidelity and dosage. Work on this aim will subsequently enable the investigators to develop supplemental strategies to support those for whom FIND is less effective.
Assignment to group: Participants will be randomized to one of two conditions (FIND intervention or active control) before their baseline research visit. While multiple caregivers from one family may participate in the FIND intervention or active control condition (which will be documented and included in analyses), the primary caregiver from each eligible family will be the target participant. This participant will be the one randomized to condition, asked to complete the assessments, and, if they are in the FIND condition, the focus of the videos used in the intervention. Similarly, if families have more than one eligible child in the target age range, the investigators will ask caregivers to select one child who will be the focus of the videos and research assessments.
Intervention delivery. For the proposed study, the investigators will train coaches to fidelity to deliver either the FIND intervention or the active control intervention. The investigators have extensive experience and well-established protocols for training and maintaining fidelity during intervention trials, including video-based interventions. To minimize between-group differences in coach demographics, the investigators will match coaches who are delivering each intervention as closely as possible on levels of education and early childhood experience, and will include this information as covariates in our analyses of intervention effects. Although the investigators do not anticipate contamination of the FIND material into the active control, it is noteworthy that such contamination will narrow any differences between the groups, thus providing a more rigorous test of our hypotheses.
FIND intervention. FIND is a brief home-based video coaching intervention. FIND 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 coaching focuses specifically and exclusively on showing caregivers instances in which they are engaging in developmentally supportive interactions during coaching sessions. FIND is delivered in 10 weekly home visits, each of which lasts 30-45 minutes. The process begins with an initial visit in which the coach provides an overview, records 10-15 minutes of the caregiver and child engaged in everyday interactions, and 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 and precisely defined 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, with each component building on prior ones. The hierarchical nature of the program is intentionally designed so that even partial completion of the program is hypothesized to confer benefits.
FIND editing and coaching processes are fully manualized, including certification protocols, fidelity forms, and rubrics, and designed to be both straightforward and highly replicable. For editing, three short clips are selected from the video gathered in the home. Each clip begins with a brief onscreen text description that is read aloud by the coach, which cues the caregiver to notice the child's initiation (serve) and his/her own supportive response (return). Then the clip plays three times: (1) all the way through; (2) with embedded pauses, which cue the coach to pause and comment on specific elements of the interaction; and (3) all the way through again, giving the caregiver an opportunity to consolidate what he or she has learned. As the clip is playing, the coach narrates the serve and return process. To ensure all families receive the full benefit of FIND, all FIND coaches will participate in the four-phase FIND certification process for coaching and editing, which includes an initial training, fidelity training, application for certification, and certification. The investigators have used this process to train more than 80 certified FIND interventionists to date.
Active control intervention. The active control condition for this study is designed to maximize rigor by controlling for nonspecific effects of FIND (supportive home visiting, child observation, and information about development) to determine the unique impact of the hypothesized "active ingredients" of FIND (i.e., specialized microsocial video coaching on the five caregiver-based components of serve and return). As such, families randomly assigned to the control condition will receive weekly home visits 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 home visits each lasting 25-30 minutes. The coach will not engage in any filming or video coaching, but will still be able to discuss caregiving concerns. Materials are adapted from the Partners for a Healthy Baby curriculum developed by Florida State University's Center for Prevention and Early Intervention Policy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Filming Interactions to Nurture Development (FIND) | Experimental | Behavioral: Filming Interactions to Nurture DevelopmentFIND 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. |
| The Healthy Toddler Program (HTP) | Active comparator | Behavioral: The Healthy Toddler ProgramHTP, 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. |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Must be a primary caregiver (18 years or older) with a child between the ages of 12-36 months at study entry
- Must live at or below 130% of the federal poverty line or receive services through foster care, TANF, SSI, or be currently homeless
Key exclusion criteria (12 listed)
- Caregiver does not have custody of their child at least half-time each week
- Caregiver has metal implants, metal fragments, pacemaker, or other electronic medical implant
- Caregiver is claustrophobic
- Caregiver weighs > 550 lbs.
- Caregiver is or thinks they may be pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Filming Interactions to Nurture DevelopmentAlso: FINDFIND is a brief home-based 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 coaching focuses on showing caregivers instances in which they are engaging in developmentally-supportive interactions during coaching sessions. FIND is delivered over 10 weekly home visits lasting 30-45 minutes. The process begins with an initial visit 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. | Behavioural | Filming Interactions to Nurture Development (FIND) |
| The Healthy Toddler ProgramAlso: HTPHTP, the active control intervention, consists of weekly home visits 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 home visits 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. | Behavioural | The Healthy Toddler Program (HTP) |
Primary outcome
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
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
Incidence of parenting stress and child behaviors via the parent daily report
Time frame: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
A caregiver self-report of the incidence of challenging child behaviors and whether the caregiver perceives the behaviors to be stressful if they are occurring.
Self-reported level of perceived sense of competency
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. Items are on a 4-point scale ranging from "strongly agree" to "strongly disagree." Higher scores indicate greater parenting self-competency. The measure includes two subscales and a total score: * satisfaction (9 items) with items summed into a score ranging between 9-36 * efficacy (8 items) with items summed into a score ranging between 8-32 * total score (18 items) with items summed into a score ranging between 18-72
Observed level of inhibitory control via the Stop Signal Task
Time frame: Change from baseline at endpoint (3-4 months post-baseline)
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).
Parent Reward Task (PRT) behavior and associated brain activity
Time frame: Change from baseline at endpoint (3-4 months post-baseline)
Self-reported ratings of stimuli will be used as a behavioral measure of reward (higher = better), and ventral striatum activity will be used as a measure of reward responsivity using a contrast of own child > other child.
Concentration of hair cortisol
Time frame: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Cumulative HPA axis activity measured via hair cortisol concentrations (HCC)
Self-reported incidence of challenging child behaviors
Time frame: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Self-report measures of challenging child behaviors, including internalizing and externalizing behaviors, via the Child Behavior Checklist (CBCL).
Self-reported level of social-emotional development
Time frame: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Caregiver report of their child's social emotional problems and competencies. The measure consists of 42 items that are on a 3-point scale (0=not true/rarely, 1=somewhat true/sometimes, 2=very true/always). For certain items a respondent may also respond "N" which means "no opportunity". The measure includes two subscales: * problem total score (31 items) with items summed into a score ranging between 31-93; total score is compared to cut scores (age in months, gender, and cut score) to indicate if there is a possible problem. The problem total cut score is set at the 25th percentile. * competence total score (11 items) with items summed into a score ranging between 11-33; total score is compared to cut scores (age in months, gender, cut score) to indicate if there is a possible problem. The competency total cut score is set at the 15th percentile.
Observed spoken language via LENA audio recordings
Time frame: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
LENA is an audio recording device used to record spoken language in the natural environment. Software automatically analyzes recordings into several different metrics including estimates and percentile scores for adult words spoken to child, conversational turns, child vocalizations, and audio environment.
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
Conversational turns is a simple coding scheme designed to record timing, quantity, and length of caregiver and child utterances.
Coded rate of responsive caregiving via the simple interactions scale
Time frame: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
The simple interactions scale is a micro-social rating scale that assesses the quality and quantity of interaction between caregivers and their children. The scale is split into two parts: connection and reciprocity. Connection is a measure of synchrony between the caregiver-child dyad. Reciprocity is a moment-to-moment measure of serve and return interactions. Coding for both connection and reciprocity is on a 1-3 scale (CX [1], CY [2], and CZ [3] for connections; RX [1], RY [2], and RZ [3] for reciprocity) using a flowchart and accompanying glossary of terms. Connections is rated frame by frame, while reciprocity is rated in 15-second chunks. Within Connections and Reciprocity, the X (1), Y (2), and Z (3) codes are summed and expressed as a percentage of the total video. If 20 of the 40 reciprocity time segments were coded CX, then CX = 50%. A higher percentage of Z (3) represents higher levels of connection and reciprocity in the caregiver-child interaction.
Coded rate of responsive caregiving via the serve and return scale
Time frame: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
The Serve and Return Scale (SRS) is a global coding system used to assess responsive parenting via the FIND 5 Elements. This scale will be used to assess the quality of caregiver responsiveness and the quantity of serve and return interaction in a 10-minute video of free-play between caregivers and their children. Items are on a 3-point scale between low, medium, and high. Higher scores indicate greater rates of responsive caregiving. The measure includes three subscales and a total score: * noticing the child's serves (1 item) score ranging between 1-3 * returning the child's serves (5 items) sum score ranging between 5-15 * caregiver initiation (1 item) score ranging between 1-3 * total score (7 items) sum score ranging between 7-21
Parent Self-Evaluation Task (PSET) behavior and associated brain activity
Time frame: Change from baseline at endpoint (3-4 months post-baseline)
Percentage of developmentally-supportive (DS) and developmentally-unsupportive (DU) traits endorsed under the self instruction will be used as a behavioral measure of parenting self-concept, and medial prefrontral cortex activity (mPFC) will be measured via the Self > Change contract for DS traits
5 secondary outcomes
Demographics
Time frame: Baseline
Incidence of early adversity
Time frame: Baseline
Incidence of poor caregiver mental health
Time frame: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Number of intervention sessions completed
Time frame: reported at end of intervention, 3-4 months post-baseline
Percentage of intervention sessions at fidelity
Time frame: reported at end of intervention, 3-4 months post-baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Background: PubMed 28936231Fisher PA, Frenkel TI, Noll LK, Berry M, Yockelson M. Promoting Healthy Child Development via a Two-Generation Translational Neuroscience Framework: The Filming Interactions to Nurture Development Video Coaching Program. Child Dev Perspect. 2016 Dec;10(4):251-256. doi: 10.1111/cdep.12195. Epub 2016 Aug 10.
- Background: PubMed 15016244Lynch J, Smith GD, Harper S, Hillemeier M, Ross N, Kaplan GA, Wolfson M. Is income inequality a determinant of population health? Part 1. A systematic review. Milbank Q. 2004;82(1):5-99. doi: 10.1111/j.0887-378x.2004.00302.x.
- Background: PubMed 27063997Chetty R, Stepner M, Abraham S, Lin S, Scuderi B, Turner N, Bergeron A, Cutler D. The Association Between Income and Life Expectancy in the United States, 2001-2014. JAMA. 2016 Apr 26;315(16):1750-66. doi: 10.1001/jama.2016.4226.
- Background: PubMed 16570213Stevens GD. Gradients in the health status and developmental risks of young children: the combined influences of multiple social risk factors. Matern Child Health J. 2006 Mar;10(2):187-99. doi: 10.1007/s10995-005-0062-y. Epub 2006 Mar 29.
- BackgroundNational Center for Children in Poverty. Large numbers of children underserved by federal and state early care and education programs. 2016; http://www.nccp.org/media/releases/release_154.html. Accessed May 5, 2017.
- BackgroundSchmit S, Matthews H, Smith S, Robbins T. Investing in young children: A fact sheet on early care and education participation, access, and quality. Center for Law and Social Policy, Inc.(CLASP). 2013.
- BackgroundReardon SF. The widening income achievement gap. Educational Leadership. 2013;70(8):10-16.
- BackgroundSirin SR. Socioeconomic status and academic achievement: A meta-analytic review of research. Review of Educational Research. 2005;75(3):417-453.
- BackgroundDuncan GJ, Brooks-Gunn J. Consequences of growing up poor. Russell Sage Foundation; 1999.
- Background: PubMed 24147448Vernon-Feagans L, Cox M; FLF Key Investigators. The Family Life Project: an epidemiological and developmental study of young children living in poor rural communities. Monogr Soc Res Child Dev. 2013 Oct;78(5):1-150, vii. doi: 10.1111/mono.12046.
- Background: PubMed 15081515Luecken LJ, Lemery KS. Early caregiving and physiological stress responses. Clin Psychol Rev. 2004 May;24(2):171-91. doi: 10.1016/j.cpr.2004.01.003.
- BackgroundBrophy-Herb HE, Martoccio TL, Hillaker B, et al. Profiles of low-income maternal well-being and family climate: Relations to toddler boys' and girls' behaviors. Family Relations. 2013;62(2):326-340.
- Individual participant dataSharing planned: Yes. All de-identified data collected from the study will be eligible for sharing externally. Audio/Video cannot be shared due to confidentiality, but data coded from these types of files will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip A Fisher, PhD principal investigator
University of Oregon
1 site in 1 country: see every site and its status.
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 2 inclusion and 12 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: finished, as of the sponsor's last update on 10 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 NCT04107506, which also lists 131 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 10 Dec 2025; AzTrials last refreshed its copy on 27 Oct 2026.