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The Supporting Early Learning Study (SEAL)

7 septembre 2022 mis à jour par: University of Oregon

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Anticipé)

256

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • États-Unis
    • Oregon
      • Eugene, Oregon, États-Unis, 97403
        • Recrutement
        • University of Oregon
        • Chercheur principal:
          • Philip A Fisher, Ph.D.
        • Contact:
          • Shannon J Peake, PhD
          • Numéro de téléphone: 541-600-4424
          • E-mail: peake@uoregon.edu

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

1 an et plus (Enfant, Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion:

  • 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

Exclusion:

  • 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)
  • 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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Filmer les interactions pour favoriser le développement (FIND)
FIND est une brève intervention de coaching vidéo qui implique une rétroaction fournie par le coach au soignant à l'aide de courts extraits de films dérivés d'une vidéo d'interaction soignant-enfant. Le coaching vise à montrer aux soignants des cas dans lesquels ils s'engagent dans des interactions favorables au développement pendant les séances de coaching. FIND est livré sur 10 sessions hebdomadaires d'une durée de 30 à 45 minutes. Le processus commence par une première séance au cours de laquelle l'entraîneur donne un aperçu, enregistre 10 à 15 minutes d'interaction soignant-enfant, puis introduit le concept de service et de retour. La vidéo est montée pour montrer de brefs clips dans lesquels le soignant est engagé dans la première des cinq composantes spécifiques du service et du retour basées sur le soignant. La semaine suivante, le coach FIND passe en revue en détail les clips montés avec le soignant. Les sessions se poursuivent, alternant entre les séances de tournage et de coaching jusqu'à ce que les cinq composantes aient été couvertes séquentiellement.
Comportemental: Filming Interactions to Nurture Development
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.
Autres noms:
  • TROUVER
Comparateur actif: Le programme Healthy Toddler (HTP)
HTP, l'intervention de contrôle actif, consiste en des séances hebdomadaires alternant entre (a) des séances de coaching couvrant l'un des cinq domaines du développement de l'enfant (moteur, cognitif, langage, jeu et socio-émotionnel et (b) des séances d'observation qui comprendront un examen de la séance de coaching précédente et une observation et une discussion de l'interaction soignant-enfant. Cette intervention consistera en 10 séances d'une durée de 25 à 30 minutes chacune. Le coach ne participera à aucun tournage ou coaching vidéo, mais pourra discuter des problèmes de soins. Le matériel PTH est adapté du programme Partners for a Healthy Baby développé par le Center for Prevention and Early Intervention Policy de la Florida State University.
Comportemental: The Healthy Toddler Program
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.
Autres noms:
  • HTP

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Niveau observé de contrôle inhibiteur via la tâche de signal d'arrêt
Délai: Changement de la ligne de base au point final (3-4 mois après la ligne de base)
Le contrôle inhibiteur sera évalué par la tâche de signal d'arrêt (SST) lors d'une IRM. La vitesse de la tâche s'ajuste en fonction des performances et un score de temps de réponse unique sera généré pour chaque participant. La mesure neuronale clé est le degré de signal dépendant du niveau d'oxygénation du sang (BOLD) pendant les essais d'arrêt par rapport aux essais de départ (c'est-à-dire le contraste "arrêt> départ" sur toute la période d'essai).
Changement de la ligne de base au point final (3-4 mois après la ligne de base)
Taux codé de soins réactifs via des tours de conversation
Délai: Changement par rapport à la ligne de base au point final (3-4 mois après la ligne de base) et 6 mois après le point final
Les tours de conversation sont un schéma de codage simple conçu pour enregistrer le moment, la quantité et la longueur des énoncés du soignant et de l'enfant.
Changement par rapport à la ligne de base au point final (3-4 mois après la ligne de base) et 6 mois après le point final
Incidence of parenting stress via the parent stress index IV
Délai: 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
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
Délai: 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.
Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Self-reported level of perceived sense of competency
Délai: 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
Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Parent Reward Task (PRT) behavior and associated brain activity
Délai: 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.
Change from baseline at endpoint (3-4 months post-baseline)
Concentration of hair cortisol
Délai: 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)
Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Self-reported incidence of challenging child behaviors
Délai: 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).
Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Self-reported level of social-emotional development
Délai: 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.
Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Observed spoken language via LENA audio recordings
Délai: 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.
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
Délai: 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.
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
Délai: 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
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
Délai: 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
Change from baseline at endpoint (3-4 months post-baseline)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Demographics
Délai: Baseline
Demographic information including socioeconomic status, age and sex of caregiver and child, education level, race/ethnicity
Baseline
Incidence of early adversity
Délai: Baseline
Incidence of early adversity measured via the Adverse Childhood Experiences (ACEs)
Baseline
Incidence of poor caregiver mental health
Délai: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
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]).
Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Number of intervention sessions completed
Délai: reported at end of intervention, 3-4 months post-baseline
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.
reported at end of intervention, 3-4 months post-baseline
Percentage of intervention sessions at fidelity
Délai: reported at end of intervention, 3-4 months post-baseline
Percentage of the 10 total sessions that are at fidelity using a fidelity rubric.
reported at end of intervention, 3-4 months post-baseline

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Oregon

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

29 octobre 2019

Achèvement primaire (Anticipé)

31 octobre 2023

Achèvement de l'étude (Anticipé)

31 octobre 2023

Dates d'inscription aux études

Première soumission

14 août 2019

Première soumission répondant aux critères de contrôle qualité

24 septembre 2019

Première publication (Réel)

27 septembre 2019

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 septembre 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 septembre 2022

Dernière vérification

1 août 2022

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 230949

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Oui

Description du régime IPD

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.

Délai de partage IPD

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

Critères d'accès au partage IPD

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

Type d'informations de prise en charge du partage d'IPD

  • Protocole d'étude
  • Plan d'analyse statistique (PAS)
  • Formulaire de consentement éclairé (ICF)
  • Rapport d'étude clinique (CSR)
  • Code analytique

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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