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Filming Interactions to Nurture Development for Parent-Child Relationship (SEAL Trial)
N/A
Recruiting
Led By Philip A Fisher, PhD
Research Sponsored by University of Oregon
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Awards & highlights
SEAL Trial Summary
This trial will test whether the FIND parenting program is more effective than an existing parenting program in supporting low-income children's development.
Eligible Conditions
- Childhood Behavior
- Parent-Child Relationship
SEAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Coded rate of responsive caregiving via conversational turns
Coded rate of responsive caregiving via the serve and return scale
Coded rate of responsive caregiving via the simple interactions scale
+10 moreSecondary outcome measures
Demographics
Incidence of early adversity
Incidence of poor caregiver mental health
+2 moreSEAL Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Filming Interactions to Nurture Development (FIND)Experimental Treatment1 Intervention
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.
Group II: The Healthy Toddler Program (HTP)Active Control1 Intervention
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.
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Who is running the clinical trial?
University of OregonLead Sponsor
80 Previous Clinical Trials
46,503 Total Patients Enrolled
Philip A Fisher, PhDPrincipal InvestigatorUniversity of Oregon
2 Previous Clinical Trials
619 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- The caregiver has a serious eye problem that cannot be fixed with glasses or contacts. For example, they may have a condition called strabismus.The person taking care of you has a history of neurological disorders like uncontrollable muscle movements or seizures.The person taking care of you is afraid of small or enclosed spaces.The person taking care of you has had a previous infection in their brain or a brain tumor.The person who takes care of you has a condition called muscular or myotonic dystrophy, which causes muscle spasms.The person taking care of you has had a previous head injury or concussion.The person taking care of you is currently taking medications that affect their mood or emotions.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Filming Interactions to Nurture Development (FIND)
- Group 2: The Healthy Toddler Program (HTP)
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is the study recruiting participants?
"Affirmative. According to the information published on clinicaltrials.gov, this study is actively enrolling participants with an initial posting date of October 29th 2019 and a recent update posted on September 7th 2022. This research requires 256 individuals from 1 medical facility for participation."
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Is there currently the opportunity for participation in this study?
"As evidenced on clinicaltrials.gov, recruitment for this trial is in progress. It was initially posted on October 29th 2019 and its most recent update came on September 7th 2022."
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What is the ultimate ambition of this experiment?
"The primary endpoint of this study, assessed over a period spanning three to four months post-baseline and six months after the conclusion of treatment, is the observed level of inhibitory control as measured by the Stop Signal Task. Secondary objectives encompass demographics such as parental socioeconomic status, educational attainment, age and sex; number of sessions completed (0–10); and incidence rate for anxiety (Penn State Worry Questionnaire [PSWQ]) depression (Center for Epidemiological Studies - Depression [CES-D])."
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