Parenting Programs for Childhood Development
(SEAL Trial)
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Oregon
Must not be taking: Psychoactive medications
Disqualifiers: Neurological disorders, Brain trauma, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial requires that you are not currently taking psychoactive medications (like SSRIs). If you are taking these, you may need to stop before participating.
What data supports the effectiveness of the treatment Filming Interactions to Nurture Development (FIND) in the Parenting Programs for Childhood Development trial?
Video feedback interventions, similar to FIND, have shown promise in improving parenting skills and child development by helping parents recognize and respond to their child's needs, as seen in studies like the Video Interaction Project and Video Intervention Therapy.
12345Is the Parenting Programs for Childhood Development treatment safe for humans?
The research does not provide specific safety data for the Parenting Programs for Childhood Development treatment, but generally, parenting programs are designed to improve family dynamics and child development without known safety concerns.
678910How is the treatment 'Filming Interactions to Nurture Development (FIND)' different from other parenting programs?
The FIND treatment is unique because it uses video feedback to help parents learn effective parenting skills by observing and reflecting on their interactions with their children, which is different from traditional parenting programs that may not use this visual and reflective approach.
1112131415Eligibility Criteria
This study is for primary caregivers over 18 with a child aged 12-36 months, living at or below poverty levels or receiving certain social services. Caregivers must have custody of their child at least half the time and cannot have significant visual impairments, neurological disorders, claustrophobia, weigh over 550 lbs., tattoos above the neck, history of brain infections/tumors/trauma, muscular dystrophy, metal implants/pacemakers/electronic medical implants or be pregnant.Inclusion Criteria
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 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.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
FIND intervention involves 10 weekly home-based video coaching sessions focusing on developmentally-supportive interactions
10 weeks
10 visits (in-person)
Active Control
HTP active control involves 10 weekly sessions covering child development domains without video coaching
10 weeks
10 visits (in-person)
Follow-up
Participants are monitored for caregiver and child outcomes, including responsive caregiving and stress levels
6 months
Participant Groups
The trial tests FIND (Filming Interactions to Nurture Development), an innovative video-coaching program aimed at improving parenting skills and children's development in low-income families. It compares FIND with The Healthy Toddler Program using a randomized design where participants are assigned by chance to either intervention.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of OregonEugene, OR
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Who Is Running the Clinical Trial?
University of OregonLead Sponsor
References
Use of videotaped interactions during pediatric well-child care: impact at 33 months on parenting and on child development. [2021]We performed a randomized, controlled trial to assess the impact of the Video Interaction Project (VIP), a program based in pediatric primary care in which videotaped interactions are used by child development specialists to promote early child development.
The Primary Care-Video Intervention Therapy for Growth-Vulnerable Infants. A Case Study. [2020]Perinatal growth vulnerability (e.g., Small for Gestational Age, SGA) poses the goal to not overlook subtle developmental susceptibilities and their impact on the parent-infant relationship. In this case study, we examined the application of a video-feedback intervention program to support parenting, the Primary Care-Video Intervention Therapy (PC-VIT), specifically developed to fit pediatric care characteristics. The case presentation details the principal steps of the intervention with the family of an SGA infant from birth up to toddlerhood. Findings for this family highlighted initial worries about the infant's growth. Along sessions, PC-VIT held maternal anxiety and sustained parents' abilities to recognize and talk about the infant's developmental skills and regulatory abilities. The PC-VIT shows the powerful opportunity to limit the impact of infant growth vulnerability on the parent-child relationship and socio-emotional development. Pediatricians can prevent vulnerable developmental milestones from clinical outcomes by implementing timely and effective strategies embracing mental health and parenting-related issues.
Assessing the Key to Effective Coaching in Parent-Child Interaction Therapy: The Therapist-Parent Interaction Coding System. [2021]This paper describes the initial evaluation of the Therapist-Parent Interaction Coding System (TPICS), a measure of in vivo therapist coaching for the evidence-based behavioral parent training intervention, parent-child interaction therapy (PCIT). Sixty-one video-recorded treatment sessions were coded with the TPICS to investigate (1) the variety of coaching techniques PCIT therapists use in the early stage of treatment, (2) whether parent skill-level guides a therapist's coaching style and frequency, and (3) whether coaching mediates changes in parents' skill levels from one session to the next. Results found that the TPICS captured a range of coaching techniques, and that parent skill-level prior to coaching did relate to therapists' use of in vivo feedback. Therapists' responsive coaching (e.g., praise to parents) was a partial mediator of change in parenting behavior from one session to the next for specific child-centered parenting skills; whereas directive coaching (e.g., modeling) did not relate to change. The TPICS demonstrates promise as a measure of coaching during PCIT with good reliability scores and initial evidence of construct validity.
Treatment fidelity as a predictor of behaviour change in parents attending group-based parent training. [2009]Change in parenting skills, particularly increased positive parenting, has been identified as the key component of successful evidence-based parent training (PT), playing a causal role in subsequent child behaviour change for both prevention and treatment of Conduct Disorder. The amount of change in parenting skills observed after PT varies and may be accounted for by both the content of the programme and by the level of PT implementer process skills. Such variation in implementer skills is an important component in the assessment of treatment fidelity, itself an essential factor in successful intervention outcome.
Video Intervention Therapy for primary caregivers in a child psychiatry unit: a randomized feasibility trial. [2021]During child psychiatry hospitalization, working with the families or attachment figures is a challenge, most of the children who are admitted to these units come from multi-problem families, with limited research in this area. Video feedback (VF) interventions have proved to be a powerful resource to promote parental and child well-being in small children and has been used with parents with a psychiatric condition. Parental Reflective Functioning (PRF) is one of the parental abilities that can be improved with VF and could be especially important in coping with conflict and negative emotions in older children. The aim of this study is to implement Video Intervention Therapy (VIT) to enhance PRF in primary caregivers of inpatient psychiatric children. As there is no published research using VF with parents of children with severe psychopathology in a hospitalized context. This report, then, becomes a much needed pilot study providing evidence for a larger randomized control trial (RCT).
The BabyView camera: Designing a new head-mounted camera to capture children's early social and visual environments. [2023]Head-mounted cameras have been used in developmental psychology research for more than a decade to provide a rich and comprehensive view of what infants see during their everyday experiences. However, variation between these devices has limited the field's ability to compare results across studies and across labs. Further, the video data captured by these cameras to date has been relatively low-resolution, limiting how well machine learning algorithms can operate over these rich video data. Here, we provide a well-tested and easily constructed design for a head-mounted camera assembly-the BabyView-developed in collaboration with Daylight Design, LLC., a professional product design firm. The BabyView collects high-resolution video, accelerometer, and gyroscope data from children approximately 6-30 months of age via a GoPro camera custom mounted on a soft child-safety helmet. The BabyView also captures a large, portrait-oriented vertical field-of-view that encompasses both children's interactions with objects and with their social partners. We detail our protocols for video data management and for handling sensitive data from home environments. We also provide customizable materials for onboarding families with the BabyView. We hope that these materials will encourage the wide adoption of the BabyView, allowing the field to collect high-resolution data that can link children's everyday environments with their learning outcomes.
Photostory-A "Stepping Stone" Approach to Community Engagement in Early Child Development. [2023]Background: Capturing real-life practices through photographs provides an opportunity to create awareness and focus discussions on relevant issues in community. Photographs and narratives also engage decision makers, inspiring changes in policy and practice. Objective: Paper describes development and adaptation of an integrated photostory approach documenting actions and stimulating positive change in Early Child Development (ECD). Methodology: The Photostory method was built through a cyclical process to describe and explore early-childhood practices in central-India through photographs and stories. A systematic format to capture, archive and evaluate photographic material was developed. A standardized rating system was established to monitor levels of, and change in, community practices. We integrated Photostory process into routine visits undertaken during implementation of Stepping-Stones, an ECD intervention program. This paper utilized collected data to explore utility of rating framework to describe and measure behavior and to track change. We explored role of Photostory approach in engaging community in process of stimulating positive ECD experiences. Results: We developed a systematic framework to support data capture, analysis, and data utilization using multistep iterative mixed method process. A total of 161 Photostories were collected (72 at baseline and 89 at endpoint). Using a rating system which measured both the structure of the tasks, and the emotional engagement of the child and parent, many activities and practices observed were evaluated as providing at least an adequate learning space. In exploring change over the implementation process, at endpoint children were more likely to be observed as more engaged in their play activities (p < 0.05). Parental engagement levels remained stable, toward being less actively engaged. At endpoint we observed a trend toward activities being provided for children at a level of difficulty higher than child's level of developmental. The data provided the intervention team with local examples through which to engage parents in discussions on activities that stimulate effective child exploration and learning. We were also able to demonstrate the added value of photographs in stimulating detailed discussion amongst community members on early child development. Conclusion: Photostories can provide a systematic and rigorous methodology to stimulate engagement, monitor and measure change in community-based parenting interventions.
Building Infrastructure for Surveillance of Adverse and Positive Childhood Experiences: Integrated, Multimethod Approaches to Generate Data for Prevention Action. [2023]Adverse and positive childhood experiences have a profound impact on lifespan health and well-being. However, their incorporation into ongoing population-based surveillance systems has been limited. This paper outlines critical steps in building a comprehensive approach to adverse and positive childhood experiences surveillance, provides examples from the Preventing Adverse Childhood Experiences: Data to Action cooperative agreement, and describes improvements needed to optimize surveillance data for action. Components of a comprehensive approach to adverse and positive childhood experiences surveillance include revisiting definitions and measurement, including generating and using uniform definitions for adverse and positive childhood experiences across data collection efforts; conducting youth-based surveillance of adverse and positive childhood experiences; using innovative methods to gather and analyze near real-time data; leveraging available data, including from administrative sources; and integrating data on community- and societal-level risk and protective factors for adverse childhood experiences, including social and health inequities such as racism and poverty, as well as policies and conditions that create healthy environments for children and families. Comprehensive surveillance data on adverse and positive childhood experiences can inform data-driven prevention and intervention efforts, including focusing prevention programming and services to populations in greatest need. Data can be used to evaluate progress in reducing the occurrence of adverse childhood experiences and bolstering the occurrence of positive childhood experiences. Through expansion and improvement in adverse and positive childhood experiences surveillance-including at federal, state, territorial, tribal, and local levels-data-driven action can reduce children's exposure to violence and other adversities and improve lifelong health and well-being.
Research Review: Harnessing the power of individual participant data in a meta-analysis of the benefits and harms of the Incredible Years parenting program. [2021]Parenting programs aim to reduce children's conduct problems through improvement of family dynamics. To date, research on the precise benefits and possible harms of parenting programs on family well-being has been unsystematic and likely to be subject to selective outcome reporting and publication bias. Better understanding of program benefits and harms requires full disclosure by researchers of all included measures, and large enough numbers of participants to be able to detect small effects and estimate them precisely.
Programs for parents of infants and toddlers: recent evidence from randomized trials. [2022]Programs for parents of young children hold considerable promise for improving children's life-course trajectories and for reducing health and development problems and associated costs to government and society. To date, this promise has not been achieved. Fulfilling the potential of parenting interventions will require substantial improvements in current practice for developing and testing such programs. Intervention development will be improved if clinicians and investigators ground parenting interventions in theory and epidemiology; and carefully pilot them to ascertain program feasibility, participant engagement, and behavioral change prior to testing them in randomized trials. Studies of parenting interventions will be improved if they adhere to the highest standards for randomization; if they examine objectively measured outcomes with clear public health relevance; and if they minimize selection factors known to compromise the analysis of data. Policy and practice recommendations for parenting interventions will be improved if they are based upon replicated randomized controlled trials, if the interventions are tested with different populations living in different contexts, and if they are examined in dissemination studies before public investments are made in such programs. Procedures need to be developed to ensure that the essential elements of evidence-based parenting programs can be implemented reliably in a variety of practice settings so that they will produce their intended effects. To date, few programs have met these high programmatic and evidentiary standards, with the result that many large-scale policy initiatives for at-risk parents have failed. Evidence is accumulating, however, that some programs delivered by professionals, especially nurse home visiting programs for pregnant women and parents of young children, produce replicable effects on children's health and development, and that these programs can be reliably reproduced with different populations living in a variety of community settings.
Developing parenting programs to prevent child health risk behaviors: a practice model. [2021]Research indicates that developing public health programs to modify parenting behaviors could lead to multiple beneficial health outcomes for children. Developing feasible effective parenting programs requires an approach that applies a theory-based model of parenting to a specific domain of child health and engages participant representatives in intervention development. This article describes this approach to intervention development in detail. Our presentation emphasizes three points that provide key insights into the goals and procedures of parenting program development. These are a generalized theoretical model of parenting derived from the child development literature, an established eight-step parenting intervention development process and an approach to integrating experiential learning methods into interventions for parents and children. By disseminating this framework for a systematic theory-based approach to developing parenting programs, we aim to support the program development efforts of public health researchers and practitioners who recognize the potential of parenting programs to achieve primary prevention of health risk behaviors in children.
Effects of the Nurturing Parenting Program Nurturing Skills for Families on child safety and permanency. [2023]Many child welfare agencies use the Nurturing Parenting Program Nurturing Skills for Families (NPP) program to strengthen parenting skills. NPP includes a flexible sequence of lessons that are tailored to meet each family's needs.
Experiences of Mothers Participating in a Mother-Child Video Therapy Program. [2023]Responsive and sensitive parenting promotes the development of self-regulation and lowers stress in children, which in turn is associated with greater educational and economic achievement and better physical and emotional health later in life. Dyadic parent-child video-feedback programs can help parents learn effective parenting skills, yet these programs are estimated to retain only about half of eligible participants. Programs vary widely, and little is known about what is valued by parents who do complete these programs. The purpose of this qualitative study was to understand the goals, experiences, and outcomes important to mothers who completed a video-feedback program.
No data, no problem, no action: parenting programs in low-income countries. Making the social-emotional outcomes more visible. [2016]Parenting programs are delivered in many low income countries in an effort to address the effects of insufficient cognitive stimulation, major social-emotional risk factors related to inadequate caregiver sensitivity and responsiveness, maternal depression, violence and biological risk factors. However, the outcomes of these programs are often untested because of methodological limitations in the existing evaluation tools available for cross-cultural research, and especially those related to social-emotional development and functioning.
Impact of a two-generation early education program on parenting processes at age 18. [2014]The Infant Health and Development Program is a two-generation early education model designed to improve parenting competence and child well-being. As part of an 8-site randomized clinical trial involving low birthweight premature children, assessments of children and parents were gathered at the time of program completion (age 3), with follow-up at ages 5, 8, and 18. Two key parenting processes were assessed at age 18 based on theory stipulating the centrality of parenting to long-term development in children. Analyses based on 283 control group and 178 Infant Health and Development Program treatment group participants revealed that treatment group mothers scored higher on one, the provision of enriching experiences. Evidence of sustained impacts on parenting suggests that carefully structured two-generation early education programs may prove good investments for promoting competence and adaptive functioning in high-risk children.