Parenting Programs for Childhood Development

(SEAL Trial)

Overseen By Elizabeth Backus, B.A.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Oregon

Must not be taking: Psychoactive medications

Disqualifiers: Neurological disorders, Brain trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

Duration: 10 weeks

160 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{11 12 13 14 15}

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.

Research Team

Philip A Fisher, Ph.D.

Principal Investigator

University of Oregon

Eligibility 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 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.

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

Treatment Details

Interventions

• Filming Interactions to Nurture Development
• The Healthy Toddler Program

Trial Overview 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.

Participant Groups

Group I: Filming Interactions to Nurture Development (FIND) Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

University of Oregon

Lead Sponsor

Trials

91

Recruited

46,700+

Findings from Research

The Video Interaction Project (VIP) significantly improved parenting practices and reduced parenting stress among 99 Latino children at risk of developmental delays, indicating its effectiveness in promoting early child development.

Children who participated in VIP were more likely to achieve normal cognitive development and less likely to experience developmental delays compared to those in the control group, highlighting the program's positive impact on at-risk preschoolers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of videotaped interactions during pediatric well-child care: impact at 33 months on parenting and on child development. Mendelsohn, AL., Valdez, PT., Flynn, V., et al.[2021]

The Primary Care-Video Intervention Therapy (PC-VIT) effectively supported parents of a Small for Gestational Age (SGA) infant, helping to reduce maternal anxiety and improve parental recognition of the infant's developmental skills.

Implementing PC-VIT in pediatric care can mitigate the negative effects of growth vulnerabilities on the parent-child relationship and promote better socio-emotional development in infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Primary Care-Video Intervention Therapy for Growth-Vulnerable Infants. A Case Study. Sacchi, C., Facchini, S., Downing, G., et al.[2020]

The Therapist-Parent Interaction Coding System (TPICS) effectively captures various coaching techniques used by therapists during Parent-Child Interaction Therapy (PCIT), based on an analysis of 61 video-recorded sessions.

The study found that responsive coaching techniques, such as providing praise, helped improve parents' skills between sessions, while directive coaching methods did not show the same effect, indicating the importance of tailored feedback in enhancing parenting behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Key to Effective Coaching in Parent-Child Interaction Therapy: The Therapist-Parent Interaction Coding System. Barnett, ML., Niec, LN., Acevedo-Polakovich, ID.[2021]

The Leader Observation Tool effectively predicts changes in parenting skills after participating in the Incredible Years parent training program, highlighting the importance of implementer skills in achieving positive outcomes.

Higher treatment fidelity in delivering parent training not only maintains the intervention's effectiveness but also leads to improved parenting behaviors, which subsequently result in better child behavior outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment fidelity as a predictor of behaviour change in parents attending group-based parent training. Eames, C., Daley, D., Hutchings, J., et al.[2009]

The study implemented Video Intervention Therapy (VIT) to enhance Parental Reflective Functioning (PRF) in caregivers of children hospitalized for severe psychiatric issues, showing that the intervention was feasible and well-accepted by participants and therapists.

With a compliance rate of 85% in the VIT group and positive indications for improving both parental and child mental health outcomes, this pilot study supports the need for a larger randomized control trial to further evaluate VIT's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video Intervention Therapy for primary caregivers in a child psychiatry unit: a randomized feasibility trial. Leyton, F., Olhaberry, M., Morán, J., et al.[2021]

The BabyView is a new head-mounted camera designed for infants aged 6-30 months that captures high-resolution video along with motion data, providing a comprehensive view of their everyday experiences.

This innovative device aims to standardize data collection in developmental psychology, allowing for better comparisons across studies and enhancing the use of machine learning algorithms to analyze rich video data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The BabyView camera: Designing a new head-mounted camera to capture children's early social and visual environments. Long, B., Goodin, S., Kachergis, G., et al.[2023]

The Photostory approach effectively documented and evaluated early childhood practices in central India, resulting in the collection of 161 Photostories that helped engage the community in discussions about Early Child Development (ECD).

At the end of the intervention, children showed increased engagement in play activities, indicating positive changes in ECD practices, while parental engagement levels remained stable, suggesting areas for further improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photostory-A "Stepping Stone" Approach to Community Engagement in Early Child Development. Gaidhane, A., Holding, P., Shah, M., et al.[2023]

A comprehensive approach to monitoring adverse and positive childhood experiences is essential for improving children's health and well-being, which includes standardizing definitions and measurements across data collection efforts.

Enhanced surveillance can lead to data-driven prevention strategies that target at-risk populations, ultimately reducing exposure to violence and adversities while promoting positive experiences for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building Infrastructure for Surveillance of Adverse and Positive Childhood Experiences: Integrated, Multimethod Approaches to Generate Data for Prevention Action. Anderson, KN., Swedo, EA., Clayton, HB., et al.[2023]

The Incredible Years parenting program, studied in 1,799 participants across 14 trials, effectively improves parenting practices and reduces children's conduct problems and ADHD symptoms, with no evidence of harmful effects.

While the program enhances certain family dynamics, it does not significantly improve children's emotional problems or parental mental health, indicating its benefits are somewhat limited to specific areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research Review: Harnessing the power of individual participant data in a meta-analysis of the benefits and harms of the Incredible Years parenting program. Leijten, P., Gardner, F., Landau, S., et al.[2021]

Parenting intervention programs have the potential to significantly improve children's health and development, but many existing programs have not met the necessary standards for effectiveness, leading to failures in large-scale initiatives.

Evidence suggests that certain programs, particularly nurse home visiting for pregnant women and young parents, can produce consistent positive outcomes for children's health and development across diverse populations and settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programs for parents of infants and toddlers: recent evidence from randomized trials. Olds, DL., Sadler, L., Kitzman, H.[2022]

Developing effective public health programs that modify parenting behaviors can lead to significant health benefits for children, emphasizing the importance of a theory-based model of parenting.

The article outlines an eight-step intervention development process and highlights the integration of experiential learning methods, providing a structured framework for public health researchers to create impactful parenting programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing parenting programs to prevent child health risk behaviors: a practice model. Jackson, C., Dickinson, DM.[2021]

Children whose families completed the Nurturing Parenting Program (NPP) were significantly less likely to face child welfare investigations or removals, indicating the program's effectiveness in improving child safety outcomes.

In contrast, simply being referred to NPP did not show any significant impact, highlighting the importance of program completion for achieving positive results in child welfare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the Nurturing Parenting Program Nurturing Skills for Families on child safety and permanency. Gross, M., Bhagwat, A., Cole, R.[2023]

Mothers who completed a video-feedback program reported that their main goals were to better understand their child and strengthen their relationship, leading to increased confidence in their parenting skills.

Key elements that contributed to their positive experiences included receiving supportive feedback from therapists, spending dedicated time with their infants, and learning through videotaped sessions, which resulted in improved parenting strategies and better child behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of Mothers Participating in a Mother-Child Video Therapy Program. Hackley, B., Hammer, M., Barnhart, E., et al.[2023]

The Learning Through Play (LTP) parenting program, implemented in 11 low-income countries, aims to enhance parental knowledge and practices for the early development of children aged 0-6 years.

This study demonstrates that organizing qualitative data from focus groups can effectively highlight the social-emotional outcomes of parenting programs, which have often been neglected in previous evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No data, no problem, no action: parenting programs in low-income countries. Making the social-emotional outcomes more visible. Tinajero, AR., Cohen, NJ., Ametorwo, S.[2016]

The Infant Health and Development Program, evaluated in a randomized clinical trial with 461 participants, showed that mothers in the treatment group provided significantly more enriching experiences for their children by age 18 compared to the control group.

Sustained improvements in parenting practices indicate that two-generation early education programs can effectively enhance parenting competence and support the long-term development of high-risk children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a two-generation early education program on parenting processes at age 18. Bradley, RH., Whiteside-Mansell, L., Casey, PH., et al.[2014]

References

1. United States pubmed.ncbi.nlm.nih.gov

Use of videotaped interactions during pediatric well-child care: impact at 33 months on parenting and on child development. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Primary Care-Video Intervention Therapy for Growth-Vulnerable Infants. A Case Study. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Assessing the Key to Effective Coaching in Parent-Child Interaction Therapy: The Therapist-Parent Interaction Coding System. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Treatment fidelity as a predictor of behaviour change in parents attending group-based parent training. [2009]

5. England pubmed.ncbi.nlm.nih.gov

Video Intervention Therapy for primary caregivers in a child psychiatry unit: a randomized feasibility trial. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

The BabyView camera: Designing a new head-mounted camera to capture children's early social and visual environments. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Photostory-A "Stepping Stone" Approach to Community Engagement in Early Child Development. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Building Infrastructure for Surveillance of Adverse and Positive Childhood Experiences: Integrated, Multimethod Approaches to Generate Data for Prevention Action. [2023]

9. England pubmed.ncbi.nlm.nih.gov

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]

10. England pubmed.ncbi.nlm.nih.gov

Programs for parents of infants and toddlers: recent evidence from randomized trials. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Developing parenting programs to prevent child health risk behaviors: a practice model. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Effects of the Nurturing Parenting Program Nurturing Skills for Families on child safety and permanency. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Experiences of Mothers Participating in a Mother-Child Video Therapy Program. [2023]

14. England pubmed.ncbi.nlm.nih.gov

No data, no problem, no action: parenting programs in low-income countries. Making the social-emotional outcomes more visible. [2016]

15. United States pubmed.ncbi.nlm.nih.gov

Impact of a two-generation early education program on parenting processes at age 18. [2014]