Parental Education for Child Development

(CANDO Trial)

Recruiting at 1 trial location

Overseen By Neeha Shrestha, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Preterm birth, Dysphagia, Specialized diet, others

Compensation: Varies

Number of Visits: 8

1800 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on parental education for child development, so it's unlikely to require changes to your medications.

What data supports the effectiveness of the treatment Parental Education for Child Development?

Research shows that parenting programs can improve children's behavior and development. For example, a study found that a parenting program in Head Start centers led to better parenting practices and improved children's social skills and behavior. Another study showed that parent interventions helped improve behavior in children after a traumatic brain injury. ^{1 2 3 4 5}

Is the Parental Education for Child Development treatment safe for children?

The safety of treatments in children is carefully regulated, with additional protections to limit risks. However, many drugs and treatments have not been fully studied for safety in children, and ongoing efforts aim to improve this data. ^{6 7 8 9 10}

How does the 'Control' treatment in the Parental Education for Child Development trial differ from other treatments?

The 'Control' treatment in this trial refers to standard care or a placebo, which means it serves as a baseline to compare the effects of parental education interventions. Unlike other treatments that actively involve educational components or specialist support, the control group does not receive these additional resources, making it unique in its role as a comparison point to evaluate the effectiveness of new interventions. ^{11 12 13 14 15}

What is the purpose of this trial?

The overall goal of this study is to understand how common conditions in childhood develop and if by providing specific health education and resources to parents/caregivers we can promote healthy development. This study will provide information and instruction on several aspects of infant care including, sleep, nutrition, building a healthy relationship with your baby, and healthy screen time use.

Research Team

Ruchi S Gupta, MD MPH

Principal Investigator

Northwestern University Feinberg School of Medicine

Eligibility Criteria

This trial is for parents/guardians of infants under 26 weeks old who are in good health and can give informed consent in English or Spanish. The family should be willing to follow the study's procedures, not planning to move away before the child turns one year old, and open to being randomly assigned to a group.

Inclusion Criteria

Stated willingness to comply with all study procedures and availability for the duration of the study

Parent/guardian(s) must understand and provide informed consent

I was assigned male or female at birth.

Exclusion Criteria

I am unwilling to introduce peanut, milk, egg, or cashew into my diet.

I have a health condition that requires a special diet.

I can provide informed consent in English or Spanish.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

The intervention group receives education about nutrition, resources, and specific instructions on promoting healthy development of their infant.

36 months

4 visits (in-person)

Control

The control group receives specific instructions on promoting healthy development of their infant, including guidance regarding infant sleep, screen time, and building healthy relationships.

36 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Control
• Intervention

Trial Overview The study aims to see if providing health education on infant care (like sleep habits, nutrition, bonding with your baby, and screen time) can influence childhood development positively. Parents will be split into two groups: one receiving this intervention and another serving as a control.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

The intervention group will receive education about nutrition, resources, and specific instructions on promoting healthy development of their infant, including guidance regarding infant sleep, screen time, and building healthy relationships.

Group II: Control Placebo Group 1 Intervention

The control group will receive specific instructions on promoting healthy development of their infant, including guidance regarding infant sleep, screen time, and building healthy relationships.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Food Allergy Research & Education

Collaborator

Trials

6

Recruited

31,100+

Findings from Research

A cluster-randomized controlled trial in Bangladesh involving 419 children showed that a group-based parenting program significantly improved child cognition, language, and motor development, with effect sizes ranging from 0.52 to 0.85 SDs.

The intervention, delivered by government health staff in community clinics, did not have a significant impact on children's growth, but it demonstrated the potential for scalable parenting programs to enhance child development outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating a Group-Based, Early Childhood Parenting Intervention Into Primary Health Care Services in Rural Bangladesh: A Cluster-Randomized Controlled Trial. Mehrin, SF., Hasan, MI., Tofail, F., et al.[2023]

A parenting program involving 394 Head Start mothers led to significant improvements in parenting behaviors, with mothers in the intervention group using less harsh discipline and being more positive and competent compared to those in the control group.

Children of mothers who participated in the program showed fewer conduct problems and more positive behaviors, and these improvements were largely maintained one year later.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing conduct problems in Head Start children: strengthening parenting competencies. Webster-Stratton, C.[2022]

A systematic review of seven randomized controlled trials found that parent interventions significantly improve child behavior outcomes following pediatric traumatic brain injury (TBI).

Factors such as the child's age, baseline behavior, sociodemographics, and parent mental health can influence the effectiveness of these interventions, highlighting the importance of considering these variables in treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent Interventions Improve Behavior After Pediatric Traumatic Brain Injury: A Systematic Review and Meta-analysis. Cermak, CA., McCabe, SA., Kuchurean, B., et al.[2023]

A follow-up study one year after a parent-child interaction training program showed that while parents did not report differences between treatment and control groups, teachers rated children in the treatment group as significantly better in managing attention deficit and hyperactivity symptoms.

Improvements in children's classroom behavior were linked to positive changes in parental behavior during the intervention, suggesting that the training had a lasting impact on both parent and child interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-up one year after parent-child interaction training: effects on behavior of preschool children. Strayhorn, JM., Weidman, CS.[2007]

The Chicago Parent Program (CPP) was found to be as effective as Parent-Child Interaction Therapy (PCIT) in reducing behavior problems in young children, with both methods showing significant improvements based on the Child Behavior Checklist scores.

CPP is more cost-effective and requires less time to complete than PCIT, making it a viable option for parents of young children in low-income settings, with average treatment costs of $1,413 for CPP compared to $2,151 for PCIT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Preschool Behavior Problems in an Urban Mental Health Clinic: A Pragmatic, Non-Inferiority Trial. Gross, D., Belcher, HME., Budhathoki, C., et al.[2023]

Out of 266 pediatric products studied between 2012 and 2018, 25% were involved in 96 placebo-controlled trials, demonstrating a significant use of this rigorous method in pediatric drug development.

Many of these trials implemented risk mitigation strategies, such as using placebo as an add-on to effective therapies and including rescue therapy, ensuring compliance with regulations that protect children in clinical research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethical Considerations for Pediatric Placebo-Controlled Trials: FDA Outcomes and Perspectives. Momper, JD., Green, DJ., Park, K., et al.[2021]

In a two-year study involving 200 children from low-income families in Brazil, fluoride varnish (22,600 ppm) did not show a significant difference in the development of new dental caries compared to a placebo varnish, with 36% of the fluoride group developing new dentinal lesions versus 47% in the placebo group.

The fluoride varnish was found to be safe and well-tolerated, with only minor complaints about taste and appearance, suggesting that while the study did not find significant efficacy, the use of fluoride varnish is generally acceptable for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluoride varnish applications and caries incidence in pre-schoolers. Keightley, AJ., Taylor, GD.[2018]

The study analyzed 71 drug products under the FDA's pediatric regulations from 2012 to 2020, revealing that pediatric placebo response rates can vary significantly compared to adults, complicating the evaluation of treatment efficacy.

In trials with identical designs for both pediatric and adult populations, the placebo response in children was sometimes higher and sometimes lower than in adults, indicating the need for further research into the factors influencing these differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric and Adult Placebo Response Rates in Placebo-Controlled Clinical Trials Submitted to the US Food and Drug Administration 2012-2020. Park, K., Tran, NK., Momper, JD., et al.[2022]

Only about one-third of prescription drugs used in children have been adequately studied for safety and efficacy in pediatric populations, highlighting a significant gap in medical research.

Recent efforts by the FDA to improve pediatric drug research have had mixed results, indicating a need for better practices and innovative solutions to ensure children receive safe and effective medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Just a spoonful of sugar: drug safety for pediatric populations. Noah, BA.[2017]

The USFDA's Final Rule of 1997, effective April 1999, mandates that pharmaceutical companies must submit pediatric data for medications, addressing the historical lack of adequate studies in children and improving safety in prescribing practices.

The establishment of Pediatric Pharmacology Research Units by the NIH aims to enhance collaboration in pediatric research, facilitating the proper labeling of medications for children and ensuring that caregivers are informed about the risks and benefits of treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical pharmacology research in the pediatric patient: the challenge continues. Ten Eick AP, ., Reed, MD.[2019]

Healthy Steps (HS) significantly improves pediatric primary care by integrating a child development specialist into the healthcare team, leading to more preventive and developmental services for families, as evidenced by a study involving 3737 families.

Families participating in HS reported higher satisfaction with their pediatric care and better parenting practices, such as adherence to health visits and nutritional practices, while maintaining a cost-effective approach compared to other early childhood interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy Steps: a case study of innovation in pediatric practice. Zuckerman, B., Parker, S., Kaplan-Sanoff, M., et al.[2006]

The Video Interaction Project (VIP) showed a moderate positive impact on cognitive and language development in Latino children at risk of developmental delay, particularly for those whose mothers had between seventh and 11th grade education, with effect sizes of approximately 0.75 SD for cognitive development and 0.5 SD for expressive language.

However, the program had little to no impact on children whose mothers had sixth grade or lower education, indicating that maternal education level plays a significant role in the effectiveness of the VIP intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of videotaped interactions during pediatric well-child care to promote child development: a randomized, controlled trial. Mendelsohn, AL., Dreyer, BP., Flynn, V., et al.[2021]

Parents play a crucial role in their children's health and development, and physicians can support them by promoting evidence-based interventions that enhance child development.

Four key strategies identified for improving childhood outcomes include fostering emotional awareness, encouraging reading, implementing appropriate discipline, and providing access to preschool programs with play opportunities, all of which can create nurturing environments for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social paediatrics and early child development - the practical enhancements: Part 2. Bertrand, J., Williams, R., Ford-Jones, L.[2021]

The 'parent education package' (PEP) was well-received by parents but did not lead to any significant changes in children's behavior, indicating a lack of efficacy in preventing behavior problems.

The study suggests that future prevention programs might be more effective if they focus on promoting positive perceptions of children among parents rather than just providing educational materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent education in preventing behaviour problems. Hewitt, K.[2004]

In a review of 760 publications, 79.41% of studies treated breastfed children as the intervention group, suggesting a bias that positions breastfeeding as a health intervention rather than a standard feeding method.

This approach may misrepresent breastfeeding as an optional choice with benefits, while formula-feeding is implied as the norm, leading to potential misinterpretation of the health implications of feeding practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breastfeeding: A standard or an intervention? Review of systematic reviews. Dimnjakovic, J., Poljicanin, T., Svajda, M.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Integrating a Group-Based, Early Childhood Parenting Intervention Into Primary Health Care Services in Rural Bangladesh: A Cluster-Randomized Controlled Trial. [2023]

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

Preventing conduct problems in Head Start children: strengthening parenting competencies. [2022]

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

Parent Interventions Improve Behavior After Pediatric Traumatic Brain Injury: A Systematic Review and Meta-analysis. [2023]

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

Follow-up one year after parent-child interaction training: effects on behavior of preschool children. [2007]

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

Reducing Preschool Behavior Problems in an Urban Mental Health Clinic: A Pragmatic, Non-Inferiority Trial. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Ethical Considerations for Pediatric Placebo-Controlled Trials: FDA Outcomes and Perspectives. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Fluoride varnish applications and caries incidence in pre-schoolers. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Pediatric and Adult Placebo Response Rates in Placebo-Controlled Clinical Trials Submitted to the US Food and Drug Administration 2012-2020. [2022]

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

Just a spoonful of sugar: drug safety for pediatric populations. [2017]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical pharmacology research in the pediatric patient: the challenge continues. [2019]

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

Healthy Steps: a case study of innovation in pediatric practice. [2006]

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

Use of videotaped interactions during pediatric well-child care to promote child development: a randomized, controlled trial. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Social paediatrics and early child development - the practical enhancements: Part 2. [2021]

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

Parent education in preventing behaviour problems. [2004]

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

Breastfeeding: A standard or an intervention? Review of systematic reviews. [2021]