Parent-Mediated Social Training for Developmental Delay

(IA Trial)

Overseen By Rebecca Landa, PhD, CCC-SLP

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Disqualifiers: Head injury, Seizure disorder, Aggression, others

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

Compensation: Varies

Number of Visits: 17

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a parent coaching program called Infant Achievements to determine if it improves social and communication skills in infants showing early signs of developmental delays. Families will either participate in the coaching sessions or receive general caregiver education, with both groups receiving toys designed to support development. The trial seeks families with infants aged 8 to 12 months who have specific developmental concerns, such as language delays, and who primarily speak English at home. As an unphased trial, this study provides families the chance to contribute to important research that could enhance early childhood development strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this protocol is safe for infants and caregivers?

Research has shown that both the Infant Achievements and Caregiver Education methods aim to enhance caregiver-child interactions, aiding child development. This study explores how these methods support infants' social and communication skills.

Specific evidence about the safety of the Infant Achievements method is lacking. However, it involves in-home coaching to enhance play and interaction and is generally considered safe and non-invasive.

The Caregiver Education method has proven helpful in other contexts. For example, group support for caregivers has improved outcomes for children with disabilities, indicating that this method is safe and well-received by both caregivers and children.

Overall, the methods in this study are non-invasive and focus on improving interactions. They are designed to be safe and supportive for both infants and caregivers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for developmental delay because they focus on empowering caregivers to directly support their child's development. Unlike typical therapies that might rely on clinician-led sessions, both the Caregiver Education and Infant Achievements programs involve parents actively in the treatment process. This approach not only fosters a strong parent-child bond but also allows for more frequent, personalized interactions tailored to the child's needs. By equipping parents with the tools and knowledge to nurture their child's growth, these treatments have the potential to create a more sustainable and impactful developmental environment at home.

What evidence suggests that this trial's treatments could be effective for developmental delay?

Research has shown that early support can greatly aid children's development. In this trial, participants will be randomized into one of two programs. The Infant Achievements program, provided to some participants, teaches caregivers how to support their children and can enhance kids' social and communication skills. Studies have found that children in similar programs performed better intellectually as they grew older.

The Caregiver Education program, offered to other participants, focuses on teaching caregivers to be more sensitive and responsive, supporting children's growth. Research indicates that higher levels of caregiver education and activities at home correlate with better development scores in children. Overall, these programs aim to improve caregiver-child interactions, which are essential for a child's development. ^{6 7 8 9 10}

Who Is on the Research Team?

Rebecca Landa, PhD, CCC-SLP

Principal Investigator

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Are You a Good Fit for This Trial?

This trial is for infants aged 8-12 months who may be at risk for autism or developmental delays, and their caregivers. Infants must show certain signs of communication or social challenges. Caregivers should primarily speak English at home. Infants with hearing/visual impairments, genetic disorders, low birth weight/prematurity, or severe trauma are excluded.

Inclusion Criteria

My child is between 8 and 12 months old.

Children must receive an AOSI concern score ≥7 OR a T-score of ≤39 on either the Mullen Receptive Language or Expressive Language subscale OR Score in the Concern range on either the Composite or Total Score of the parent-completed Communication and Symbolic Behavior Scales Developmental Profile (CSBS DP) Infant-Toddler Checklist

Exclusion Criteria

Any severe birth trauma

Cannot be living in foster care

I have a hearing or visual impairment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Infant Achievements coaching or Caregiver Education intervention

8 weeks

17 sessions (in-home and phone)

Follow-up

Participants are monitored for changes in parent and child behavior post-intervention

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Caregiver Education
• Infant Achievements

Trial Overview The study tests a caregiver coaching program called Infant Achievements (IA) against a no-coaching education group (CE). It aims to improve how caregivers interact during play and enhance the infant's social and communication behaviors through direct comparison in a randomized controlled setup.

How Is the Trial Designed?

Group I: Infant Achievements Experimental Treatment 1 Intervention

Families randomized to the IA condition will receive 17 in-home sessions. These include a one-time start up session followed by twice-weekly visits in which they will be coached on how to implement the IA strategies. Families will receive a set of developmentally appropriate toys.

Group II: Caregiver Education Experimental Treatment 1 Intervention

In this condition, parents will receive 17 sessions with a trained study team member focused on promoting child development and well-being. Sessions include a one-time start-up visit followed by one in-home visit and one phone contact per week. Families will receive a set of developmentally appropriate toys.

Who Is Running the Clinical Trial?

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Lead Sponsor

Trials

93

Recruited

25,200+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

A training course for parents of children with autism spectrum disorder significantly improved parents' use of facilitative communication strategies and increased their children's vocabulary size after 7 months.

The study involved 51 children aged 24 to 48 months and demonstrated that the intervention was well-received, indicating its potential effectiveness in enhancing communication skills for both parents and children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled trial of a training course for parents of children with suspected autism spectrum disorder. McConachie, H., Randle, V., Hammal, D., et al.[2022]

A new online program for caregivers of children with Autism Spectrum Disorder (ASD) was developed to help parents learn effective interventions, and about two-thirds of the enrolled parents completed all 14 modules.

Parents found the program to be clear, enjoyable, and useful, reporting improvements in their children's skills and behavior, highlighting its potential as a valuable resource despite some barriers to completion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Acceptability of a New Program for Caregivers of Children with Autism Spectrum Disorder: Online Parent Training in Early Behavioral Intervention. Dai, YG., Thomas, RP., Brennan, L., et al.[2021]

In a study involving 15 families, parents who participated in either the Parents as Teachers or Parents as Advocates training programs showed significant improvements in their specific knowledge and skills related to behavior modification and advocacy after the training.

The results indicated that the gains in knowledge and skills were specific to the training received, suggesting that the programs were effective and that nonspecific factors had little impact on the outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training parents of retarded children: program-specific outcomes. Baker, BL., Brightman, RP.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8752997/

Effectiveness of Care for Child Development Program on ... Conclusion: The results showed that the care for child development program has positive effects on sensitivity and responsiveness skills of mothers of children ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1875957225001044

Effectiveness of early intervention and prediction ... This study investigated the correlation between developmental outcomes and child-level factors by using serial MDA data, and we also aimed to ...

3. link.springer.com link.springer.com/article/10.1007/s13158-024-00398-x

The Relations Between Caregiver Education, Home ... Results showed that higher levels of home stimulation and caregiver education predicted significantly higher child development scores in the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7615939/

Practices and outcomes of responsive caregiving on child ... Responsive caregiving (RC) leads to positive outcomes in children, including secure attachment with caregivers, emotional regulation, positive social ...

5. researchgate.net researchgate.net/publication/388851003_Correlation_of_Responsive_Caregiving_with_Child_Development

(PDF) Correlation of Responsive Caregiving with Child ... This study found 7 children (10.5%) with developmental delay. A significant relationship was found between parenting responsiveness and general ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11009896/

Group-based caregiver support interventions for children ... Caregiver support group interventions provide a promising avenue of improving caregiver and child outcomes for children living with disability in LMIC settings.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6899448/

Neurodevelopmental delay: Case definition & guidelines for ... Data from 2009 in Australia estimated 7.0% of children ages 0–14 years met criteria for a broader definition of disability encompassing developmental delays, ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0891422224001471

Needs of children with neurodevelopmental disorders and ... Behavioural issues impacted families' security and stability: 64 % of caregivers faced greater challenges than anticipated with their children's behavioural ...

9. cdc.gov cdc.gov/pcd/issues/2024/24_0142.htm

Trends in Mental, Behavioral, and Developmental ... From 2016 through 2021, MBDD prevalence among children aged 3 to 17 years increased from 25.3% to 27.7%; increases were specific to anxiety, depression, ...

10. researchgate.net researchgate.net/publication/383913424_The_Relations_Between_Caregiver_Education_Home_Stimulation_and_Children's_Developmental_Outcomes_Research_in_Majority_World_Countries

(PDF) The Relations Between Caregiver Education, Home ... Caregiver education and home stimulation have shown positive associations with children's developmental outcomes in early childhood in ...