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

64 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is being done to examine the feasibility and impact of the Infant Achievements caregiver coaching treatment on caregiver child-engagement strategies used during play with their infant. The investigators will examine effects on infants' social and communication behavior. This randomized controlled trial will compare caregivers and infants in the Infant Achievements (IA) coaching group to caregivers and infants in the Caregiver Education (CE) no-coaching group. A total of 64 eligible participants (16 children plus their caregiver per group) will participate in the study.

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 data supports the effectiveness of the treatment Caregiver Education, Infant Achievements for developmental delay?

Research shows that parent training programs, like the one in the study 'Early effects of responsivity education/prelinguistic milieu teaching,' can help reduce parenting stress and improve communication skills in children with developmental delays. Additionally, the study 'Preliminary evaluation of a low-intensity parent training program' found that training parents can enhance their ability to support their children's language development. ^{1 2 3 4 5}

Is parent-mediated social training safe for children with developmental delays?

The available studies on parent-mediated social training programs, such as the WHO-Caregiver Skills Training and other similar interventions, suggest that these programs are generally safe. Caregivers reported the programs as acceptable and beneficial, with no safety concerns noted in the research. ^{2 6 7 8 9}

How is the Parent-Mediated Social Training for Developmental Delay treatment different from other treatments?

This treatment is unique because it involves training parents to help their children with developmental delays, focusing on improving social skills through caregiver education and infant achievements. Unlike other treatments that may rely on direct therapy from specialists, this approach empowers parents to be active participants in their child's development, potentially leading to more sustainable improvements in behavior and interaction. ^{2 6 8 10 11}

Research Team

Rebecca Landa, PhD, CCC-SLP

Principal Investigator

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

Eligibility Criteria

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.

My family speaks English at home most of the time.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Preliminary evaluation of a low-intensity parent training program on speech-language stimulation for children with language delay. [2019]

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

Early effects of responsivity education/prelinguistic milieu teaching for children with developmental delays and their parents. [2011]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Training parents of retarded children: program-specific outcomes. [2019]

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

A controlled trial of a training course for parents of children with suspected autism spectrum disorder. [2022]

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

Training graduate students in parent conference skills. [2019]

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

World Health Organisation-Caregiver Skills Training (WHO-CST) Program: Feasibility of Delivery by Non-Specialist Providers in Real-world Urban Settings in India. [2023]

7. United States 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. [2021]

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

Parent education project. III: Increasing affection and responsivity in developmentally handicapped mothers: component analysis, generalization, and effects on child language. [2019]

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

A participant modeling procedure to train parents of developmentally disabled infants. [2004]

10. Switzerland pubmed.ncbi.nlm.nih.gov

The Efficacy of Parent Training Interventions with Parents of Children with Developmental Disabilities. [2022]

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

Parent training for young children with developmental disabilities: randomized controlled trial. [2022]