Effects of a Short-term Parent Mediated Social Training on Developmental Trajectories in Infants

Signs of Communication Delay Clinical Trial

— IA  

Official title:

Effects of a Short-term Parent Mediated Social Training on Developmental Trajectories in Infants

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03404505
• Other study ID #: IRB00065698
• Secondary ID: R21DC015846
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 3, 2017
• Est. completion date: November 2024

Study information

• Verified date: December 2023
• Source: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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. Parents in the IA group will be coached, at home twice a week, to implement the intervention by trained research staff. Parents in the CE group will be taught about child development and well-being in their home, weekly, with a weekly follow-up phone call by trained research staff. In both groups: Videotaped caregiver-child interaction data will be gathered in the home. Baseline, post-treatment and follow-up measures will also be collected at the investigators' child development research center.

Families with children between the ages of 8 and 12 months with developmental concerns may be eligible to participate. Developmental concerns are defined as infrequent production of specific communication or social behaviors, or in immature or qualitatively atypical forms. These concerns will be documented via the Autism Observation Scale for Infants, Communication and Symbolic Behavior Scale (CSBS) Infant-Toddler Checklist, and/or Mullen Scales of Early Learning. Recruitment will occur from the Kennedy Krieger Institute (KKI), community agencies, and community events. Recruitment flyers will be distributed within those programs. In addition, a social media blurb will be placed on the KKI and other relevant groups' Facebook pages, KKI Center for Autism and Related Disorders newsletter, KKI websites, and may be sent to relevant local newsletters/magazines for families of young children.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Months to 12 Months

Eligibility

Inclusion Criteria:

• Child participants must be between the ages of 8 months and 12 months at the beginning of the study.

• Family must speak English at least 75% in the home.

• 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:

• History of head injury, seizure disorder, severe aggression or self-injurious behavior, prenatal illicit drug or excessive alcohol exposure.

• Any hearing or visual impairment

• Any severe birth trauma

• Any birth defects or genetic disorders

• Gestational age < 35 weeks and/or Birth weight less than 1,500g

• Cannot be living in foster care.

• Location of in-home visits >35 miles of the Center for Autism and Related Disorders

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Signs of Communication Delay
• Signs of Developmental Delay
• Signs of Social Delay
• Younger Sibling of Child With Autism Spectrum Disorder

Intervention

Behavioral:
• Infant Achievements
Play-based intervention for caregivers and infants. The efficacy of the Infant Achievements intervention for improving communication and social behavior in infants who are at risk for communication, social, or developmental delay.
• Caregiver Education (CE)
Parents in the CE group will be taught about child development and well-being in their home, weekly, with a weekly follow-up phone call by trained research staff.

Locations

Country	Name	City	State
United States	Kennedy Krieger Institute	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in parent behavior during the Parent-Child Play Sample	This measure is a natural observation of parent and child unstructured playing, and will be used to assess change in caregiver's use of child-responsive engagement strategies	Change from behavior at Baseline to behavior at 8 weeks post-baseline, and from Baseline to 8 weeks post-intervention
Primary	Change in child communication and social engagement sample during the Parent-Child Play Sample	This outcome will be coded from the Parent-Child Play Sample	Change from behavior at Baseline to behavior at 8 weeks post-baseline, and from Baseline to 8 weeks post-intervention
Secondary	Change in scores on the Mullen Scales of Early Learning Receptive and Expressive Language Raw Scores	Receptive Language score (score range 0-48); Expressive Language Score (score range 0-50); higher scores indicate better outcome for both scales	Change from Baseline to 8 weeks post-baseline, and from Baseline to 8 weeks post-intervention
Secondary	Change in scores on the MacArthur-Bates Communication Development Inventory	Number of words understood (range 0-396); Number of words produced (0-396); Total actions & gestures (0-63); higher scores indicate better outcomes for all scales	Change from Baseline to 8 weeks post-baseline, and from Baseline to 8 weeks post-intervention
Secondary	Change in scores on the CSBS Behavior Sample	Frequency of initiation of joint attention; frequency of communicative consonants (range 0-6), gestures (range 0-6) and words (range (0-6); higher scores indicate greater outcome on all scales	Change from Baseline to 8 weeks post-baseline, and from Baseline to 8 weeks post-intervention