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

Primary Purpose

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

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Infant Achievements
Caregiver Education (CE)
Sponsored by
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Younger Sibling of Child With Autism Spectrum Disorder focused on measuring infant, play, parents

Eligibility Criteria

8 Months - 12 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kennedy Krieger Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Infant Achievements

Caregiver Education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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 in child communication and social engagement sample during the Parent-Child Play Sample
This outcome will be coded from the Parent-Child Play Sample

Secondary Outcome Measures

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 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 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

Full Information

First Posted
October 19, 2017
Last Updated
December 5, 2022
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT03404505
Brief Title
Effects of a Short-term Parent Mediated Social Training on Developmental Trajectories in Infants
Acronym
IA
Official Title
Effects of a Short-term Parent Mediated Social Training on Developmental Trajectories in Infants
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 3, 2017 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Younger Sibling of Child With Autism Spectrum Disorder, Signs of Developmental Delay, Signs of Communication Delay, Signs of Social Delay
Keywords
infant, play, parents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Infant Achievements
Arm Type
Experimental
Arm Description
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.
Arm Title
Caregiver Education
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Infant Achievements
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Caregiver Education (CE)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in parent behavior during the Parent-Child Play Sample
Description
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
Time Frame
Change from behavior at Baseline to behavior at 8 weeks post-baseline, and from Baseline to 8 weeks post-intervention
Title
Change in child communication and social engagement sample during the Parent-Child Play Sample
Description
This outcome will be coded from the Parent-Child Play Sample
Time Frame
Change from behavior at Baseline to behavior at 8 weeks post-baseline, and from Baseline to 8 weeks post-intervention
Secondary Outcome Measure Information:
Title
Change in scores on the Mullen Scales of Early Learning Receptive and Expressive Language Raw Scores
Description
Receptive Language score (score range 0-48); Expressive Language Score (score range 0-50); higher scores indicate better outcome for both scales
Time Frame
Change from Baseline to 8 weeks post-baseline, and from Baseline to 8 weeks post-intervention
Title
Change in scores on the MacArthur-Bates Communication Development Inventory
Description
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
Time Frame
Change from Baseline to 8 weeks post-baseline, and from Baseline to 8 weeks post-intervention
Title
Change in scores on the CSBS Behavior Sample
Description
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
Time Frame
Change from Baseline to 8 weeks post-baseline, and from Baseline to 8 weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Landa, PhD, CCC-SLP
Organizational Affiliation
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kennedy Krieger Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21211
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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