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

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ClinicalTrials.gov Identifier: NCT03404505
Recruitment Status : Recruiting
First Posted : January 19, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

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.

Condition or disease Intervention/treatment Phase
Younger Sibling of Child With Autism Spectrum Disorder Signs of Developmental Delay Signs of Communication Delay Signs of Social Delay Behavioral: Infant Achievements Behavioral: Caregiver Education (CE) Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Short-term Parent Mediated Social Training on Developmental Trajectories in Infants
Actual Study Start Date : November 3, 2017
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: Infant Achievements
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.
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.

Experimental: Caregiver Education
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.
Behavioral: 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.




Primary Outcome Measures :
  1. Change in parent behavior during 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 ]
    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

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


Secondary Outcome Measures :
  1. Change in scores on the Mullen Scales of Early Learning Receptive and Expressive Language Raw Scores [ Time Frame: Change from Baseline to 8 weeks post-baseline, and from Baseline to 8 weeks post-intervention ]
    Receptive Language score (score range 0-48); Expressive Language Score (score range 0-50); higher scores indicate better outcome for both scales

  2. Change in scores on the MacArthur-Bates Communication Development Inventory [ Time Frame: Change from Baseline to 8 weeks post-baseline, and from Baseline to 8 weeks post-intervention ]
    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

  3. Change in scores on the CSBS Behavior Sample [ Time Frame: Change from Baseline to 8 weeks post-baseline, and from Baseline to 8 weeks post-intervention ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03404505


Contacts
Contact: Rebecca Landa, PhD, CCC-SLP 443-923-7551 landa@kennedykrieger.org

Locations
United States, Maryland
Kennedy Krieger Institute Recruiting
Baltimore, Maryland, United States, 21211
Contact: Rebecca Landa, PhD, CCC-SLP    443-923-7551    landa@kennedykrieger.org   
Principal Investigator: Rebecca Landa, PhD, CCC-SLP         
Sponsors and Collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Principal Investigator: Rebecca Landa, PhD, CCC-SLP Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Responsible Party: Rebecca Landa, Principal Investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier: NCT03404505     History of Changes
Other Study ID Numbers: IRB00065698
R21DC015846 ( U.S. NIH Grant/Contract )
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:
infant
play
parents

Additional relevant MeSH terms:
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders