Younger Sibling of Child With Autism Spectrum DisorderIANCT03404505
Effects of a Short-term Parent Mediated Social Training on Developmental Trajectories in Infants
A study testing Infant Achievements and Caregiver Education (CE) in people with Younger Sibling of Child With Autism Spectrum Disorder and Signs of Developmental Delay, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Younger Sibling of Child With Autism Spectrum Disorder, Signs of Developmental Delay, Signs of Communication Delay
- What is being tested?
- Infant Achievements and Caregiver Education (CE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2017to 15 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kennedy Krieger Institute
Baltimore, Maryland, 21211
About this study
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.
Read the 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.
- Conditions
- Younger Sibling of Child With Autism Spectrum Disorder, Signs of Developmental Delay, Signs of Communication Delay, Signs of Social Delay
- Being tested
- Infant Achievements, Caregiver Education (CE)
- Keywords
- infant, play, parents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant AchievementsBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Infant Achievements | Experimental | 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. Receives: Behavioral: Infant Achievements |
| Caregiver Education | Experimental | 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. Receives: Behavioral: Caregiver Education (CE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from behavior at Baseline to behavior at 8 weeks post-baseline, and from Baseline to 8 weeks post-intervention
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
Measured: Change from behavior at Baseline to behavior at 8 weeks post-baseline, and from Baseline to 8 weeks post-intervention
Secondary outcomes (3)
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
Measured: Change from Baseline to 8 weeks post-baseline and from Baseline to 8 weeks post-intervention
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
Measured: Change from Baseline to 8 weeks post-baseline and from Baseline to 8 weeks post-intervention
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
Measured: Change from Baseline to 8 weeks post-baseline and from Baseline to 8 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start3 Nov 2017
- Primary completion15 Dec 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Younger Sibling of Child With Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Investigators
- Rebecca Landa, PhD, CCC-SLP, Principal investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404505
- Sponsor's protocol ID
- IRB00065698
- Other IDs
- R21DC015846
- Acronym
- IA
- Status last verified
- Sep 2025
- First submitted
- 19 Oct 2017
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Landa RJ, Reetzke R, Hess CR. Infant Achievements Intervention Improves Caregiver Implementation Fidelity and Infant Social Communication Outcomes: A Preliminary Randomized Clinical Trial. Autism Res. 2025 May;18(5):1104-1116. doi: 10.1002/aur.70051. Epub 2025 May 2.
PubMed 40318004
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Short-term Parent Mediated Social Training on Developmental Trajectories in Infants
- ClinicalTrials.gov ID
- NCT03404505
- Acronym / sponsor ID
- IA / IRB00065698
- Conditions
- Younger Sibling of Child With Autism Spectrum Disorder, Signs of Developmental Delay, Signs of Communication Delay, Signs of Social Delay
- Keywords
- infant, play, parents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infant Achievements | Experimental | Behavioral: Infant AchievementsFamilies 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. |
| Caregiver Education | Experimental | Behavioral: Caregiver Education (CE)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 may qualify
- Ages
- 8 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant AchievementsPlay-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. | Behavioural | Infant Achievements |
| 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. | Behavioural | Caregiver Education |
Primary outcome
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
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Derived from this study: PubMed 40318004Landa RJ, Reetzke R, Hess CR. Infant Achievements Intervention Improves Caregiver Implementation Fidelity and Infant Social Communication Outcomes: A Preliminary Randomized Clinical Trial. Autism Res. 2025 May;18(5):1104-1116. doi: 10.1002/aur.70051. Epub 2025 May 2.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Landa, PhD, CCC-SLP principal investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Achievements and Caregiver Education (CE) in people with Younger Sibling of Child With Autism Spectrum Disorder and Signs of Developmental Delay, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03404505, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.