Child DevelopmentIMPACTNCT06335524
Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants
A study testing Finger puppet and Bookworm reading intervention training and routine EDI care. in people with Child Development and Infant Development, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study will test the hypothesis that in preterm infants a caregiver-implemented early developmental intervention (EDI) using finger puppets to develop joint attention and encourage interactive communication with routine EDI care including Bookworm training compared with routine EDI care including Bookworm training… Read more about this study
- Who is it for?
- Ages 1 week to 17 weeks
- Conditions the study is for
- Child Development, Infant Development, Infant, Premature, Diseases
- What is being tested?
- Finger puppet and Bookworm reading intervention training and routine EDI care.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 week to 17 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- inborn at UAB, delivered at less than 34 weeks' gestation, 32-39 weeks' PMA, off sedatives, and off invasive respiratory support.
Who cannot join
- a major malformation, a known syndrome, enrolled in a competing trial targeting neurodevelopmental outcomes as a primary outcome.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35249
Colm P Travers, MD, 2059344680, cptravers@uabmc.edu
Jillian Hamilton, PhD, 2059344680, jchamilton@uabmc.edu
About this study
Official title: Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants: A Randomized Clinical Trial
This study will test the hypothesis that in preterm infants a caregiver-implemented early developmental intervention (EDI) using finger puppets to develop joint attention and encourage interactive communication with routine EDI care including Bookworm training compared with routine EDI care including Bookworm training alone will increase the Ages and Stages Questionnaire® score at 12 months corrected age.
- Being tested
- Finger puppet, Bookworm reading intervention training and routine EDI care.
- Medical subject headings
- Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finger puppetBehavioural
The intervention group will receive finger-puppets and additional training pertaining to infant parent interaction and developmentally appropriate infant communication training.
Bookworm reading intervention training and routine EDI care.Behavioural
Routine EDI care including Bookworm training.
| Study group | Role | What they receive |
|---|---|---|
| Caregiver-implemented early developmental intervention (EDI) using finger puppets | Experimental | Caregivers of infants in the intervention group will receive finger-puppets and additional training pertaining to infant parent interaction and developmentally appropriate infant communication training. Receives: Behavioral: Finger puppet; Behavioral: Bookworm reading intervention training and routine EDI care. |
| Routine EDI care including Bookworm training | Active comparator | All study participants will receive Bookworm reading intervention training and routine EDI care. Receives: Behavioral: Bookworm reading intervention training and routine EDI care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASQ-3 scores
Ages and Stages Questionnaires 3rd Edition
Measured: 12 months corrected age
Secondary outcomes (14)
ASQ-3 scores
Ages and Stages Questionnaires 3rd Edition
Measured: 24 months corrected age
ASQ scores below -2SD
Ages and Stages Questionnaires 3rd Edition
Measured: 12 months corrected age
ASQ scores below -2SD
Ages and Stages Questionnaires 3rd Edition
Measured: 24 months corrected age
ASQ scores below -1SD
Ages and Stages Questionnaires 3rd Edition
Measured: 12 months corrected age
ASQ scores below -1SD
Ages and Stages Questionnaires 3rd Edition
Measured: 24 months corrected age
ASQ-SE2 scores
Ages and Stages Questionnaires 3rd Edition
Measured: 12 months corrected age
ASQ-SE2 scores
Ages and Stages Questionnaires 3rd Edition
Measured: 24 months corrected age
Severe neurodevelopmental impairment
Composite outcome based on BSID scores, GMFCS, Vision, Hearing
Measured: 24 months corrected age
Moderate or severe neurodevelopmental impairment
Composite outcome based on BSID-IV scores, GMFCS, Vision, Hearing
Measured: 24 months corrected age
Cognitive Composite Score on BSID-IV
Bayley's Scales of Infant Development IV cognitive composite score
Measured: 24 months corrected age
Language Composite Score on BSID-IV
Bayley's Scales of Infant Development IV language composite score
Measured: 24 months corrected age
Motor Composite Score on BSID-IV
Bayley's Scales of Infant Development IV motor composite score
Measured: 24 months corrected age
Edinburgh Postnatal Depression Scale
Maternal scores on Edinburgh Postnatal Depression Scale
Measured: 6 months
MCHAT score
Modified Checklist for Autism in Toddlers
Measured: 24 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start1 Nov 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colm Travers, University of Alabama at Birmingham
- Investigators
- Colm P Travers, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335524
- Sponsor's protocol ID
- IRB-300012718
- Other IDs
- UAB
- Acronym
- IMPACT
- Status last verified
- Dec 2025
- First submitted
- 21 Mar 2024
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06335524
- Acronym / sponsor ID
- IMPACT / IRB-300012718
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Mar 2024 (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 will test the hypothesis that in preterm infants a caregiver-implemented early developmental intervention (EDI) using finger puppets to develop joint attention and encourage interactive communication with routine EDI care including Bookworm training compared with routine EDI care including Bookworm training alone will increase the Ages and Stages Questionnaire® score at 12 months corrected age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caregiver-implemented early developmental intervention (EDI) using finger puppets | Experimental | Behavioral: Finger puppet, Behavioral: Bookworm reading intervention training and routine EDI care.Caregivers of infants in the intervention group will receive finger-puppets and additional training pertaining to infant parent interaction and developmentally appropriate infant communication training. |
| Routine EDI care including Bookworm training | Active comparator | Behavioral: Bookworm reading intervention training and routine EDI care.All study participants will receive Bookworm reading intervention training and routine EDI care. |
Who may qualify
- Ages
- 1 week to 17 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- inborn at UAB, delivered at less than 34 weeks' gestation, 32-39 weeks' PMA, off sedatives, and off invasive respiratory support.
Key exclusion criteria (1 listed)
- a major malformation, a known syndrome, enrolled in a competing trial targeting neurodevelopmental outcomes as a primary outcome.
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 |
|---|---|---|
| Finger puppetThe intervention group will receive finger-puppets and additional training pertaining to infant parent interaction and developmentally appropriate infant communication training. | Behavioural | Caregiver-implemented early developmental intervention (EDI) using finger puppets |
| Bookworm reading intervention training and routine EDI care.Routine EDI care including Bookworm training. | Behavioural | Caregiver-implemented early developmental intervention (EDI) using finger puppets, Routine EDI care including Bookworm training |
Primary outcome
ASQ-3 scores
Time frame: 12 months corrected age
Ages and Stages Questionnaires 3rd Edition
14 secondary outcomes
ASQ-3 scores
Time frame: 24 months corrected age
ASQ scores below -2SD
Time frame: 12 months corrected age
ASQ scores below -2SD
Time frame: 24 months corrected age
ASQ scores below -1SD
Time frame: 12 months corrected age
ASQ scores below -1SD
Time frame: 24 months corrected age
ASQ-SE2 scores
Time frame: 12 months corrected age
ASQ-SE2 scores
Time frame: 24 months corrected age
Severe neurodevelopmental impairment
Time frame: 24 months corrected age
Moderate or severe neurodevelopmental impairment
Time frame: 24 months corrected age
Cognitive Composite Score on BSID-IV
Time frame: 24 months corrected age
Language Composite Score on BSID-IV
Time frame: 24 months corrected age
Motor Composite Score on BSID-IV
Time frame: 24 months corrected age
Edinburgh Postnatal Depression Scale
Time frame: 6 months
MCHAT score
Time frame: 24 months corrected age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Colm P Travers principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Finger puppet and Bookworm reading intervention training and routine EDI care. in people with Child Development and Infant Development, run by University of Alabama at Birmingham 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 29 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tamaryn H Garcia (2059344680, thgarcia@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASQ-3 scores (time frame: 12 months corrected age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2025.