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| ID | Type | Description | Link |
|---|---|---|---|
| UAB | Other Identifier | UAB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Routine EDI care including Bookworm training | Active Comparator | All study participants will receive Bookworm reading intervention training and routine EDI care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Finger puppet | Behavioral | The intervention group will receive finger-puppets and additional training pertaining to infant parent interaction and developmentally appropriate infant communication training. |
| Measure | Description | Time Frame |
|---|---|---|
| ASQ-3 scores | Ages and Stages Questionnaires 3rd Edition | 12 months corrected age |
| Measure | Description | Time Frame |
|---|---|---|
| ASQ-3 scores | Ages and Stages Questionnaires 3rd Edition | 24 months corrected age |
| ASQ scores below -2SD | Ages and Stages Questionnaires 3rd Edition |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tamaryn H Garcia | Contact | 2059344680 | thgarcia@uabmc.edu | |
| Kimberly M Armstead | Contact | 2059340095 | karmstead@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Colm P Travers | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35249 | United States |
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| ID | Term |
|---|---|
| D007235 | Infant, Premature, Diseases |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Bookworm reading intervention training and routine EDI care. | Behavioral | Routine EDI care including Bookworm training. |
|
| 12 months corrected age |
| ASQ scores below -2SD | Ages and Stages Questionnaires 3rd Edition | 24 months corrected age |
| ASQ scores below -1SD | Ages and Stages Questionnaires 3rd Edition | 12 months corrected age |
| ASQ scores below -1SD | Ages and Stages Questionnaires 3rd Edition | 24 months corrected age |
| ASQ-SE2 scores | Ages and Stages Questionnaires 3rd Edition | 12 months corrected age |
| ASQ-SE2 scores | Ages and Stages Questionnaires 3rd Edition | 24 months corrected age |
| Severe neurodevelopmental impairment | Composite outcome based on BSID scores, GMFCS, Vision, Hearing | 24 months corrected age |
| Moderate or severe neurodevelopmental impairment | Composite outcome based on BSID-IV scores, GMFCS, Vision, Hearing | 24 months corrected age |
| Cognitive Composite Score on BSID-IV | Bayley's Scales of Infant Development IV cognitive composite score | 24 months corrected age |
| Language Composite Score on BSID-IV | Bayley's Scales of Infant Development IV language composite score | 24 months corrected age |
| Motor Composite Score on BSID-IV | Bayley's Scales of Infant Development IV motor composite score | 24 months corrected age |
| Edinburgh Postnatal Depression Scale | Maternal scores on Edinburgh Postnatal Depression Scale | 6 months |
| MCHAT score | Modified Checklist for Autism in Toddlers | 24 months corrected age |