Measuring and Reducing Excessive Infant Crying (UTHealth THB)
Measuring and Reducing Excessive Infant Crying: A Randomized Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Hypotheses: The soothing techniques taught to study parents 2-3 wks after birth augment parental soothing skills and reduces infant crying at night (primary outcome) and parental sleep loss, distress, & depression assessed in the home by a masked nurse at 8 wks.
Methods: Term singleton infants with EIC (> 3 hrs/24h) recruited through a program offered to parents at our hospital (4,700 births/yr) will be seen in our clinic 2-3 wks after birth. Consenting families (n=178) will be randomized to standard colic counseling (American Academy of Pediatrics) or to the intervention (adding nurse instruction plus a video and pamphlets). At 8 wks a study nurse will assess parental sleep and distress (Brief Symptom Inventory-18), place dosimeters in rooms where the infant sleeps and spends most time, and apply the actigraph at the ankle. She will collect the devices 5 days later, perform a physical exam at a usual feeding time (when EIC is likely), record infant & maternal behaviors during crying/feeding for the next 15 minutes using unobtrusive, validated methods (Tyson, 1992), and provide maternal support if desired. Standard statistical tests will be used (alpha=0.05; beta = 0.20; effect size =0.5 SD, power = .90).
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Texas
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Houston, Texas, États-Unis, 77030
- University of Texas Health Science Center at Houston
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- term, singleton neonates
- otherwise healthy
- parent must have at least a 6th grade understanding of English or Spanish
- infant must have colic (greater than 3 hours of crying per day)
- OR the infant's crying causes excessive stress on the either parent
Exclusion Criteria:
- cannot have a condition which would reasonably impact alertness or behavior
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: The Happiest Baby on The Block
Those receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block".
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Those receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block".
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Comparateur actif: AAP Education
Those receiving the control group allocation will be counseled in the American Academy of Pediatrics guidelines regarding Infant Colic (AAP Infant Colic counseling).
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Those receiving the control group allocation will be counseled using the American Academy of Pediatrics material for Infant Colic.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mean night-time crying
Délai: 2 weeks after enrollment. Appproximately 6-8 weeks of life.
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Objectively recording night-time duration of excessive crying
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2 weeks after enrollment. Appproximately 6-8 weeks of life.
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Mean sleep duration
Délai: 2 weeks after enrollment. Appproximately 6-8 weeks of life.
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objectively measuring infant sleep duration
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2 weeks after enrollment. Appproximately 6-8 weeks of life.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Maternal Depression, Anxiety and Somatization
Délai: At study entry and conculsion (4 week interval); 2 weeks after enrollment. Appproximately 6-8 weeks of life.
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Using the BSI-18 at study enrollment and conclusion.
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At study entry and conculsion (4 week interval); 2 weeks after enrollment. Appproximately 6-8 weeks of life.
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Salivary Biomarkers
Délai: At Study Entry and at 2 weeks after enrollment
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We are collecting maternal salivary cortisol and amylase at study entry and at study conclusion (within 2 weeks after enrollment)
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At Study Entry and at 2 weeks after enrollment
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Collaborateurs et enquêteurs
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HSC-MS-10-0392
- K23HD065872 (Subvention/contrat des NIH des États-Unis)
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