The Early ABCs Study

NCT02055573 | Completed

• 1 other identifier: WIH 13-0080
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Regular reading with young children strengthens the parent-child relationship and builds their language, literacy and social emotional skills. Parent knowledge of normal variation of infant crying and of the dangers of shaking a baby as well as their ability to cope with infant irritability are likely factors in their successful adjustment to parenthood and the prevention of this tragic act. Purpose: Identify easily implementable interventions for economically disadvantaged mothers in the newborn period which 1) Promote early literacy behaviors and early nurturing parent-child relationships and 2) Increase mother's knowledge of normal crying patterns, the dangers of shaking a baby and her ability to cope with parenting stresses. Design/Methods: A convenience sample of 300 low income (insured by Medicaid) new mothers of healthy singleton, full term infants in the level 1 mother/baby unit at Women \& Infants Hospital will be invited to participate in a Randomized Controlled Trial study of educational videos and materials for parents. They will be randomized into one of two intervention groups. 1) The Ready to Learn (RTL) arm will receive a DVD in both Spanish and English and a bilingual booklet (both produced by Parents' action for Children) addressing the benefits of reading, talking and playing with young children, as well as a new children's board book. 2) The All Babies Cry (ABC) arm will receive a DVD in both, Spanish and English and a bilingual booklet (both produced by VIDA) explaining crying as part of normal infant behavior, highlighting signs of parental distress and providing strategies to sooth parents and their children. We will enroll 75 mothers who speak Spanish primarily at home in each intervention group, as well as 75 mothers who speak primarily English. The RTL mothers will serve as controls for the ABC mothers and vice versa. Before reviewing the materials, mothers will be asked to respond to a baseline interview with socio-demographic information, questions regarding Early Literacy promotion, reading with children and their own reading habits as well as general knowledge on the prevention of shaking a baby and handling their own stress. Follow up phone interviews will be conducted by a bilingual research assistant blind to the intervention status at 2-5 months post-partum containing similar questions. Consenting mothers will receive a bag of diapers at the completion of enrollment interview as an incentive for participating in the study. Data will be entered into Excel and transferred into STATA for analysis. Frequency counts will be generated for demographic, literacy related and parental knowledge and stress variables in the two intervention arms. Chi-Square and T-tests will be used to compare literacy and parental knowledge outcomes for each intervention group at both follow up interviews. Hypotheses: 1) Mothers in the RTL branch will recognize the importance of reading to their babies, initiating this activity at earlier ages and reading more often with them. 2) Mothers in the ABC branch will gain an understanding of crying as part of normal infant behavior and build strategies to sooth themselves and their newborns.

Conditions

Abusive Head Trauma; Early Literacy

Keywords

Abusive Head Trauma; Early Literacy; Parental Education; Low Income

Outcome Measures

Primary Outcomes (4)

• Days/week mothers report reading with their infants

  Mothers are asked how many days/week they read with their babies at 2-5 months. We hypothesize that mothers in the RTL Arm will report that they read with their babies more days/week compared to ABC Arm mothers.

  2-5 months

• Reading with their baby is one of mother's favorite shared activities

  Mothers are asked what their 3 favorite things to do with their babies are. We hypothesize that more mothers in the RTL Arm will spontaneously mention reading books together.

  2-5 months

• Knowledge of the typical peak of infant crying

  At follow-up interview mothers are asked if they know at what age infants tend to cry the most and they are given 7 options. We hypothesize that more mothers in the ABC Arm of the study will correctly identify 6-8 weeks as the peak of infant crying compared to RTL Arm mothers.

  2-5 months

• Having heard what can happen if a baby is shaken

  At follow-up mothers are asked if they have heard or read what could happen if a baby is shaken. We hypothesize that more mothers in the ABC arm of the study will report having heard of what could happen if a baby is shaken.

  2-5 months

Secondary Outcomes (8)

• Reading together is one of the baby's 3 favorite activities.

  2-5 months

• Number of children's books in the home

  2-5 months

• Reading with their baby is identified as a way of preparing him/her for school

  2-5 months

• Talking, singing and/or playing with their babies is identified as a favorite shared activity

  2-5 months

• Number of calming strategies for parenting stress identified

  2-5 months

Other Outcomes (3)

• Other caregivers are reading with baby

  2-5 months

• DVD/Booklet promotes reading, playing or talking with baby

  2-5 months

• DVD/Booklet teaches how to calm baby or self

  2-5 months

Study Arms (2)

Ready To Learn

EXPERIMENTAL

1\) The Ready to Learn (RTL) arm will receive a DVD in both Spanish and English and a bilingual booklet (both produced by Parents' action for Children) addressing the benefits of reading, talking and playing with young children, as well as a new children's board book.

Other: Ready To Learn (RTL)

All Babies Cry

EXPERIMENTAL

2\) The All Babies Cry (ABC) arm will receive a DVD in both, Spanish and English and a bilingual booklet (both produced by VIDA Health Communications, INC) explaining crying as part of normal infant behavior, highlighting signs of parental distress and providing strategies to sooth parents and their children

Other: All Babies Cry (ABC)

Interventions

Ready To Learn (RTL) OTHER

See arm description

Ready To Learn

All Babies Cry (ABC) OTHER

See arm description

All Babies Cry

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mothers of healthy Singleton, full term infants
• Born at Women \& Infants Hospital

You may not qualify if:

• Mothers will be excluded if they:
• Are not insured by Medicaid, Ritecare, or Neighborhood Health Plan.
• Are not fluent in either English or Spanish.
• Are younger than 18 years of age.
• Will not be taking the baby home at hospital discharge.
• Will be leaving USA within the following 6 months for longer than two weeks.
• Is discharged from the hospital prior to being approached or scheduling interview.
• Do not have access to DVD player
• Refuse to participate in the study.
• Mothers will be excluded if the infant:
• Is born premature (\<37 wks G.A)
• Is born at low birth weight (\<5 pounds at birth or 2500 grams)
• Spent \>24 hours in the Neonatal Intensive Care Unit
• Was born with a significant anomaly or genetic syndrome associated with delay
• Has a P.R.E with a hold with DCYF

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead
• Lifespan: collaborator

Study Sites (1)

Women & Infants' Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (14)

• Garner AS, Shonkoff JP; Committee on Psychosocial Aspects of Child and Family Health; Committee on Early Childhood, Adoption, and Dependent Care; Section on Developmental and Behavioral Pediatrics. Early childhood adversity, toxic stress, and the role of the pediatrician: translating developmental science into lifelong health. Pediatrics. 2012 Jan;129(1):e224-31. doi: 10.1542/peds.2011-2662. Epub 2011 Dec 26.

  PMID: 22201148 BACKGROUND

• Barr RG, Barr M, Fujiwara T, Conway J, Catherine N, Brant R. Do educational materials change knowledge and behaviour about crying and shaken baby syndrome? A randomized controlled trial. CMAJ. 2009 Mar 31;180(7):727-33. doi: 10.1503/cmaj.081419. Epub 2009 Mar 2.

  PMID: 19255065 BACKGROUND

• Duursma E, Augustyn M, Zuckerman B. Reading aloud to children: the evidence. Arch Dis Child. 2008 Jul;93(7):554-7. doi: 10.1136/adc.2006.106336. Epub 2008 May 13. No abstract available.

  PMID: 18477693 BACKGROUND

• Keeton CP, Perry-Jenkins M, Sayer AG. Sense of control predicts depressive and anxious symptoms across the transition to parenthood. J Fam Psychol. 2008 Apr;22(2):212-21. doi: 10.1037/0893-3200.22.2.212.

  PMID: 18410208 BACKGROUND

• Lewin L. Shaken baby syndrome: facts, education, and advocacy. Nurs Womens Health. 2008 Jun;12(3):235-9. doi: 10.1111/j.1751-486X.2008.00328.x. No abstract available.

  PMID: 18557853 BACKGROUND

• Lee C, Barr RG, Catherine N, Wicks A. Age-related incidence of publicly reported shaken baby syndrome cases: is crying a trigger for shaking? J Dev Behav Pediatr. 2007 Aug;28(4):288-93. doi: 10.1097/DBP.0b013e3180327b55.

  PMID: 17700080 BACKGROUND

• Berkule SB, Dreyer BP, Huberman HS, Fierman AH, Mendelsohn AL. Attitudes about shared reading among at-risk mothers of newborn babies. Ambul Pediatr. 2007 Jan-Feb;7(1):45-50. doi: 10.1016/j.ambp.2006.10.004.

  PMID: 17261482 BACKGROUND

• Evanoo G. Infant crying: a clinical conundrum. J Pediatr Health Care. 2007 Sep-Oct;21(5):333-8. doi: 10.1016/j.pedhc.2007.06.014. No abstract available.

  PMID: 17825733 BACKGROUND

• Tomopoulos S, Dreyer BP, Tamis-LeMonda C, Flynn V, Rovira I, Tineo W, Mendelsohn AL. Books, toys, parent-child interaction, and development in young Latino children. Ambul Pediatr. 2006 Mar-Apr;6(2):72-8. doi: 10.1016/j.ambp.2005.10.001.

  PMID: 16530142 BACKGROUND

• High PC, LaGasse L, Becker S, Ahlgren I, Gardner A. Literacy promotion in primary care pediatrics: can we make a difference? Pediatrics. 2000 Apr;105(4 Pt 2):927-34.

  PMID: 10742349 BACKGROUND

• Golova N, Alario AJ, Vivier PM, Rodriguez M, High PC. Literacy promotion for Hispanic families in a primary care setting: a randomized, controlled trial. Pediatrics. 1999 May;103(5 Pt 1):993-7. doi: 10.1542/peds.103.5.993.

  PMID: 10224178 BACKGROUND

• Barr RG. The normal crying curve: what do we really know? Dev Med Child Neurol. 1990 Apr;32(4):356-62. doi: 10.1111/j.1469-8749.1990.tb16949.x. No abstract available.

  PMID: 2332126 BACKGROUND

• Mendelsohn AL, Mogilner LN, Dreyer BP, Forman JA, Weinstein SC, Broderick M, Cheng KJ, Magloire T, Moore T, Napier C. The impact of a clinic-based literacy intervention on language development in inner-city preschool children. Pediatrics. 2001 Jan;107(1):130-4. doi: 10.1542/peds.107.1.130.

  PMID: 11134446 BACKGROUND

• Needlman R, Toker KH, Dreyer BP, Klass P, Mendelsohn AL. Effectiveness of a primary care intervention to support reading aloud: a multicenter evaluation. Ambul Pediatr. 2005 Jul-Aug;5(4):209-15. doi: 10.1367/A04-110R.1.

  PMID: 16026185 BACKGROUND

Related Links

• 4\. National Institute for Literacy. 2008. Developing early literacy: Report of the National Early Literacy Panel.

MeSH Terms

Conditions

Literacy

Condition Hierarchy (Ancestors)

Communication; Behavior

Study Officials

• Marcia W VanVleet, MD, MPH

  Women & Infants' Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: February 5, 2014
• Study Start: February 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: June 4, 2015

Record last verified: 2015-06

Locations

US (1)