Abusive Head TraumaEarlyABCsNCT02055573
The Early ABCs Study
A study testing Ready To Learn (RTL) and All Babies Cry (ABC) in people with Abusive Head Trauma and Early Literacy, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abusive Head Trauma, Early Literacy
- What is being tested?
- Ready To Learn (RTL) and All Babies Cry (ABC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Jan 2015
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mothers of healthy Singleton, full term infants
- Born at Women \& Infants Hospital
Who cannot join
- 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.
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Women & Infants' Hospital
Providence, Rhode Island, 02903
About this study
Official title: Can we Promote Early Literacy and Prevent Shaken Baby Syndrome in the Well Child Nursery?.A Randomized Controlled Study, The Early ABC Study.
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.
Read more
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.
Read the detailed description
Quality assurance Plan: The PI and collaborators will be overseen collection and processing of data.
Standard Operating Procedures:
Recruitment: A bilingual Research Assistant will review mother's records at Women \& Infants' Hospital mother-baby unit to identify eligible mothers.
Dyads will be excluded if the mother:
- Is not insured by Medicaid, Ritecare, or Neighborhood Health Plan.
- Is not fluent in either English or Spanish.
- Is 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.
- Does not have access to DVD player
- Refuses to participate in the study.
Dyads will be excluded if the infant:
- Is born premature (<37 wks G.A)
- Is born at low birth weight (<5 pounds or 2500 grams at birth)
- 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
Data Collection/Management and Analysis:
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 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 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. We will enroll 75 mothers who speak Spanish primarily at home in each intervention group, as well as 75 mothers who speak primarily English in each arm. 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 blinded to the intervention status at 2-5 months post-partum containing similar questions. Data will be entered into Excel and transferred into STATA for analysis.
Sample Size calculation:
For power analysis, we used categorical (behavioral) outcomes to arrive at conservative estimates of sample sizes with a 0.05 significance level. Effect sizes for differences in proportions are based on Cohen's h statistic (Cohen, 1988), computed for 80% power and Two-tailed significance test at alpha = 0.05 with equal numbers of participants in the intervention and control groups and a Confidence Interval of 95%.
From a previous study of the All Babies Cry intervention at 5 weeks postpartum 36% of control group answered similar knowledge questions correctly, compared to 47% of those receiving the All Babies Cry Intervention. This resulted in a difference of 11% and SD of 18 in the control group and 19 in the intervention group.
Based on this using Open Epi for sample size calculation we arrived at a group size of 45 subjects in each branch of the study. Althouhg in the original All Babies Cry Intervention we had a follow up rate of 77% at 17 weeks, our current estimates are closer to 40-45%. To account for a possible loss to follow up of 60% of subjects we will increase the sample size from 45 to 75 individuals in each group for a total of 150 subjects in each branch of the study.
Previous studies of Early Literacy interventions in low income families have shown larger differences in similar literacy outcomes to ours. We are therefore basing our calculations on a more conservative data assumption.
Statistical 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 baseline and at both follow up interviews.
- Conditions
- Abusive Head Trauma, Early Literacy
- Being tested
- Ready To Learn (RTL), All Babies Cry (ABC)
- Keywords
- Abusive Head Trauma, Early Literacy, Parental Education, Low Income
- Medical subject headings
- Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ready To Learn (RTL)Other
See arm description
All Babies Cry (ABC)Other
See arm description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: All Babies Cry (ABC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2-5 months
Secondary outcomes (8)
Reading together is one of the baby's 3 favorite activities.
At follow-up, mothers are asked what their baby's 3 favorite things to do are. We hypothesize that more mothers in the RTL Arm will spontaneously mention reading books with their parents as one of the baby's 3 favorite activities, compared to ABC arm mothers.
Measured: 2-5 months
Number of children's books in the home
At follow-up mothers are asked how many children's books are in their home. We hypothesize that mothers in the RTL arm will report having more children's books in their homes compared to the numbers of children's books in the homes of ABC arm mothers.
Measured: 2-5 months
Reading with their baby is identified as a way of preparing him/her for school
Mothers are asked if there is anything they plan to do with their child to help the child do well when he/she goes to school. We hypothesize that more RTL mothers compared to ABC mothers will spontaneously mention reading together or books as a way of promoting their child's readiness for school.
Measured: 2-5 months
Talking, singing and/or playing with their babies is identified as a favorite shared activity
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 talking, singing and/or playing together as a favorite shared activity compared to ABC Arm mothers.
Measured: 2-5 months
Number of calming strategies for parenting stress identified
At follow-up mothers are asked to identify ways of calming themselves if their baby is crying inconsolably. We hypothesize that mothers in the ABC arm will identify more strategies for calming themselves if their baby is crying, compared to RTL arm mothers.
Measured: 2-5 months
Number of soothing strategies to calm fussy babies identified
At follow-up mothers are asked to identify ways of soothing their babies if they are crying inconsolably. We hypothesize that mothers in the ABC arm will identify more strategies for soothing their babies if they are crying inconsolably, compared to RTL arm mothers.
Measured: 2-5 months
Knowledge that responding to babies younger than 6 months of age whenever they cry won't spoil them
At follow-up interview mothers are asked if they believe that by responding to a baby in the first 6 months of life every time he/she starts to cry he/she can get spoiled. We hypothesize that more mothers in the ABC Arm of the study will know that they can't spoil a baby less than 6 months old by responding to all their cries, as compared to RTL arm mothers.
Measured: 2-5 months
Knowledge that shaking a baby can cause brain damage or death
At follow-up interview mothers are asked if they have heard what could happen if a baby is shaken. We hypothesize that more mothers in the ABC Arm of the study will correctly identify that babies can sustain brain damage or die if they are shaken compared to RTL Arm mothers
Measured: 2-5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Abusive Head TraumaStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- Lifespan
- Responsible party
- Sponsor
- Investigators
- Marcia W VanVleet, MD, MPH, Principal investigator, Women & Infants' Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055573
- Sponsor's protocol ID
- WIH 13-0080
- Acronym
- EarlyABCs
- Status last verified
- Jun 2015
- First submitted
- 10 Jan 2014
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22201148Barr 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.
PubMed 19255065Duursma 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.
PubMed 18477693Keeton 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.
PubMed 18410208Lewin 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.
PubMed 18557853Lee 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.
PubMed 17700080Berkule 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.
PubMed 17261482Evanoo 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.
PubMed 17825733Tomopoulos 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.
PubMed 16530142High 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.
PubMed 10742349Golova 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.
PubMed 10224178Barr 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.
PubMed 2332126Mendelsohn 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.
PubMed 11134446Needlman 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.
PubMed 16026185
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can we Promote Early Literacy and Prevent Shaken Baby Syndrome in the Well Child Nursery?.A Randomized Controlled Study, The Early ABC Study.
- ClinicalTrials.gov ID
- NCT02055573
- Acronym / sponsor ID
- EarlyABCs / WIH 13-0080
- Conditions
- Abusive Head Trauma, Early Literacy
- Keywords
- Abusive Head Trauma, Early Literacy, Parental Education, Low Income
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Collaborators
- Lifespan
- Study start
- Feb 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 5 Feb 2014 (estimated)
- 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.
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.
Detailed description
Quality assurance Plan: The PI and collaborators will be overseen collection and processing of data.
Standard Operating Procedures:
Recruitment: A bilingual Research Assistant will review mother's records at Women \& Infants' Hospital mother-baby unit to identify eligible mothers.
Dyads will be excluded if the mother:
- Is not insured by Medicaid, Ritecare, or Neighborhood Health Plan.
- Is not fluent in either English or Spanish.
- Is 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.
- Does not have access to DVD player
- Refuses to participate in the study.
Dyads will be excluded if the infant:
- Is born premature (<37 wks G.A)
- Is born at low birth weight (<5 pounds or 2500 grams at birth)
- 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
Data Collection/Management and Analysis:
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 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 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. We will enroll 75 mothers who speak Spanish primarily at home in each intervention group, as well as 75 mothers who speak primarily English in each arm. 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 blinded to the intervention status at 2-5 months post-partum containing similar questions. Data will be entered into Excel and transferred into STATA for analysis.
Sample Size calculation:
For power analysis, we used categorical (behavioral) outcomes to arrive at conservative estimates of sample sizes with a 0.05 significance level. Effect sizes for differences in proportions are based on Cohen's h statistic (Cohen, 1988), computed for 80% power and Two-tailed significance test at alpha = 0.05 with equal numbers of participants in the intervention and control groups and a Confidence Interval of 95%.
From a previous study of the All Babies Cry intervention at 5 weeks postpartum 36% of control group answered similar knowledge questions correctly, compared to 47% of those receiving the All Babies Cry Intervention. This resulted in a difference of 11% and SD of 18 in the control group and 19 in the intervention group.
Based on this using Open Epi for sample size calculation we arrived at a group size of 45 subjects in each branch of the study. Althouhg in the original All Babies Cry Intervention we had a follow up rate of 77% at 17 weeks, our current estimates are closer to 40-45%. To account for a possible loss to follow up of 60% of subjects we will increase the sample size from 45 to 75 individuals in each group for a total of 150 subjects in each branch of the study.
Previous studies of Early Literacy interventions in low income families have shown larger differences in similar literacy outcomes to ours. We are therefore basing our calculations on a more conservative data assumption.
Statistical 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 baseline and at both follow up interviews.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ready To Learn | Experimental | Other: Ready To Learn (RTL)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. |
| All Babies Cry | Experimental | Other: All Babies Cry (ABC)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mothers of healthy Singleton, full term infants
- Born at Women \& Infants Hospital
Key exclusion criteria (15 listed)
- 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.
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 |
|---|---|---|
| Ready To Learn (RTL)See arm description | Other | Ready To Learn |
| All Babies Cry (ABC)See arm description | Other | All Babies Cry |
Primary outcome
Days/week mothers report reading with their infants
Time frame: 2-5 months
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.
Reading with their baby is one of mother's favorite shared activities
Time frame: 2-5 months
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.
Knowledge of the typical peak of infant crying
Time frame: 2-5 months
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.
Having heard what can happen if a baby is shaken
Time frame: 2-5 months
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.
8 secondary outcomes
Reading together is one of the baby's 3 favorite activities.
Time frame: 2-5 months
Number of children's books in the home
Time frame: 2-5 months
Reading with their baby is identified as a way of preparing him/her for school
Time frame: 2-5 months
Talking, singing and/or playing with their babies is identified as a favorite shared activity
Time frame: 2-5 months
Number of calming strategies for parenting stress identified
Time frame: 2-5 months
Number of soothing strategies to calm fussy babies identified
Time frame: 2-5 months
Knowledge that responding to babies younger than 6 months of age whenever they cry won't spoil them
Time frame: 2-5 months
Knowledge that shaking a baby can cause brain damage or death
Time frame: 2-5 months
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 4 Jun 2015.
- Background: PubMed 22201148Garner 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.
- Background: PubMed 19255065Barr 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.
- Background: PubMed 18477693Duursma 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.
- Background: PubMed 18410208Keeton 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.
- Background: PubMed 18557853Lewin 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.
- Background: PubMed 17700080Lee 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.
- Background: PubMed 17261482Berkule 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.
- Background: PubMed 17825733Evanoo 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.
- Background: PubMed 16530142Tomopoulos 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.
- Background: PubMed 10742349High 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.
- Background: PubMed 10224178Golova 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.
- Background: PubMed 2332126Barr 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.
- 4\. National Institute for Literacy. 2008. Developing early literacy: Report of the National Early Literacy Panel.Link provided by the sponsor.
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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. This study is not recruiting at the moment.
Marcia W VanVleet, MD, MPH principal investigator
Women & Infants' Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ready To Learn (RTL) and All Babies Cry (ABC) in people with Abusive Head Trauma and Early Literacy, run by Women and Infants Hospital of Rhode Island 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 2 inclusion and 15 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 4 Jun 2015. 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?
Days/week mothers report reading with their infants (time frame: 2-5 months). The study lists 4 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 NCT02055573, which also lists 14 linked publications.
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 4 Jun 2015.