Premature BirthNCT00056680
Three-Part Program for Parents With Premature Infants
A study testing Psychoeducational video, Infant massage and Brazelton Neonatal Behavioral Assessment Scale in people with Premature Birth, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 5 sites in United States.
Trial summary
This study evaluated the efficacy of a comprehensive, three-part program for parents of premature infants. This program was designed to improve development in preterm children and includes an educational video, tests to evaluate the child's strengths and abilities, and instruction in infant massage. Read more about this study
- Who is it for?
- Ages 32 to 37 weeks
- Conditions the study is for
- Premature Birth
- What is being tested?
- Psychoeducational video, Infant massage and Brazelton Neonatal Behavioral Assessment Scale
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 173 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2001to Dec 2006
- 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 32 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born < 37 weeks gestational age
- Mothers 18 years of age or older
- African American
Who cannot join
- Infants with chromosomal abnormalities or other genetic syndromes
- Mothers with positive postpartum toxicology screens
- Infants destined for foster care
- Note: age limits for infants refer to post-conceptual age (not actual age)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
Mercy Medical Center
Baltimore, Maryland, 21202
The Pennsylvania State University
University Park, Pennsylvania, 16802
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Adult Attachment and Intervention Efficacy With Preterms
This study evaluated the efficacy of a comprehensive, three-part program for parents of premature infants. This program was designed to improve development in preterm children and includes an educational video, tests to evaluate the child's strengths and abilities, and instruction in infant massage.
Read the detailed description
Premature birth is a major cause of developmental delay, and cost-effective, replicable methods to promote development in preterm children are needed. Despite the success of first generation interventions, little is understood about why early intervention does not affect all parents and preterms to the same degree.
This study assessed the efficacy of a three-component intervention (psychoeducational video, serial administrations of the Brazelton Neonatal Behavioral Assessment Scale, and parent-administered infant massage) that targets preterm infants and their mothers and fathers. Outcome measures included infant physical, intellectual, and socioemotional development; parental sensitivity; and infant-parent attachment. The project also assessed the role of parental state of mind regarding attachment and parental commitment to the intervention.
Participants in this study were urban African American mothers and fathers of preterm, low birthweight infants admitted to the neonatal intensive care unit. Fathers were eligible for the study if nominated by the child's mother. Participants were randomly assigned to an intervention group or a control group. Both groups were comparable with respect to race, maternal pregnancy history, education, income, presence/absence of partner, infant gestational age, infant small-for-date status, and infant gender.
The intervention group viewed a videotape about preterm infant abilities. Over the course of the study, the intervention group administered infant massage and completed multiple administrations of the Brazelton Neonatal Behavioral Assessment Scale with increasing parental involvement.
The intervention began when infants were 32 to 36 weeks post-conceptual age (PCA) and ended when infants are 52 to 56 weeks PCA. The efficacy of the intervention and the moderating roles of adult attachment and parental commitment to the intervention were evaluated in terms of infant physical, mental, motor, and social development, and parental adjustment and sensitivity to the infant during the first 2 years.
- Conditions
- Premature Birth
- Being tested
- Psychoeducational video, Infant massage, Brazelton Neonatal Behavioral Assessment Scale
- Keywords
- Prematurity, low birthweight, parenting, intervention
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational videoBehavioural
Infant massageBehavioural
Brazelton Neonatal Behavioral Assessment ScaleBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometrics (weight, height, head circumference), Bayley Scales of Infant Development, infant behavioral problems and behavioral competencies, maternal sensitivity, infant-parent attachment
Measured: collected at 4, 12, and 24 months of infant age
Secondary outcomes (1)
Maternal self-efficacy, parenting stress, perceptions of infant temperament
Measured: Collected at 4, 12, and 24 months of infant age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2003 (estimated)
- Study startJul 2001
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Douglas M. Teti, Ph.D., Principal investigator, The Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00056680
- Sponsor's protocol ID
- 1R01HD38982-1A6
- Other IDs
- 1R01HD038982
- Status last verified
- May 2007
- First submitted
- 20 Mar 2003
- Last updated
- 20 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Teti DM, Hess CR, O'Connell M. Parental perceptions of infant vulnerability in a preterm sample: prediction from maternal adaptation to parenthood during the neonatal period. J Dev Behav Pediatr. 2005 Aug;26(4):283-92. doi: 10.1097/00004703-200508000-00004.
PubMed 16100501Teti, D. M., & Killeen, L. (in press). The role of parental states of mind in effecting parental commitment to an intervention program for premature infants and their parents. In H. Steele & M. Steele (Eds.), The Adult Attachment Interview in Clinical Context. New York: Guilford Press.
Candelaria, MA, O'Connell, MA, & Teti, DM. (2006). Cumulative psychosocial and medical risk as predictors of early infant development and parenting stress in an African-American preterm sample. Journal of Applied Developmental Psychology, 27(6), 588-597.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adult Attachment and Intervention Efficacy With Preterms
- ClinicalTrials.gov ID
- NCT00056680
- Acronym / sponsor ID
- 1R01HD38982-1A6
- Conditions
- Premature Birth
- Keywords
- Prematurity, low birthweight, parenting, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Jul 2001
- Study completion
- Dec 2006 (actual)
- First posted
- 24 Mar 2003 (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.
This study evaluated the efficacy of a comprehensive, three-part program for parents of premature infants. This program was designed to improve development in preterm children and includes an educational video, tests to evaluate the child's strengths and abilities, and instruction in infant massage.
Detailed description
Premature birth is a major cause of developmental delay, and cost-effective, replicable methods to promote development in preterm children are needed. Despite the success of first generation interventions, little is understood about why early intervention does not affect all parents and preterms to the same degree.
This study assessed the efficacy of a three-component intervention (psychoeducational video, serial administrations of the Brazelton Neonatal Behavioral Assessment Scale, and parent-administered infant massage) that targets preterm infants and their mothers and fathers. Outcome measures included infant physical, intellectual, and socioemotional development; parental sensitivity; and infant-parent attachment. The project also assessed the role of parental state of mind regarding attachment and parental commitment to the intervention.
Participants in this study were urban African American mothers and fathers of preterm, low birthweight infants admitted to the neonatal intensive care unit. Fathers were eligible for the study if nominated by the child's mother. Participants were randomly assigned to an intervention group or a control group. Both groups were comparable with respect to race, maternal pregnancy history, education, income, presence/absence of partner, infant gestational age, infant small-for-date status, and infant gender.
The intervention group viewed a videotape about preterm infant abilities. Over the course of the study, the intervention group administered infant massage and completed multiple administrations of the Brazelton Neonatal Behavioral Assessment Scale with increasing parental involvement.
The intervention began when infants were 32 to 36 weeks post-conceptual age (PCA) and ended when infants are 52 to 56 weeks PCA. The efficacy of the intervention and the moderating roles of adult attachment and parental commitment to the intervention were evaluated in terms of infant physical, mental, motor, and social development, and parental adjustment and sensitivity to the infant during the first 2 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 32 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants born < 37 weeks gestational age
- Mothers 18 years of age or older
- African American
Key exclusion criteria (4 listed)
- Infants with chromosomal abnormalities or other genetic syndromes
- Mothers with positive postpartum toxicology screens
- Infants destined for foster care
- Note: age limits for infants refer to post-conceptual age (not actual age)
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 |
|---|---|---|
| Psychoeducational video | Behavioural | – |
| Infant massage | Behavioural | – |
| Brazelton Neonatal Behavioral Assessment Scale | Behavioural | – |
Primary outcome
Anthropometrics (weight, height, head circumference), Bayley Scales of Infant Development, infant behavioral problems and behavioral competencies, maternal sensitivity, infant-parent attachment
Time frame: collected at 4, 12, and 24 months of infant age
1 secondary outcome
Maternal self-efficacy, parenting stress, perceptions of infant temperament
Time frame: Collected at 4, 12, and 24 months of infant age
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 20 Jun 2007.
- Results publication: PubMed 16100501Teti DM, Hess CR, O'Connell M. Parental perceptions of infant vulnerability in a preterm sample: prediction from maternal adaptation to parenthood during the neonatal period. J Dev Behav Pediatr. 2005 Aug;26(4):283-92. doi: 10.1097/00004703-200508000-00004.
- Results publicationTeti, D. M., & Killeen, L. (in press). The role of parental states of mind in effecting parental commitment to an intervention program for premature infants and their parents. In H. Steele & M. Steele (Eds.), The Adult Attachment Interview in Clinical Context. New York: Guilford Press.
- Results publicationCandelaria, MA, O'Connell, MA, & Teti, DM. (2006). Cumulative psychosocial and medical risk as predictors of early infant development and parenting stress in an African-American preterm sample. Journal of Applied Developmental Psychology, 27(6), 588-597.
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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.
Douglas M. Teti, Ph.D. principal investigator
The Pennsylvania State University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational video, Infant massage and Brazelton Neonatal Behavioral Assessment Scale in people with Premature Birth, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 5 sites 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 3 inclusion and 4 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 20 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Anthropometrics (weight, height, head circumference), Bayley Scales of Infant Development, infant behavioral problems and behavioral competencies, maternal sensitivity, infant-parent attachment (time frame: collected at 4, 12, and 24 months of infant age). 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 NCT00056680, which also lists 3 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 20 Jun 2007.