This trial is active, not recruiting.

Conditions neonatal abstinence syndrome, child development, child abuse, child neglect
Treatment respect - plus
Sponsor Boston Medical Center
Start date July 2013
End date August 2016
Trial size 200 participants
Trial identifier NCT02334111, HHS-2012-ACF-ACYF-CB-0286


The impact of substance-abusing parents on the child welfare system is undeniable.

An estimated 40% to 80% of the 3 million children who come to the attention of the child welfare system each year live in families with alcohol and other drug problems. Children born to parents with substance use disorders are three to four times more likely to suffer abuse or neglect.

The current standard of care: pregnant women who are being treated for opiate dependence at Boston Medical Center (BMC) receive all their prenatal care in the RESPECT clinic in the BMC Department of Obstetrics. Once the child is born, BMC staff files a report of suspected child abuse and neglect in accordance with the Massachusetts Gen. laws section 51A. The state Department of Children and Families makes a determination regarding the disposition of these families. Medically, most of these children's suffer from narcotic withdrawal and are treated at Boston Medical Center in the patient pediatric unit. Average length of stay for neonatal abstinence syndrome is approximately 21 days. Following treatment for narcotic withdrawal, the infant patients are discharged to follow-up with routine pediatric primary care. Currently, approximately 85% of infants born exposed to narcotics go home with their mothers, the remainder receive substitute care, either with other family member or foster care.

This investigation is a randomized controlled trial of RESPECT-Plus, a continuum of promising and/or evidence-based practices that will strengthen family protective factors until the opioid-exposed infant reaches one year of age, thereby preventing child maltreatment. Anticipated outcomes of the intervention include fewer reports of suspected child abuse/neglect, fewer infant days in out-of-home placement in the first year of life, fewer terminations of parental rights and improvements in family functions (e.g. improved basic needs, improved parental resilience).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
(No Intervention)
Patients and families will receive standard of care.
Intervention (RESPECT-Plus) Group The three main components of intervention are: Project DULCE - a maltreatment prevention program that teaches parenting skills and child development to parents of newborns and also helps them meet their basic need for food, safe housing, income supports etc. Parent education in infant soothing techniques using Harvey Karp's "5S's" (Swaddling, Shushing, side/stomach position, swinging and sucking) and All Babies Cry
respect - plus
A RESPECT-Plus family specialist (FS) will deliver intervention to subjects randomized into the study's intervention arm. During infant's hospital stay, FS will schedule a convenient time to meet these subjects to educate them on infant soothing techniques. All Babies Cry consists of an 11-minute video program, a DVD for families to take home, a 28-page booklet, and social media. The 5 S's provides methods that can be used to calm a crying infant. FS will join infant's routine well-child visits at the pediatric primary site. Optional home visiting provides another meeting opportunity between subjects and FS. The American Academy of Pediatrics recommends 7 routine visits during the first year of life (1 wk;1,2,4,6,9,12 mos); FS will attend subject to availability and parent wishes.

Primary Outcomes

time to change in custody
time frame: up to 12 months

Secondary Outcomes

Improvements in parental resilience and parenting aligned with the Strengthening Families model (parental resilience, knowledge of parenting and child development, concrete supports, social connections, and child factors).
time frame: Outcomes will be measured at baseline, 6 months, and 12 months (child related measures only administered at 6, 12 months post-birth)

Eligibility Criteria

Male or female participants up to 21 days old.

Inclusion Criteria: 1. Opiate-dependent pregnant women receiving opiate-replacement therapy (methadone or BPH) treatment by licensed provider (mother) 2. Receives prenatal and obstetric care through Boston Medical Center's RESPECT clinic (mother) 3. Due date within 3 months at time of enrollment (Estimated Gestation Age >27 weeks) (mother) 4. 18 years and older (mother) 5. Singleton pregnancy (infant) 6. Intends to deliver at Boston Medical Center (mother) 7. Intends to remain in the Boston area after birth of child (mother) 8. Mother able to provide informed consent (not excluded by RESPECT staff) 9. No serious medical illness in infant such as sepsis, asphyxia, seizures, or respiratory failure (infant) 10. No major congenital abnormalities in infant including genetic syndromes (infant) 11. Gestational age at birth 36 weeks or greater defined by obstetrical estimate (infant) 12. Born at Boston Medical Center (infant) 13. Not incarcerated at the time of enrollment (mother) Exclusion Criteria: 1. Plans to voluntarily relinquish parental rights at birth 2. Does not speak English. 3. Estimated gestational age less than 36 weeks 4. Infant positive for serious congenital anomaly or developmental disability

Additional Information

Official title Project RESPECT-Plus: Recovery, Empowerment, Social Services, Prenatal Care, Education and Community Treatment-Plus.
Principal investigator Ruth Rose-Jacobs, Sc.D.
Description The two main components of the proposed project are: 1. Project DULCE (Developmental Understanding and Legal Collaboration for Everyone), a child maltreatment prevention program that teaches parenting skills and child development to parents of newborns and also helps them meet their basic needs for food, safe housing, income supports, etc. 2. Parent education in infant soothing techniques, using Harvey Karp's "5 S's" (Swaddling, shushing, side/stomach position, swinging and sucking) and All Babies Cry The two goals and associated objectives for RESPECT-Plus are to demonstrate the value of an integrated care model, RESPECT-Plus, on improving child well-being, safety, and permanency outcomes, and also to bring about significant improvements in family functioning aligned with the five protective factors in the Strengthening Families model (parental resilience, knowledge of parenting and child development, concrete supports, social connections, and child factors). A total of 400 subjects - 200 mothers - will be enrolled into the study and randomized post-partum to receive intervention or standard of care, and followed for 1 year. Their newborns will be subjects in the study.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Boston Medical Center.