Anticipated outcomes of the intervention include fewer reports of supported child abuse or neglect filings in the child's first year of life, fewer days in out-of-home placement; fewer terminations of parental rights in the child's first year of life; and improvements in family functions overall e. Project RESPECT-Plus Recovery, Empowerment, Social Services, Prenatal care, Education, and Community Treatment-Plus is a randomized controlled trial of promising and evidence-based practices designed to strengthen family protective factors and improve health permanency and well-being outcomes for children born to mothers in treatment for opioid use disorder.
A total of subjects - mothers - will be enrolled into the study and randomized post-partum to receive the intervention or standard of care, and will be followed for 1 year. In order to provide continuity of care from the prenatal to pediatric primary care setting, participants receiving prenatal care at the RESPECT Clinic are recruited during their third trimester of pregnancy. After consent, the initial baseline data collection is scheduled and once the infants are born and pass the eligibility screening term birth and no major congenital abnormalities or developmental disabilities , mothers and their infants are randomized into the intervention RESPECT-Plus or control standard of care group.
The intervention is delivered by a family specialist who, with the permission of the mother, will attend routine well-child visits so as to collaborate with providers in the child's medical home and parent through the medical visit. As desired by the mother, home visits, other face-to-face contacts, telephone calls, and text messages will assist in addressing social determinants of health, improve the mother's knowledge of child development and parenting, and link families to community resources to address existing concrete support needs.
The family specialist will receive support and training by a licensed clinical social worker and the Medical-Legal Partnership, Boston MLP Boston to identify legal and social needs that may affect a child's health and development and to take action either by helping family members advocate for themselves, or by referring them to an appropriate public health, legal, or social service agency or resources.
Both the intervention and standard of care groups will be evaluated by research evaluators not associated with the intervention at baseline, and when the child is 6 and 12 months old. Anticipated outcomes of the intervention include fewer reports of supported child abuse or neglect filings in the child's first year of life, fewer days in out-of-home placement and terminations of parental rights in the child's first year of life, and improvements in family functions overall e.
During their infant's hospital stay, the FS will schedule a convenient time to meet the subjects mothers to educate them on infant soothing techniques. With permission from the mother, the FS will join the subjects during their infant's routine well-child visits at the pediatric primary site. Optional home visiting provides another meeting opportunity between the subjects and FS. DCF will provide information concerning any changes in custody.
The study outcome will be time to change in custody as primary outcome. Secondary Outcome Measures : 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 well-being [ Time Frame: Outcomes will be measured at baseline, 6 months, and 12 months child-related measures only administered at 6 and 12 months post-birth ] This composite measure involves evaluating important factors associated with parenting.
Other Outcome Measures: Process Data [ Time Frame: Measures will be taken at 6 and 12 months ] This composite measure involves examining patient-reported information on services received, such as SNAP Special Supplemental Nutrition Program for Women, Infants, and Children , etc and documentation from Family Specialists on support services given during the Family Specialist encounters including phone, in person, coordinated primary care visits, and home visits if applicable. The time devoted to the care of each participating family will be collected and collated.
This data collection will be documented in a Microsoft Access database. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Last Update Posted : January 16, Study Description. Detailed Description:. We believe in you and your ability to make a positive change in your life, for you and your baby!
Our goal is to support you in your recovery while providing you with excellent medical and obstetric care. Jordana Price, MD Dept. Erica Holland, MD Dept. Emily Rosenthal, MD Dept.
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