Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
220 participants
INTERVENTIONAL
2005-03-31
2024-04-30
Brief Summary
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Detailed Description
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Hypothesis 1: Neglected children whose parents received the ABC intervention and low-risk comparison children will show better inhibitory control than neglected children whose parents received the DEF intervention.
Hypothesis 2: Children in the ABC intervention condition and low-risk comparison children will show better emotion regulation than children in the DEF condition.
Hypothesis 3: Children in the ABC intervention condition and comparison children will show less reactive aggression and less hostile attributional bias than children in the DEF condition.
Hypothesis 4: Children in the ABC condition and comparison children will show more normative cortisol production than children in the DEF condition.
Although we expect that sustained changes in parenting are critical for sustained changes in child behaviors, several alternative models will be tested. First, it is possible that when parents change as a result of the intervention in a child's infancy, there are positive outcomes for children regardless of whether the changes in parenting are sustained. If this is the case, early parenting will mediate the effects of the intervention when controlling for later parenting. Second, if concurrent parenting is what is critical to child functioning, current parenting will mediate intervention effects on child outcomes when controlling for early parenting. Third, longitudinal modeling of both parent and child behaviors allows for analysis of cross-lagged associations using structural equation modeling. Such modeling can examine concurrent and transactional associations between parent and child. We can also examine associations between change at behavioral and biological levels.
Longitudinal modeling will be used to examine models of change in parenting behaviors and how those influence child outcomes.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Attachment and Biobehavioral Catch-up
Attachment and Biobehavioral Catch-up - 10 session intervention to enhance nurturance and following the lead
Attachment and Biobehavioral Catch-up
Enhance nurturance and following the lead among parents. In-home intervention with parents and children present.
Developmental Education for Families
Developmental Education for Families - 10 session intervention that targets cognitive development
Developmental Education for Families
Enhance children's cognitive development. In-home intervention with parents and children present.
Low-risk
Low-risk comparison group
No interventions assigned to this group
Interventions
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Attachment and Biobehavioral Catch-up
Enhance nurturance and following the lead among parents. In-home intervention with parents and children present.
Developmental Education for Families
Enhance children's cognitive development. In-home intervention with parents and children present.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Years
8 Years
ALL
No
Sponsors
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University of Delaware
OTHER
Responsible Party
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Mary Dozier
Principal Investigator
Principal Investigators
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Mary Dozier, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Delaware
Locations
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University of Delaware
Newark, Delaware, United States
Countries
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References
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Valadez EA, Tottenham N, Korom M, Tabachnick AR, Pine DS, Dozier M. A Randomized Controlled Trial of a Parenting Intervention During Infancy Alters Amygdala-Prefrontal Circuitry in Middle Childhood. J Am Acad Child Adolesc Psychiatry. 2024 Jan;63(1):29-38. doi: 10.1016/j.jaac.2023.06.015. Epub 2023 Jun 27.
Hubbard JA, Bookhout MK, Zajac L, Moore CC, Dozier M. Children's social information processing predicts both their own and peers' conversational remarks. Dev Psychol. 2023 Jun;59(6):1153-1165. doi: 10.1037/dev0001510. Epub 2022 Dec 22.
Garnett M, Bernard K, Hoye J, Zajac L, Dozier M. Parental sensitivity mediates the sustained effect of Attachment and Biobehavioral Catch-up on cortisol in middle childhood: A randomized clinical trial. Psychoneuroendocrinology. 2020 Nov;121:104809. doi: 10.1016/j.psyneuen.2020.104809. Epub 2020 Jul 24.
Valadez EA, Tottenham N, Tabachnick AR, Dozier M. Early Parenting Intervention Effects on Brain Responses to Maternal Cues Among High-Risk Children. Am J Psychiatry. 2020 Sep 1;177(9):818-826. doi: 10.1176/appi.ajp.2020.20010011. Epub 2020 Jul 31.
Zajac L, Raby KL, Dozier M. Sustained effects on attachment security in middle childhood: results from a randomized clinical trial of the Attachment and Biobehavioral Catch-up (ABC) intervention. J Child Psychol Psychiatry. 2020 Apr;61(4):417-424. doi: 10.1111/jcpp.13146. Epub 2019 Nov 1.
Bernard K, Frost A, Jelinek C, Dozier M. Secure attachment predicts lower body mass index in young children with histories of child protective services involvement. Pediatr Obes. 2019 Jul;14(7):e12510. doi: 10.1111/ijpo.12510. Epub 2019 Jan 18.
Bernard K, Hostinar CE, Dozier M. Intervention effects on diurnal cortisol rhythms of Child Protective Services-referred infants in early childhood: preschool follow-up results of a randomized clinical trial. JAMA Pediatr. 2015 Feb;169(2):112-9. doi: 10.1001/jamapediatrics.2014.2369.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NIH R01 74374
Identifier Type: -
Identifier Source: org_study_id