Infant Development, Opioid-Related Disorders, Parent-Child Relations, Parenting
Conditions
Brief summary
This study will assess the efficacy of the modified Attachment and Biobehavioral Catch-Up Intervention, adapted for use with peripartum mothers receiving medication-assisted treatment for opioid use disorder. The investigators expect that mothers who receive the modified Attachment and Biobehavioral Catch-up Intervention will show more nurturing and sensitive parenting and more adaptive physiological regulation than parents who receive a control intervention. The investigators expect that infants whose mothers receive the modified Attachment and Biobehavioral Catch-up will show better outcomes in attachment, behavior, and physiological regulation compared to infants of parents who receive the control intervention.
Detailed description
Peripartum mothers will be randomly assigned to receive the modified ABC intervention or the control intervention (modified DEF). Hypotheses relate to parent and child outcomes associated with the intervention. Hypothesis 1: Compared to mothers who receive the control intervention, mothers who receive the ABC intervention will show more nurturing and sensitive parenting, enhanced neural activity during parenting-relevant tasks, and more normative patterns of DNA methylation, autonomic nervous system activity, and cortisol production. Hypothesis 2: Compared to infants of mothers who receive the control intervention, infants of mothers who receive the ABC intervention will show more organized and secure attachment patterns, better behavioral regulation during stressors, more advanced social-emotional development, and more normative patterns of DNA methylation, autonomic nervous system activity, and cortisol production. Hypothesis 3: Enhanced maternal sensitivity will mediate effects of the ABC intervention on improved infant outcomes.
Interventions
BEHAVIORALModified Attachment and Biobehavioral Catch-up
Intervention targets include enhancing nurturance and following the child's lead, as well as supporting use of kangaroo care, swaddling, and breastfeeding.
BEHAVIORALModified Developmental Education for Families
Intervention targets include supporting developmental monitoring and parental engagement in activities that promote cognitive and motor development.
Sponsors
University of Delaware
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* In third trimester of pregnancy or up to one month postpartum * Receiving medication-assisted treatment for opioid use disorder
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal emotion regulation | Pre-intervention (third trimester of gestation or up to one month postpartum) | Mothers will report on their emotion regulation using the Difficulties with Emotion Regulation Scale - Short Form (DERS-SF). The DERS-SF consists of 18 items rated on a scale from 1-almost never to 5-almost always. The DERS-SF yields six subscales (strategies, non-acceptance, impulse, goals, awareness, and clarity), each of which range from 3 to 15, and one total score, which ranges from 18 to 90. Higher scores indicate greater emotion dysregulation. |
| Infant diurnal cortisol production | Infant age 3 months | Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time. |
| Infant behavioral regulation - Still Face Paradigm | Infant age 6 months | Behavioral coding of emotion reactivity and regulation will be conducted from video recordings of the Still Face Paradigm, a mild social stressor. |
| Infant behavioral regulation - Arm Restraint Task | Infant age 12 months | Behavioral coding of emotion reactivity and regulation will be conducted from video recordings of the Arm Restraint Task, a mild stressor. |
| Infant attachment | Infant age 12 months | Infant attachment will be assessed using the Strange Situation. |
| Infant cognitive development | Infant age 3 months | Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire. |
| Infant motor development | Infant age 3 months | Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire. |
| Infant social-emotional development | Infant age 3 months | Infant social-emotional development will be assessed through maternal report on the Ages and Stages Questionnaire: Social-Emotional. |
| Infant social-emotional problems | Infant age 12 months | Infant social-emotional problems will be assessed through maternal report on the Brief Infant-Toddler Social Emotional Assessment. |
| Maternal self-efficacy | Pre-intervention (third trimester of gestation or up to one month postpartum) | Mothers will report on their parenting self-efficacy using the Maternal Self-Efficacy Scale. Mothers will rate their self-efficacy for each of ten items (nine discrete parenting behaviors and one global parenting item) on a 4-point scale from 1-not good at all to 4-very good. Scores are summed to form a total maternal self-efficacy composite (possible range = 10-40), where higher scores indicated more maternal self-efficacy. |
| Maternal sensitivity | Pre-intervention (third trimester of gestation or up to one month postpartum) | Maternal sensitivity will be coded observationally from maternal interactions with an infant simulator pre-programmed to coo and then cry. Mothers will be coded for sensitivity, nurturance, intrusiveness, detachment, and positive regard, on 5 point scales from 1-Not at all characteristic to 5-Highly characteristic. Higher scores on sensitivity, nurturance, and positive regard represent more positive parenting, whereas higher scores on nurturance and detachment represent less positive parenting. |
| Maternal methylation of μ-opioid receptor (OPRM1) gene | Pre-intervention (third trimester of gestation or up to one month postpartum) | Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva. |
| Maternal methylation of oxytocin receptor (OXTR) gene | Pre-intervention (third trimester of gestation or up to one month postpartum) | Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva. |
| Infant methylation of μ-opioid receptor (OPRM1) gene | Infant age 3 months | Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva. |
| Infant methylation of oxytocin receptor (OXTR) gene | Infant age 3 months | Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva. |
| Maternal neural activity (EEG) - Own child-other child task | Pre-intervention (third trimester of gestation or up to one month postpartum) | Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing photos of their own infants, familiar infants, and unfamiliar infants. |
| Maternal neural activity (EEG) - Reward sensitivity task | Pre-intervention (third trimester of gestation or up to one month postpartum) | Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing images from four categories: opioid-related images, baby pictures, positive images, and neutral images. |
| Maternal neural activity (EEG) - Child emotion task | Pre-intervention (third trimester of gestation or up to one month postpartum) | Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing images of children crying, laughing, and showing neutral expressions. |
| Maternal parasympathetic nervous system activity | Pre-intervention (third trimester of gestation or up to one month postpartum) | Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia. |
| Maternal sympathetic nervous system activity | Pre-intervention (third trimester of gestation or up to one month postpartum) | Maternal sympathetic nervous system activity will be assessed using pre-ejection period. |
| Infant parasympathetic nervous system activity | Infant age 3 months | Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia. |
| Infant sympathetic nervous system activity | Infant age 3 months | Infant sympathetic nervous system activity will be assessed using pre-ejection period. |
| Maternal diurnal cortisol production | Pre-intervention (third trimester of gestation or up to one month postpartum) | Maternal diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal substance use - questionnaire | Pre-intervention (third trimester of gestation or up to one month postpartum) | Mothers will report their history of substance use using the NIDA ASSIST questionnaire. |
| Maternal depressive symptoms | Pre-intervention (third trimester of gestation or up to one month postpartum) | Maternal depressive symptoms will be self-reported using the Beck Depression Inventory. |
| Infant physical growth | Infant age 3 months | Infant physical growth will be assessed using weight, length, and head circumference. |
| Maternal experiences during labor and delivery | Infant age 3 months | Mothers will report on their experiences during labor and delivery using the Birth Satisfaction Scale-Revised questionnaire (BSS-R). This measure consists of ten items rated on a 5-point scale from 1-Strongly Disagree to 5-Strongly Agree. The total score ranges from 10-50, where higher scores represent more birth satisfaction. |
| Home environment | Infant age 3 months | The home environment will be assessed using the Cognitive Stimulation subscale of the HOME Short Form, a combination of observation (two items) and maternal report (seven items). Observation items are binary (yes/no), and mother-report items are rated on a Likert-type scale and dichotomized. Dichotomous items are summed to form a total score (range 0-9), with higher scores indicating more cognitive stimulation. |
| Maternal reward responsiveness | Pre-intervention (third trimester of gestation or up to one month postpartum) | Mothers will report their reward responsiveness using the Reward Responsiveness Scale. This is an 8-item scale rated on a 4-point scale from 1-Strong Disagreement to 4-Strong Agreement. The total score ranges from 8 to 32, with higher scores representing greater reward responsiveness. |
| Maternal sleep | Pre-intervention (third trimester of gestation or up to one month postpartum) | Mothers will report on their sleep habits using the Pittsburgh Sleep Quality Index. |
| Infant sleep | Infant age 3 months | Mothers will report on their infant's sleep habits using the Brief Infant Sleep Questionnaire. |
| Maternal substance use - interview | Pre-intervention (third trimester of gestation or up to one month postpartum) | The Timeline Followback Interview will be used to assess maternal use of opioids, tobacco, alcohol, marijuana, and other substances. |
Countries
United States
Outcome results
None listed