Opioid-Related DisordersmABCNCT03891628
Modified ABC: A Home-based Parenting Program for Opioid-dependent Mothers and Their Infants
A study testing Modified Attachment and Biobehavioral Catch-up and Modified Developmental Education for Families in people with Opioid-Related Disorders and Parent-Child Relations, run by University of Delaware at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Opioid-Related Disorders, Parent-Child Relations, Infant Development
- What is being tested?
- Modified Attachment and Biobehavioral Catch-up and Modified Developmental Education for Families
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2018to 31 Mar 2021
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In third trimester of pregnancy or up to one month postpartum
- Receiving medication-assisted treatment for opioid use disorder
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modified Attachment and Biobehavioral Catch-Up for Mothers and Their Infants
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.
Read the 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.
- Being tested
- Modified Attachment and Biobehavioral Catch-up, Modified Developmental Education for Families
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Attachment and Biobehavioral Catch-upBehavioural
Also called mABC
Intervention targets include enhancing nurturance and following the child's lead, as well as supporting use of kangaroo care, swaddling, and breastfeeding.
Modified Developmental Education for FamiliesBehavioural
Also called mDEF
Intervention targets include supporting developmental monitoring and parental engagement in activities that promote cognitive and motor development.
| Study group | Role | What they receive |
|---|---|---|
| Modified ABC | Experimental | Modified Attachment and Biobehavioral Catch-Up (14 session in-home intervention with parents and infants present) and Safe Environment for Every Kid (1 to 2 in-home resource visits) Receives: Behavioral: Modified Attachment and Biobehavioral Catch-up |
| Modified DEF | Active comparator | Modified Developmental Education for Families (14 session in-home intervention with parents and infants present) and Safe Environment for Every Kid (1 to 2 in-home resource visits) Receives: Behavioral: Modified Developmental Education for Families |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal sensitivity
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.
Measured: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal sensitivity
Maternal sensitivity will be coded observationally from mother-infant play interactions, in which mothers will be given toys and asked to play as they normally would. 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.
Measured: Infant age 3 months
Maternal sensitivity
Maternal sensitivity will be coded observationally from mother-infant play interactions, in which mothers will be given toys and asked to play as they normally would. 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.
Measured: Infant age 6 months
Maternal sensitivity
Maternal sensitivity will be coded observationally from mother-infant play interactions, in which mothers will be given toys and asked to play as they normally would. 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.
Measured: Infant age 12 months
Maternal methylation of μ-opioid receptor (OPRM1) gene
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measured: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal methylation of μ-opioid receptor (OPRM1) gene
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measured: Infant age 3 months
Maternal methylation of μ-opioid receptor (OPRM1) gene
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measured: Infant age 6 months
Maternal methylation of μ-opioid receptor (OPRM1) gene
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measured: Infant age 12 months
Maternal methylation of oxytocin receptor (OXTR) gene
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measured: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal methylation of oxytocin receptor (OXTR) gene
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measured: Infant age 3 months
Maternal methylation of oxytocin receptor (OXTR) gene
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measured: Infant age 6 months
Maternal methylation of oxytocin receptor (OXTR) gene
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measured: Infant age 12 months
Infant methylation of μ-opioid receptor (OPRM1) gene
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measured: Infant age 3 months
Infant methylation of μ-opioid receptor (OPRM1) gene
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measured: Infant age 6 months
Infant methylation of μ-opioid receptor (OPRM1) gene
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measured: Infant age 12 months
Infant methylation of oxytocin receptor (OXTR) gene
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measured: Infant age 3 months
Infant methylation of oxytocin receptor (OXTR) gene
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measured: Infant age 6 months
Infant methylation of oxytocin receptor (OXTR) gene
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Measured: Infant age 12 months
Maternal neural activity (EEG) - Own child-other child task
Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing photos of their own infants, familiar infants, and unfamiliar infants.
Measured: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal neural activity (EEG) - Own child-other child task
Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing photos of their own infants, familiar infants, and unfamiliar infants.
Measured: Infant age 12 months
Maternal neural activity (EEG) - Reward sensitivity task
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.
Measured: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal neural activity (EEG) - Reward sensitivity task
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.
Measured: Infant age 12 months
Maternal neural activity (EEG) - Child emotion task
Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing images of children crying, laughing, and showing neutral expressions.
Measured: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal neural activity (EEG) - Child emotion task
Maternal event-related potentials will be assessed using electroencephalogram (EEG) while viewing images of children crying, laughing, and showing neutral expressions.
Measured: Infant age 12 months
Maternal parasympathetic nervous system activity
Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Measured: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal sympathetic nervous system activity
Maternal sympathetic nervous system activity will be assessed using pre-ejection period.
Measured: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal parasympathetic nervous system activity
Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Measured: Infant age 3 months
Maternal sympathetic nervous system activity
Maternal sympathetic nervous system activity will be assessed using pre-ejection period.
Measured: Infant age 3 months
Maternal parasympathetic nervous system activity
Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Measured: Infant age 6 months
Maternal sympathetic nervous system activity
Maternal sympathetic nervous system activity will be assessed using pre-ejection period.
Measured: Infant age 6 months
Maternal parasympathetic nervous system activity
Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Measured: Infant age 12 months
Maternal sympathetic nervous system activity
Maternal sympathetic nervous system activity will be assessed using pre-ejection period.
Measured: Infant age 12 months
Infant parasympathetic nervous system activity
Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Measured: Infant age 3 months
Infant sympathetic nervous system activity
Infant sympathetic nervous system activity will be assessed using pre-ejection period.
Measured: Infant age 3 months
Infant parasympathetic nervous system activity
Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Measured: Infant age 6 months
Infant sympathetic nervous system activity
Infant sympathetic nervous system activity will be assessed using pre-ejection period.
Measured: Infant age 6 months
Infant parasympathetic nervous system activity
Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Measured: Infant age 12 months
Infant sympathetic nervous system activity
Infant sympathetic nervous system activity will be assessed using pre-ejection period.
Measured: Infant age 12 months
Maternal diurnal cortisol production
Maternal diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
Measured: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal diurnal cortisol production
Maternal diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
Measured: Infant age 12 months
Infant diurnal cortisol production
Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
Measured: Infant age 3 months
Infant diurnal cortisol production
Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
Measured: Infant age 6 months
Infant diurnal cortisol production
Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
Measured: Infant age 12 months
Infant behavioral regulation - Still Face Paradigm
Behavioral coding of emotion reactivity and regulation will be conducted from video recordings of the Still Face Paradigm, a mild social stressor.
Measured: Infant age 6 months
Infant behavioral regulation - Arm Restraint Task
Behavioral coding of emotion reactivity and regulation will be conducted from video recordings of the Arm Restraint Task, a mild stressor.
Measured: Infant age 12 months
Infant attachment
Infant attachment will be assessed using the Strange Situation.
Measured: Infant age 12 months
Infant cognitive development
Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire.
Measured: Infant age 3 months
Infant motor development
Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire.
Measured: Infant age 3 months
Infant social-emotional development
Infant social-emotional development will be assessed through maternal report on the Ages and Stages Questionnaire: Social-Emotional.
Measured: Infant age 3 months
Infant cognitive development
Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire.
Measured: Infant age 6 months
Infant motor development
Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire.
Measured: Infant age 6 months
Infant social-emotional development
Infant social-emotional development will be assessed through maternal report on the Ages and Stages Questionnaire: Social-Emotional.
Measured: Infant age 6 months
Infant cognitive development
Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire.
Measured: Infant age 12 months
Infant motor development
Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire.
Measured: Infant age 12 months
Infant social-emotional development
Infant social-emotional development will be assessed through maternal report on the Ages and Stages Questionnaire: Social-Emotional.
Measured: Infant age 12 months
Infant social-emotional problems
Infant social-emotional problems will be assessed through maternal report on the Brief Infant-Toddler Social Emotional Assessment.
Measured: Infant age 12 months
Maternal self-efficacy
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.
Measured: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal self-efficacy
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.
Measured: Infant age 12 months
Maternal emotion regulation
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.
Measured: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal emotion regulation
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.
Measured: Infant age 12 months
Secondary outcomes (25)
Maternal substance use - interview
The Timeline Followback Interview will be used to assess maternal use of opioids, tobacco, alcohol, marijuana, and other substances.
Measured: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal substance use - interview
The Timeline Followback Interview will be used to assess maternal use of opioids, tobacco, alcohol, marijuana, and other substances.
Measured: Infant age 6 months
Maternal substance use - interview
The Timeline Followback Interview will be used to assess maternal use of opioids, tobacco, alcohol, marijuana, and other substances.
Measured: Infant age 12 months
Maternal substance use - questionnaire
Mothers will report their history of substance use using the NIDA ASSIST questionnaire.
Measured: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal substance use - questionnaire
Mothers will report recent substance use using the NIDA Quick Screen questionnaire.
Measured: Infant age 3 months
Maternal substance use - questionnaire
Mothers will report recent substance use using the NIDA Quick Screen questionnaire.
Measured: Infant age 6 months
Maternal substance use - questionnaire
Mothers will report recent substance use using the NIDA Quick Screen questionnaire.
Measured: Infant age 12 months
Maternal depressive symptoms
Maternal depressive symptoms will be self-reported using the Beck Depression Inventory.
Measured: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal depressive symptoms
Maternal depressive symptoms will be self-reported using the Beck Depression Inventory.
Measured: Infant age 3 months
Maternal depressive symptoms
Maternal depressive symptoms will be self-reported using the Beck Depression Inventory.
Measured: Infant age 6 months
Maternal depressive symptoms
Maternal depressive symptoms will be self-reported using the Beck Depression Inventory.
Measured: Infant age 12 months
Infant physical growth
Infant physical growth will be assessed using weight, length, and head circumference.
Measured: Infant age 3 months
Infant physical growth
Infant physical growth will be assessed using weight, length, and head circumference.
Measured: Infant age 6 months
Infant physical growth
Infant physical growth will be assessed using weight, length, and head circumference.
Measured: Infant age 12 months
Maternal experiences during labor and delivery
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.
Measured: Infant age 3 months
Home environment
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.
Measured: Infant age 3 months
Maternal reward responsiveness
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.
Measured: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal reward responsiveness
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.
Measured: Infant age 12 months
Maternal sleep
Mothers will report on their sleep habits using the Pittsburgh Sleep Quality Index.
Measured: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal sleep
Mothers will report on their sleep habits using the Pittsburgh Sleep Quality Index.
Measured: Infant age 3 months
Maternal sleep
Mothers will report on their sleep habits using the Pittsburgh Sleep Quality Index.
Measured: Infant age 6 months
Maternal sleep
Mothers will report on their sleep habits using the Pittsburgh Sleep Quality Index.
Measured: Infant age 12 months
Infant sleep
Mothers will report on their infant's sleep habits using the Brief Infant Sleep Questionnaire.
Measured: Infant age 3 months
Infant sleep
Mothers will report on their infant's sleep habits using the Brief Infant Sleep Questionnaire.
Measured: Infant age 6 months
Infant sleep
Mothers will report on their infant's sleep habits using the Brief Infant Sleep Questionnaire.
Measured: Infant age 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start13 Aug 2018
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-Related DisordersStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Dozier, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891628
- Sponsor's protocol ID
- PSYC412125
- Acronym
- mABC
- Status last verified
- Aug 2021
- First submitted
- 21 Feb 2019
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tabachnick AR, Eiden RD, Labella MH, Dozier M. Effects of an attachment-based intervention on autonomic regulation among opioid-exposed infants. Dev Psychobiol. 2022 Sep;64(6):e22286. doi: 10.1002/dev.22286.
PubMed 35748625
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Attachment and Biobehavioral Catch-Up for Mothers and Their Infants
- ClinicalTrials.gov ID
- NCT03891628
- Acronym / sponsor ID
- mABC / PSYC412125
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 27 Mar 2019 (actual)
- 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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified ABC | Experimental | Behavioral: Modified Attachment and Biobehavioral Catch-upModified Attachment and Biobehavioral Catch-Up (14 session in-home intervention with parents and infants present) and Safe Environment for Every Kid (1 to 2 in-home resource visits) |
| Modified DEF | Active comparator | Behavioral: Modified Developmental Education for FamiliesModified Developmental Education for Families (14 session in-home intervention with parents and infants present) and Safe Environment for Every Kid (1 to 2 in-home resource visits) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- In third trimester of pregnancy or up to one month postpartum
- Receiving medication-assisted treatment for opioid use disorder
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Modified Attachment and Biobehavioral Catch-upAlso: mABCIntervention targets include enhancing nurturance and following the child's lead, as well as supporting use of kangaroo care, swaddling, and breastfeeding. | Behavioural | Modified ABC |
| Modified Developmental Education for FamiliesAlso: mDEFIntervention targets include supporting developmental monitoring and parental engagement in activities that promote cognitive and motor development. | Behavioural | Modified DEF |
Primary outcome
Maternal sensitivity
Time frame: 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 sensitivity
Time frame: Infant age 3 months
Maternal sensitivity will be coded observationally from mother-infant play interactions, in which mothers will be given toys and asked to play as they normally would. 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 sensitivity
Time frame: Infant age 6 months
Maternal sensitivity will be coded observationally from mother-infant play interactions, in which mothers will be given toys and asked to play as they normally would. 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 sensitivity
Time frame: Infant age 12 months
Maternal sensitivity will be coded observationally from mother-infant play interactions, in which mothers will be given toys and asked to play as they normally would. 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
Time frame: 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 μ-opioid receptor (OPRM1) gene
Time frame: Infant age 3 months
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Maternal methylation of μ-opioid receptor (OPRM1) gene
Time frame: Infant age 6 months
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Maternal methylation of μ-opioid receptor (OPRM1) gene
Time frame: Infant age 12 months
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Maternal methylation of oxytocin receptor (OXTR) gene
Time frame: 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
Time frame: Infant age 3 months
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Maternal methylation of oxytocin receptor (OXTR) gene
Time frame: Infant age 6 months
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Maternal methylation of oxytocin receptor (OXTR) gene
Time frame: Infant age 12 months
Maternal methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Infant methylation of μ-opioid receptor (OPRM1) gene
Time frame: Infant age 3 months
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Infant methylation of μ-opioid receptor (OPRM1) gene
Time frame: Infant age 6 months
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Infant methylation of μ-opioid receptor (OPRM1) gene
Time frame: Infant age 12 months
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Infant methylation of oxytocin receptor (OXTR) gene
Time frame: 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
Time frame: Infant age 6 months
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Infant methylation of oxytocin receptor (OXTR) gene
Time frame: Infant age 12 months
Infant methylation will be assessed using direct bisulfite sequencing of DNA extracted from saliva.
Maternal neural activity (EEG) - Own child-other child task
Time frame: 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) - Own child-other child task
Time frame: Infant age 12 months
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
Time frame: 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) - Reward sensitivity task
Time frame: Infant age 12 months
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
Time frame: 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 neural activity (EEG) - Child emotion task
Time frame: Infant age 12 months
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
Time frame: 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
Time frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal sympathetic nervous system activity will be assessed using pre-ejection period.
Maternal parasympathetic nervous system activity
Time frame: Infant age 3 months
Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Maternal sympathetic nervous system activity
Time frame: Infant age 3 months
Maternal sympathetic nervous system activity will be assessed using pre-ejection period.
Maternal parasympathetic nervous system activity
Time frame: Infant age 6 months
Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Maternal sympathetic nervous system activity
Time frame: Infant age 6 months
Maternal sympathetic nervous system activity will be assessed using pre-ejection period.
Maternal parasympathetic nervous system activity
Time frame: Infant age 12 months
Maternal parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Maternal sympathetic nervous system activity
Time frame: Infant age 12 months
Maternal sympathetic nervous system activity will be assessed using pre-ejection period.
Infant parasympathetic nervous system activity
Time frame: Infant age 3 months
Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Infant sympathetic nervous system activity
Time frame: Infant age 3 months
Infant sympathetic nervous system activity will be assessed using pre-ejection period.
Infant parasympathetic nervous system activity
Time frame: Infant age 6 months
Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Infant sympathetic nervous system activity
Time frame: Infant age 6 months
Infant sympathetic nervous system activity will be assessed using pre-ejection period.
Infant parasympathetic nervous system activity
Time frame: Infant age 12 months
Infant parasympathetic nervous system activity will be assessed using respiratory sinus arrhythmia.
Infant sympathetic nervous system activity
Time frame: Infant age 12 months
Infant sympathetic nervous system activity will be assessed using pre-ejection period.
Maternal diurnal cortisol production
Time frame: 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.
Maternal diurnal cortisol production
Time frame: Infant age 12 months
Maternal diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
Infant diurnal cortisol production
Time frame: Infant age 3 months
Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
Infant diurnal cortisol production
Time frame: Infant age 6 months
Infant diurnal cortisol production will be assessed through salivary cortisol levels collected at wake-time and bed-time.
Infant diurnal cortisol production
Time frame: Infant age 12 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
Time frame: 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
Time frame: 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
Time frame: Infant age 12 months
Infant attachment will be assessed using the Strange Situation.
Infant cognitive development
Time frame: Infant age 3 months
Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire.
Infant motor development
Time frame: Infant age 3 months
Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire.
Infant social-emotional development
Time frame: Infant age 3 months
Infant social-emotional development will be assessed through maternal report on the Ages and Stages Questionnaire: Social-Emotional.
Infant cognitive development
Time frame: Infant age 6 months
Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire.
Infant motor development
Time frame: Infant age 6 months
Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire.
Infant social-emotional development
Time frame: Infant age 6 months
Infant social-emotional development will be assessed through maternal report on the Ages and Stages Questionnaire: Social-Emotional.
Infant cognitive development
Time frame: Infant age 12 months
Infant cognitive development will be assessed through maternal report on the Ages and Stages Questionnaire.
Infant motor development
Time frame: Infant age 12 months
Infant motor development will be assessed through maternal report on the Ages and Stages Questionnaire.
Infant social-emotional development
Time frame: Infant age 12 months
Infant social-emotional development will be assessed through maternal report on the Ages and Stages Questionnaire: Social-Emotional.
Infant social-emotional problems
Time frame: 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
Time frame: 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 self-efficacy
Time frame: Infant age 12 months
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 emotion regulation
Time frame: 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.
Maternal emotion regulation
Time frame: Infant age 12 months
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.
25 secondary outcomes
Maternal substance use - interview
Time frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal substance use - interview
Time frame: Infant age 6 months
Maternal substance use - interview
Time frame: Infant age 12 months
Maternal substance use - questionnaire
Time frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal substance use - questionnaire
Time frame: Infant age 3 months
Maternal substance use - questionnaire
Time frame: Infant age 6 months
Maternal substance use - questionnaire
Time frame: Infant age 12 months
Maternal depressive symptoms
Time frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal depressive symptoms
Time frame: Infant age 3 months
Maternal depressive symptoms
Time frame: Infant age 6 months
Maternal depressive symptoms
Time frame: Infant age 12 months
Infant physical growth
Time frame: Infant age 3 months
Infant physical growth
Time frame: Infant age 6 months
Infant physical growth
Time frame: Infant age 12 months
Maternal experiences during labor and delivery
Time frame: Infant age 3 months
Home environment
Time frame: Infant age 3 months
Maternal reward responsiveness
Time frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal reward responsiveness
Time frame: Infant age 12 months
Maternal sleep
Time frame: Pre-intervention (third trimester of gestation or up to one month postpartum)
Maternal sleep
Time frame: Infant age 3 months
Maternal sleep
Time frame: Infant age 6 months
Maternal sleep
Time frame: Infant age 12 months
Infant sleep
Time frame: Infant age 3 months
Infant sleep
Time frame: Infant age 6 months
Infant sleep
Time frame: Infant age 12 months
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 1 Sep 2021.
- Derived from this study: PubMed 35748625Tabachnick AR, Eiden RD, Labella MH, Dozier M. Effects of an attachment-based intervention on autonomic regulation among opioid-exposed infants. Dev Psychobiol. 2022 Sep;64(6):e22286. doi: 10.1002/dev.22286.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Attachment and Biobehavioral Catch-up and Modified Developmental Education for Families in people with Opioid-Related Disorders and Parent-Child Relations, run by University of Delaware at 1 site 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 2 inclusion and 1 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 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Maternal sensitivity (time frame: Pre-intervention (third trimester of gestation or up to one month postpartum)). The study lists 60 primary outcomes in all. 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 NCT03891628, which also lists 1 linked publication.
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 1 Sep 2021.