Self-regulationMPHAMCNCT04241913
Mom Power With High-Adversity Mothers and Children
A study testing Mom Power Intervention in people with Self-regulation and Respiratory Sinus Arrhythmia, run by Tulane University at 2 sites in United States.
Trial summary
This study will evaluate whether the intervention, Mom Power, improves the self-regulation of mothers with a history of trauma and their children. The central hypothesis is that the intervention will shift behavioral and physiological self-regulation in mothers, children, and dyads to mitigate psychopathology risk. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Self-regulation, Respiratory Sinus Arrhythmia
- What is being tested?
- Mom Power Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2021to 1 Jun 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For moms: Mothers must be female, the biological mother, have an ACE score of 3 or more, speak English, and be 18 years or older.
- For children: Children must be between the ages of 2 and 5.
Who cannot join
- For mothers: No pacemaker or self-reported heart condition; no active maternal substance abuse or psychosis on screeners (Brown \& Rounds, 1995; Degenhardt, Hall, Korten, \& Jablensky, 2005).
- For children: No parent report of diagnosis of autism or global development delay, no parent report of pacemaker or heart condition
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Educare New Orleans
New Orleans, Louisiana, 70122
Kingsley House Early Head Start Preschool
New Orleans, Louisiana, 70130
About this study
Official title: A Randomized Controlled Trial to Improve Biobehavioral Regulation Among High-Adversity Mothers and Young Children
This study will evaluate whether the intervention, Mom Power, improves the self-regulation of mothers with a history of trauma and their children. The central hypothesis is that the intervention will shift behavioral and physiological self-regulation in mothers, children, and dyads to mitigate psychopathology risk.
Read the detailed description
Adverse childhood experiences (ACEs) are significant risk factors for psychopathology across the lifespan - risks that extend to the next generation, likely transmitted through both biological and behavioral pathways. Biobehavioral self-regulation and parenting are key candidates for transmission and potential points of intervention. However, nearly all intervention research takes a one-generation approach, measuring outcomes in the individual adult or child in treatment. Additionally, very little research has examined biomarkers of self-regulation in parents or children following treatment, and no known research has examined these processes in parents and young children simultaneously across treatment to explore bidirectional effects. There is a critical need to specify targets of two-generation interventions among high-adversity families to decrease intergenerational transmission of mental illness. The objective of this RCT is to determine whether Mom Power, an evidence-based two generation intervention for mothers with histories of trauma, enhances physiological and behavioral self-regulation in mothers and young children, testing mechanisms and examining bidirectional effects. The central hypothesis is that the intervention will shift behavioral and physiological (Respiratory Sinus Arrhythmia) self-regulation in mothers, children, and dyads to mitigate psychopathology risk. Three specific aims are proposed: 1) Examine intervention effects on children's biobehavioral self-regulation and psychopathology; 2) Examine intervention effects on mothers' biobehavioral self-regulation, psychopathology, and parenting behavior; and 3) Examine intergenerational change processes, including shifts in dyadic physiological and behavioral synchrony as well as bidirectional influences between mother and child self-regulation.
- Conditions
- Self-regulation, Respiratory Sinus Arrhythmia
- Being tested
- Mom Power Intervention
- Keywords
- biobehavioral self-regulation, psychopathology, parenting behavior
- Medical subject headings
- Self-Control, Arrhythmia, Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mom Power InterventionBehavioural
Mom Power is a 10-week therapeutic intervention for at-risk families that incorporates elements of several evidence based practices. It combines didactic material with mindbody self-care skills and in vivo practice to improve the quality of attachment between parent and child, and to reduce the psychopathology of at-risk parents. The child team component provides each child with one-on-one care focusing on meeting the child's social-emotional needs and providing attachment-related experiences within a developmental framework.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The treatment group receives the 10-week, group-based Mom Power intervention; intervention is provided to both mothers and children by trained providers. Treatment delivery will be consistent with the Mom Power manual. Receives: Behavioral: Mom Power Intervention |
| Waitlist control | No intervention | Participants randomized to waitlist control will not receive treatment during the experimental period; they will be offered treatment following completion of post- assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child RSA
Child self-regulation will be assessed physiologically with RSA baseline and RSA change during a parent-child dyadic task (Skowron et al., 2013); derived from electrocardiogram (ECG) collected using Mindware Technologies ambulatory mobile recorders during 1) 2-minute resting baseline; 2) a dyadic interaction task. ECG signals will be synchronized at acquisition with video and processed offline using Mindware software; research assistants will visually inspect for missing or erroneously identified R-peaks. Using spectral analysis of interbeat intervals, high-frequency heart rate variability will be extracted to quantify RSA within frequency bandwidths associated with respiration (.15-.40 for mothers; .24-1.04 for children), processed in 1-minute epochs averaged across tasks, and log-transformed.
Measured: Within 6 weeks of treatment group completion; approximately 4 months
Parent RSA
Parent self-regulation will be assessed physiologically with RSA baseline and RSA change during a parent-child dyadic task (Skowron et al., 2013); derived from electrocardiogram (ECG) collected using Mindware Technologies ambulatory mobile recorders during 1) 2-minute resting baseline; 2) a dyadic interaction task. ECG signals will be synchronized at acquisition with video and processed offline using Mindware software; research assistants will visually inspect for missing or erroneously identified R-peaks. Using spectral analysis of interbeat intervals, high-frequency heart rate variability will be extracted to quantify RSA within frequency bandwidths associated with respiration (.15-.40 for mothers; .24-1.04 for children), processed in 1-minute epochs averaged across tasks, and log-transformed.
Measured: Within 6 weeks of treatment group completion; approximately 4 months
Secondary outcomes (12)
Child Behavior - parent report
Child Behavior problems will be assessed via Total Score on parent report with the Child Behavior Checklist; higher scores indicate higher behavior problems (T score is a standardized score with a mean of 50).
Measured: Within 6 weeks of treatment group completion; approximately 4 months
Child Behavior - teacher report
Child Behavior problems will be assessed via teacher report with the Teacher Report Form; Achenbach \& Rescorla, 2000. Higher scores indicate higher behavior problems (T score is a standardized score with a mean of 50).
Measured: Within 6 weeks of treatment group completion; approximately 4 months
Dyadic synchrony - physiological
Dyadic synchrony will be assessed using EKG (derived from maternal and child RSA, as described above)
Measured: Within 6 weeks of treatment group completion; approximately 4 months
Dyadic synchrony - observational
Dyadic synchrony will be assessed observationally with the Coding Interactive Behavior (CIB) measure.
Measured: Within 6 weeks of treatment group completion; approximately 4 months
Parent psychopathology
Parents will report on their own depression symptoms (Patient Health Questionnaire-9 and Posttraumatic Checklist - 5); individual scales will be z-scored and summed, with higher values reflecting higher levels of psychopathology
Measured: Within 6 weeks of treatment group completion; approximately 4 months
Parent emotion regulation
Parents will report on their own emotion regulation using the difficulties in emotion regulation (DERS; range: 36-180); higher scores reflect more difficulties with emotion regulation.
Measured: Within 6 weeks of treatment group completion; approximately 4 months
Sensitive parenting behavior
Observational data derived from parent-child interactions will be examined, coding using the Coding Interactive Behavior measure (CIB). Higher scores reflect more sensitivity.
Measured: Within 6 weeks of treatment group completion; approximately 4 months
Parent self-efficacy
Parents will report on their own parenting efficacy using the Parent Sense of Competence scale; range: 17-102, higher scores reflect more self-efficacy
Measured: Within 6 weeks of treatment group completion; approximately 4 months
Parenting behavior
Parents will report on their own parenting behavior using the Conflict Tactic Scales - Parent Child (CTS-PC); range: 0-240, higher values reflect harsher parenting
Measured: Within 6 weeks of treatment group completion; approximately 4 months
Parent mental representation
Parents will complete an abbreviated version of the Working Model of the Child Interview; interviews will be coded into 3 categories, and it is hypothesized that proportion of "balanced" representations will be higher post-treatment.
Measured: Within 6 weeks of treatment group completion; approximately 4 months
Child Behavioral Self-Regulation, observational
Child self-regulation will be assessed behaviorally using observation (Preschool Self-Regulation Assessment); children's behavior will be observed during 6 tasks, and codes z-scored and summed; higher scores reflect higher effortful control/executive function
Measured: Within 6 weeks of treatment group completion; approximately 4 months
Child Behavioral Self-Regulation, parent report
Child self-regulation will also be assessed by parent-report (Social Competence Scale - Emotion Regulation); range: 0-48; higher scores reflect higher self-regulation
Measured: Within 6 weeks of treatment group completion; approximately 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Jun 2021 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Why it stopped: Due to COVID-19 and pandemic-related mitigation strategies, we were forced to alter procedures prior to the enrolling of participants into this trial. We will submit a new protocol for our adapted trial, launching at a later date.
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 Self-regulationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two arms: an experimental group receiving the Mom Power group intervention over 10 weeks, and a wait list control group. Treatment delivery will be consistent with the Mom Power manual. The waitlist control group will be offered to participate in the intervention following the trial period.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Sarah Gray, Tulane University
- Investigators
- Sarah A Gray, PhD, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241913
- Sponsor's protocol ID
- 2018-2012
- Other IDs
- 1K23MH119047-01
- Acronym
- MPHAMC
- Status last verified
- Jun 2021
- First submitted
- 10 Jan 2020
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosenblum KL, Muzik M, Morelen DM, Alfafara EA, Miller NM, Waddell RM, Schuster MM, Ribaudo J. A community-based randomized controlled trial of Mom Power parenting intervention for mothers with interpersonal trauma histories and their young children. Arch Womens Ment Health. 2017 Oct;20(5):673-686. doi: 10.1007/s00737-017-0734-9. Epub 2017 Jun 25.
PubMed 28647759
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Improve Biobehavioral Regulation Among High-Adversity Mothers and Young Children
- ClinicalTrials.gov ID
- NCT04241913
- Acronym / sponsor ID
- MPHAMC / 2018-2012
- Conditions
- Self-regulation, Respiratory Sinus Arrhythmia
- Keywords
- biobehavioral self-regulation, psychopathology, parenting behavior
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to COVID-19 and pandemic-related mitigation strategies, we were forced to alter procedures prior to the enrolling of participants into this trial. We will submit a new protocol for our adapted trial, launching at a later date.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 27 Jan 2020 (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 evaluate whether the intervention, Mom Power, improves the self-regulation of mothers with a history of trauma and their children. The central hypothesis is that the intervention will shift behavioral and physiological self-regulation in mothers, children, and dyads to mitigate psychopathology risk.
Detailed description
Adverse childhood experiences (ACEs) are significant risk factors for psychopathology across the lifespan - risks that extend to the next generation, likely transmitted through both biological and behavioral pathways. Biobehavioral self-regulation and parenting are key candidates for transmission and potential points of intervention. However, nearly all intervention research takes a one-generation approach, measuring outcomes in the individual adult or child in treatment. Additionally, very little research has examined biomarkers of self-regulation in parents or children following treatment, and no known research has examined these processes in parents and young children simultaneously across treatment to explore bidirectional effects. There is a critical need to specify targets of two-generation interventions among high-adversity families to decrease intergenerational transmission of mental illness. The objective of this RCT is to determine whether Mom Power, an evidence-based two generation intervention for mothers with histories of trauma, enhances physiological and behavioral self-regulation in mothers and young children, testing mechanisms and examining bidirectional effects. The central hypothesis is that the intervention will shift behavioral and physiological (Respiratory Sinus Arrhythmia) self-regulation in mothers, children, and dyads to mitigate psychopathology risk. Three specific aims are proposed: 1) Examine intervention effects on children's biobehavioral self-regulation and psychopathology; 2) Examine intervention effects on mothers' biobehavioral self-regulation, psychopathology, and parenting behavior; and 3) Examine intergenerational change processes, including shifts in dyadic physiological and behavioral synchrony as well as bidirectional influences between mother and child self-regulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are two arms: an experimental group receiving the Mom Power group intervention over 10 weeks, and a wait list control group. Treatment delivery will be consistent with the Mom Power manual. The waitlist control group will be offered to participate in the intervention following the trial period.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Mom Power InterventionThe treatment group receives the 10-week, group-based Mom Power intervention; intervention is provided to both mothers and children by trained providers. Treatment delivery will be consistent with the Mom Power manual. |
| Waitlist control | No intervention | –Participants randomized to waitlist control will not receive treatment during the experimental period; they will be offered treatment following completion of post- assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- For moms: Mothers must be female, the biological mother, have an ACE score of 3 or more, speak English, and be 18 years or older.
- For children: Children must be between the ages of 2 and 5.
Key exclusion criteria (2 listed)
- For mothers: No pacemaker or self-reported heart condition; no active maternal substance abuse or psychosis on screeners (Brown \& Rounds, 1995; Degenhardt, Hall, Korten, \& Jablensky, 2005).
- For children: No parent report of diagnosis of autism or global development delay, no parent report of pacemaker or heart condition
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 |
|---|---|---|
| Mom Power InterventionMom Power is a 10-week therapeutic intervention for at-risk families that incorporates elements of several evidence based practices. It combines didactic material with mindbody self-care skills and in vivo practice to improve the quality of attachment between parent and child, and to reduce the psychopathology of at-risk parents. The child team component provides each child with one-on-one care focusing on meeting the child's social-emotional needs and providing attachment-related experiences within a developmental framework. | Behavioural | Treatment |
Primary outcome
Child RSA
Time frame: Within 6 weeks of treatment group completion; approximately 4 months
Child self-regulation will be assessed physiologically with RSA baseline and RSA change during a parent-child dyadic task (Skowron et al., 2013); derived from electrocardiogram (ECG) collected using Mindware Technologies ambulatory mobile recorders during 1) 2-minute resting baseline; 2) a dyadic interaction task. ECG signals will be synchronized at acquisition with video and processed offline using Mindware software; research assistants will visually inspect for missing or erroneously identified R-peaks. Using spectral analysis of interbeat intervals, high-frequency heart rate variability will be extracted to quantify RSA within frequency bandwidths associated with respiration (.15-.40 for mothers; .24-1.04 for children), processed in 1-minute epochs averaged across tasks, and log-transformed.
Parent RSA
Time frame: Within 6 weeks of treatment group completion; approximately 4 months
Parent self-regulation will be assessed physiologically with RSA baseline and RSA change during a parent-child dyadic task (Skowron et al., 2013); derived from electrocardiogram (ECG) collected using Mindware Technologies ambulatory mobile recorders during 1) 2-minute resting baseline; 2) a dyadic interaction task. ECG signals will be synchronized at acquisition with video and processed offline using Mindware software; research assistants will visually inspect for missing or erroneously identified R-peaks. Using spectral analysis of interbeat intervals, high-frequency heart rate variability will be extracted to quantify RSA within frequency bandwidths associated with respiration (.15-.40 for mothers; .24-1.04 for children), processed in 1-minute epochs averaged across tasks, and log-transformed.
12 secondary outcomes
Child Behavior - parent report
Time frame: Within 6 weeks of treatment group completion; approximately 4 months
Child Behavior - teacher report
Time frame: Within 6 weeks of treatment group completion; approximately 4 months
Dyadic synchrony - physiological
Time frame: Within 6 weeks of treatment group completion; approximately 4 months
Dyadic synchrony - observational
Time frame: Within 6 weeks of treatment group completion; approximately 4 months
Parent psychopathology
Time frame: Within 6 weeks of treatment group completion; approximately 4 months
Parent emotion regulation
Time frame: Within 6 weeks of treatment group completion; approximately 4 months
Sensitive parenting behavior
Time frame: Within 6 weeks of treatment group completion; approximately 4 months
Parent self-efficacy
Time frame: Within 6 weeks of treatment group completion; approximately 4 months
Parenting behavior
Time frame: Within 6 weeks of treatment group completion; approximately 4 months
Parent mental representation
Time frame: Within 6 weeks of treatment group completion; approximately 4 months
Child Behavioral Self-Regulation, observational
Time frame: Within 6 weeks of treatment group completion; approximately 4 months
Child Behavioral Self-Regulation, parent report
Time frame: Within 6 weeks of treatment group completion; approximately 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Background: PubMed 28647759Rosenblum KL, Muzik M, Morelen DM, Alfafara EA, Miller NM, Waddell RM, Schuster MM, Ribaudo J. A community-based randomized controlled trial of Mom Power parenting intervention for mothers with interpersonal trauma histories and their young children. Arch Womens Ment Health. 2017 Oct;20(5):673-686. doi: 10.1007/s00737-017-0734-9. Epub 2017 Jun 25.
- Bibliography of Sarah Gray, PhDLink provided by the sponsor.
- 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.
Sarah A Gray, PhD principal investigator
Tulane University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mom Power Intervention in people with Self-regulation and Respiratory Sinus Arrhythmia, run by Tulane University at 2 sites 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 2 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: withdrawn, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Child RSA (time frame: Within 6 weeks of treatment group completion; approximately 4 months). The study lists 2 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 NCT04241913, 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 4 Jun 2021.