PsychopathologyNCT05129397
Virtual Mom Power With High-Adversity Mothers and Children (MPHAMC)
A study testing Mom Power and Mom Power Informational Mailing in people with Psychopathology, run by Tulane University at 1 site in United States.
Trial summary
This study is a randomized controlled confirmatory efficacy trial of virtual Mom Power (MP), a group-based, relationship-focused multifamily preventive intervention. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychopathology
- What is being tested?
- Mom Power and Mom Power Informational Mailing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 30 Jan 2024
- 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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Enrollment status in one of the following services: Supplemental Nutrition Assistance Program (SNAP), Family Independence Temporary Assistance Program (FITAP), Medicaid, Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), or Head Start
- Maternal age of at least 18 years
- Mother is primary caregiver of child
- Mother speaks English
- Child age is between 3-5 years
- Family resides within 8 parish New Orleans metro area
Who cannot join
- Mother is not biological mother
- Diagnosis of a heart condition in the mother or the child
- Presence of a pacemaker in the mother or the child
- Child diagnosis of autism or global developmental delay
- Active maternal substance use
- Active maternal psychosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Tulane Child and Family Lab
New Orleans, Louisiana, 70118
About this study
Official title: A Randomized Controlled Trial to Improve Biobehavioral Regulation Among High-Adversity Mothers and Young Children
This study is a randomized controlled confirmatory efficacy trial of virtual Mom Power (MP), a group-based, relationship-focused multifamily preventive intervention.
Read the detailed description
This study is a randomized controlled confirmatory efficacy trial of virtual Mom Power (MP), a group-based, relationship-focused multifamily intervention with previously demonstrated effectiveness improving maternal mental health and parenting stress in randomized controlled trials. vMP targets 5 core components: 1) enhancing social support; 2) attachment-based parenting education; 3) self-care, including affect regulation; 4) guided parent-child interactions, and 5) connecting to care. Eligible and enrolled participants will be randomized to receive the 10 week group-based intervention or 10 weeks of informational mailings; both groups will receive individual home-based sessions. Outcomes include maternal social support, psychopathology, sensitive parenting, child psychopathology, two-generational biobehavioral self-regulation targets (Respiratory Sinus Arrhythmia), parent and child emotion and behavior regulation, and dyadic behavioral and physiological synchrony. Assessments will occur at intake, post, and 6 months following the group.
- Conditions
- Psychopathology
- Being tested
- Mom Power, Mom Power Informational Mailing
- Keywords
- biobehavioral regulation, Respiratory Sinus Arrhythmia, parenting behavior
- Medical subject headings
- Arrhythmia, Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mom PowerBehavioural
Virtual Mom Power is a manualized multi-family group intervention consisting of 10 virtual group + 2 individual sessions led by two masters-level co-facilitators. Virtual groups are 90 minutes, following a structured format via secure HIPAA compatible video platform. The curriculum includes 5 core components: (1) Attachment-Focused Parenting Education; (2) Self-Care; (3) Parenting Practice (4) Social Support; \& (5) Connection to Resources. Individual sessions combine motivational interviewing with MP core components and focus on identifying goals and barriers. Weekly between-group phone/text check-ins are also a part of the curriculum, used to strengthen connection, build trust, ensure safety, and assess basic needs.
Mom Power Informational MailingBehavioural
This active comparison condition intervention includes two individual sessions along with 10 weeks of informational mailing with content related to Mom Power core concepts.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The experimental arm of Virtual Mom Power is a manualized multi-family group intervention consisting of 10, 90-minute virtual group + 2 individual sessions led by two co-facilitators. The curriculum includes 5 core components: (1) Attachment-Focused Parenting Education; (2) Self-Care; (3) Parenting Practice; (4) Social Support; \& (5) Connection to Resources. Individual sessions combine motivational interviewing with MP core components and focus on identifying goals and barriers. We will work with mothers in individual coaching to problem-solve childcare and privacy during group time. Weekly between-group phone/text check-ins are also a part of the curriculum, used to strengthen connection, build trust, ensure safety, and assess basic needs. Data regarding attendance will be recorded and total dosage examined in treatment effects. Receives: Behavioral: Mom Power |
| Informational control | Active comparator | The control arm of this study consists of two individual sessions with mothers, along with 10 weeks of virtual informational mailings. The mailings will contain Mom Power curriculum about attachment-based parenting and self-care. The individual sessions will focus on individual goal-setting related to parenting and reflection on the parent-child relationship. The control group does not include the components of social support, affect regulation skills coaching, or guided parent-child interaction that are part of the experimental arm. Receives: Behavioral: Mom Power Informational Mailing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline maternal depressive symptoms at post-intervention
Mothers will report on their own depressive symptoms using the Patient Health Questionnaire-9 (PHQ-9) at baseline, post-intervention, and 6 month follow up; change in sum scale from baseline at post-intervention will be assessed. Higher scores reflect more depressive symptoms.
Measured: At completion of intervention, approximately 3 months
Change from baseline maternal depressive symptoms at 6 month follow up
Mothers will report on their own depressive symptoms using the Patient Health Questionnaire-9 (PHQ-9) at baseline, post-intervention, and 6 month follow up; change in sum scale from baseline to 6 month follow up will be assessed. Higher scores reflect more depressive symptoms.
Measured: 6 months (follow up)
Change from baseline maternal posttraumatic stress symptoms at post-intervention
Mothers will report on their own posttraumatic stress symptoms using the Posttraumatic Checklist for Diagnostic and Statistical Manual Diploma in Social Medicine-5 (PCL-5). Sum scales will be assessed at baseline, post-intervention (3 months), and 6 month follow up; change in sum scale from baseline to 3 month follow up will be assessed. Higher scores reflect more posttraumatic stress symptoms.
Measured: At completion of intervention, approximately 3 months
Change from baseline maternal posttraumatic stress symptoms at 6 month follow up
Mothers will report on their own posttraumatic stress symptoms using the Posttraumatic Checklist for Diagnostic and Statistical Manual Diploma in Social Medicine-5 (PCL-5). Sum scales will be assessed at baseline, post-intervention (3 months), and 6 month follow up; change in sum scale from baseline to 6 month follow up will be assessed. Higher scores reflect more posttraumatic stress symptoms.
Measured: 6 months (follow up)
Change from baseline child behavior at post-intervention
Mothers will report on child behavior on the Child Behavior Checklist (CBCL 1.5-5). Sum scores will be used. Higher scores reflect more behavior problems.
Measured: At completion of intervention, approximately 3 months
Change from baseline child behavior at 6 month follow up.
Mothers will report on child behavior on the Child Behavior Checklist (CBCL 1.5-5). Sum scores will be used. Higher scores reflect more behavior problems.
Measured: 6 months (follow up)
Secondary outcomes (16)
Change in parenting stress from baseline to post-intervention
Mothers will report on their own parenting stress using the Parenting Stress Index - 4, Short Form (PSI-SF); change in the the Total Stress scale from baseline to post-assessment (3 months) will be examined. Higher scores reflect more parenting stress.
Measured: At completion of intervention, approximately 3 months
Change in parenting stress from baseline to 6 month follow up
Mothers will report on their own parenting stress using the Parenting Stress Index - 4, Short Form (PSI-SF); change in the the Total Stress scale from baseline to follow up (6 months) will be examined. Higher scores reflect more parenting stress.
Measured: 6 months
Change in self-report parent child relationship from baseline to post intervention
Mothers will report on their own parenting stress using the Parenting Stress Index - 4, Short Form (PSI-SF); change in the the Parent Child Dysfunctional Interaction scale from baseline to post-assessment (3 months) will be examined. Higher scores reflect more dysfunction.
Measured: At completion of intervention, approximately 3 months
Change in self-report parent child relationship from baseline to follow up
Mothers will report on their own parenting stress using the Parenting Stress Index - 4, Short Form (PSI-SF); change in the the Parent Child Dysfunctional Interaction scale from baseline to follow up (6 months) will be examined. Higher scores reflect more dysfunction.
Measured: 6 months
Change in maternal social support from baseline to post intervention
Mothers will report on their perceived social support a using the Multidimensional Scale of Perceived Social Support (MSPSS). Change from baseline to post intervention (3 months) will be examined. Higher scores reflect more social support.
Measured: At completion of intervention, approximately 3 months
Change in maternal social support from baseline to follow up
Mothers will report on their perceived social support a using the Multidimensional Scale of Perceived Social Support (MSPSS). Change from baseline to follow up (6 months) will be examined. Higher scores reflect more social support.
Measured: 6 months
Change in observed parenting sensitivity from baseline to post-intervention
Parenting sensitivity will be assessed at baseline and post intervention (3 months) with an observational measure. Video tapes of parent-child interactions during a 5-minute period of free play and a 5-minute period of structured interaction with a challenging puzzle will be coded using the Coding Interactive Behavior (CIB) measure. Parenting sensitivity scales will be used. Higher scores reflect more sensitivity.
Measured: At completion of intervention, approximately 3 months
Change in Working Models from baseline to post-intervention
Mothers and evaluators will complete a Working Model of the Child Interview (WMCI) at baseline and post-intervention (3 months) to assess parents' internal working model classifications. Classifications as Balanced, Disengaged, and Distorted will be used. Classification as balance is considered a more adaptive outcome.
Measured: At completion of intervention, approximately 3 months
Change in maternal emotion regulation from baseline to post-intervention
Mothers will report on their difficulties in emotion regulation (Difficulties in Emotion Regulation Scale). Change in the sum score from baseline to post-intervention will be examined. Higher scores reflect more difficulties in emotion regulation.
Measured: At completion of intervention, approximately 3 months
Change in maternal emotion regulation from baseline to follow up
Mothers will report on their difficulties in emotion regulation (Difficulties in Emotion Regulation Scale). Change in the sum score from baseline to 6 month follow up will be examined. Higher scores reflect more difficulties in emotion regulation.
Measured: 6 months
Change in maternal emotion regulation while parenting from baseline to post intervention
Mothers will report on their parenting-specific behavioral self-regulation (Regulating Emotions in Parenthood). Change in the sum score from baseline to post intervention will be examined.
Measured: At completion of intervention, approximately 3 months
Change in maternal emotion regulation while parenting from baseline to follow up
Mothers will report on their parenting-specific behavioral self-regulation (Regulating Emotions in Parenthood). Change in the sum score from baseline to 6 month follow up will be examined.
Measured: 6 months
Change in maternal resting Respiratory Sinus Arrhythmia from baseline to post-intervention
At baseline assessments and at post-intervention assessments, electrocardiogram data will be collected during a 2 minute neutral video tsak. 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 respiratory sinus arrhythmia (RSA) within frequency bandwidths associated with respiration (.15-.40 for mothers) and log-transformed. Change in resting RSA from baseline to post-intervention will be examined. Higher resting RSA is expected post-intervention.
Measured: At completion of intervention, approximately 3 months
Change in maternal Respiratory Sinus Arrhythmia reactivity from baseline to post-intervention
Electrocardiogram data will be collected during a 2 minute baseline neutral video task and a 5 minute parent-child puzzle teaching 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 (24-1.04 for children) and log-transformed. Respiratory Sinus Arrhythmia reactivity in response to the puzzle task will be assessed at baseline and post-intervention (3 months)
Measured: At completion of intervention, approximately 3 months
Change in child resting Respiratory Sinus Arrhythmia from baseline to post-intervention
Electrocardiogram data will be collected during a 2 minute baseline neutral video 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 (24-1.04 for children) and log-transformed. Change in children's resting Respiratory Sinus Arrhythmia during the neutral task will be assessed from baseline to post-intervention (3 months). Higher resting RSA is expected post-intervention.
Measured: At completion of intervention, approximately 3 months
Change in child Respiratory Sinus Arrhythmia reactivity from baseline to post-intervention
Electrocardiogram data will be collected during a 2 minute baseline neutral video task and a 5 minute parent-child puzzle teaching 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 (24-1.04 for children) and log-transformed. Change in children's Respiratory Sinus Arrhythmia reactivity during the puzzle task from baseline to post-intervention will be assessed.
Measured: At completion of intervention, approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start1 Nov 2021
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for PsychopathologyStudies 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 control group that will receive informational virtual mailings over 10 weeks. Treatment delivery will be consistent with the Mom Power manual and informational mailings will contain content from the Mom Power Curriculum.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- NCT05129397
- Sponsor's protocol ID
- 2018-2012-TU Uptown
- Other IDs
- K23MH119047
- Status last verified
- Aug 2024
- First submitted
- 25 Oct 2021
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lowe B, Unutzer J, Callahan CM, Perkins AJ, Kroenke K. Monitoring depression treatment outcomes with the patient health questionnaire-9. Med Care. 2004 Dec;42(12):1194-201. doi: 10.1097/00005650-200412000-00006.
PubMed 15550799Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.
PubMed 26606250Achenbach, T. M., & Rescorla, L. A. (2000). Manual for the ASEBA preschool forms & profiles: An integrated system of multi-informant assessment. University of Vermont.
Abidin, Richard R. Parenting stress index-short form. Charlottesville, VA: Pediatric psychology press, 1990.
Zimet, G. D., Dahlem, N. W., Zimet, S. G., & Farely, G. K. (1988). The Multidimensional Scale of perceived Social Support. Journal of Personality Assessment, 52(1), 30-41.
Feldman R, Granat A, Pariente C, Kanety H, Kuint J, Gilboa-Schechtman E. Maternal depression and anxiety across the postpartum year and infant social engagement, fear regulation, and stress reactivity. J Am Acad Child Adolesc Psychiatry. 2009 Sep;48(9):919-927. doi: 10.1097/CHI.0b013e3181b21651.
PubMed 19625979Zeanah, C. H. (2007). Constructing a relationship formulation for mother and child: Clinical application of the Working Model of the Child Interview. In D. Oppenheim & D. F. Goldsmith (Eds.), Attachment Theory in Clinical Work with Children: Bridging the Gap Between Research and Practice (pp. 3-30). New York, NY: Guilford Press.
Gratz, K. L., & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of Psychopathology and Behavioral Assessment, 26(1), 41-54
Rodriguez VJ, Shaffer A. Validation of the Regulating Emotions in Parenting Scale (REPS): Factor structure and measurement invariance. J Fam Psychol. 2021 Jun;35(4):468-477. doi: 10.1037/fam0000808. Epub 2020 Sep 17.
PubMed 32940490Conduct Problems Prevention Research Group. Initial impact of the Fast Track prevention trial for conduct problems: I. The high-risk sample. Conduct Problems Prevention Research Group. J Consult Clin Psychol. 1999 Oct;67(5):631-47.
PubMed 10535230Smith-Donald, R., Raver, C. C., Hayes, T., & Richardson, B. (2007). Preliminary construct and concurrent validity of the Preschool Self-regulation Assessment (PSRA) for field-based research. Early Childhood Research Quarterly, 22(2), 173-187
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 28647759Rosenblum K, Lawler J, Alfafara E, Miller N, Schuster M, Muzik M. Improving Maternal Representations in High-Risk Mothers: A Randomized, Controlled Trial of the Mom Power Parenting Intervention. Child Psychiatry Hum Dev. 2018 Jun;49(3):372-384. doi: 10.1007/s10578-017-0757-5.
PubMed 28936602
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. 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
- NCT05129397
- Acronym / sponsor ID
- 2018-2012-TU Uptown
- Conditions
- Psychopathology
- Keywords
- biobehavioral regulation, Respiratory Sinus Arrhythmia, parenting behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 22 Nov 2021 (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 is a randomized controlled confirmatory efficacy trial of virtual Mom Power (MP), a group-based, relationship-focused multifamily preventive intervention.
Detailed description
This study is a randomized controlled confirmatory efficacy trial of virtual Mom Power (MP), a group-based, relationship-focused multifamily intervention with previously demonstrated effectiveness improving maternal mental health and parenting stress in randomized controlled trials. vMP targets 5 core components: 1) enhancing social support; 2) attachment-based parenting education; 3) self-care, including affect regulation; 4) guided parent-child interactions, and 5) connecting to care. Eligible and enrolled participants will be randomized to receive the 10 week group-based intervention or 10 weeks of informational mailings; both groups will receive individual home-based sessions. Outcomes include maternal social support, psychopathology, sensitive parenting, child psychopathology, two-generational biobehavioral self-regulation targets (Respiratory Sinus Arrhythmia), parent and child emotion and behavior regulation, and dyadic behavioral and physiological synchrony. Assessments will occur at intake, post, and 6 months following the group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There are two arms: an experimental group receiving the Mom Power group intervention over 10 weeks, and a control group that will receive informational virtual mailings over 10 weeks. Treatment delivery will be consistent with the Mom Power manual and informational mailings will contain content from the Mom Power Curriculum.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Mom PowerThe experimental arm of Virtual Mom Power is a manualized multi-family group intervention consisting of 10, 90-minute virtual group + 2 individual sessions led by two co-facilitators. The curriculum includes 5 core components: (1) Attachment-Focused Parenting Education; (2) Self-Care; (3) Parenting Practice; (4) Social Support; \& (5) Connection to Resources. Individual sessions combine motivational interviewing with MP core components and focus on identifying goals and barriers. We will work with mothers in individual coaching to problem-solve childcare and privacy during group time. Weekly between-group phone/text check-ins are also a part of the curriculum, used to strengthen connection, build trust, ensure safety, and assess basic needs. Data regarding attendance will be recorded and total dosage examined in treatment effects. |
| Informational control | Active comparator | Behavioral: Mom Power Informational MailingThe control arm of this study consists of two individual sessions with mothers, along with 10 weeks of virtual informational mailings. The mailings will contain Mom Power curriculum about attachment-based parenting and self-care. The individual sessions will focus on individual goal-setting related to parenting and reflection on the parent-child relationship. The control group does not include the components of social support, affect regulation skills coaching, or guided parent-child interaction that are part of the experimental arm. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Enrollment status in one of the following services: Supplemental Nutrition Assistance Program (SNAP), Family Independence Temporary Assistance Program (FITAP), Medicaid, Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), or Head Start
- Maternal age of at least 18 years
- Mother is primary caregiver of child
- Mother speaks English
- Child age is between 3-5 years
Key exclusion criteria (6 listed)
- Mother is not biological mother
- Diagnosis of a heart condition in the mother or the child
- Presence of a pacemaker in the mother or the child
- Child diagnosis of autism or global developmental delay
- Active maternal substance use
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 PowerVirtual Mom Power is a manualized multi-family group intervention consisting of 10 virtual group + 2 individual sessions led by two masters-level co-facilitators. Virtual groups are 90 minutes, following a structured format via secure HIPAA compatible video platform. The curriculum includes 5 core components: (1) Attachment-Focused Parenting Education; (2) Self-Care; (3) Parenting Practice (4) Social Support; \& (5) Connection to Resources. Individual sessions combine motivational interviewing with MP core components and focus on identifying goals and barriers. Weekly between-group phone/text check-ins are also a part of the curriculum, used to strengthen connection, build trust, ensure safety, and assess basic needs. | Behavioural | Treatment |
| Mom Power Informational MailingThis active comparison condition intervention includes two individual sessions along with 10 weeks of informational mailing with content related to Mom Power core concepts. | Behavioural | Informational control |
Primary outcome
Change from baseline maternal depressive symptoms at post-intervention
Time frame: At completion of intervention, approximately 3 months
Mothers will report on their own depressive symptoms using the Patient Health Questionnaire-9 (PHQ-9) at baseline, post-intervention, and 6 month follow up; change in sum scale from baseline at post-intervention will be assessed. Higher scores reflect more depressive symptoms.
Change from baseline maternal depressive symptoms at 6 month follow up
Time frame: 6 months (follow up)
Mothers will report on their own depressive symptoms using the Patient Health Questionnaire-9 (PHQ-9) at baseline, post-intervention, and 6 month follow up; change in sum scale from baseline to 6 month follow up will be assessed. Higher scores reflect more depressive symptoms.
Change from baseline maternal posttraumatic stress symptoms at post-intervention
Time frame: At completion of intervention, approximately 3 months
Mothers will report on their own posttraumatic stress symptoms using the Posttraumatic Checklist for Diagnostic and Statistical Manual Diploma in Social Medicine-5 (PCL-5). Sum scales will be assessed at baseline, post-intervention (3 months), and 6 month follow up; change in sum scale from baseline to 3 month follow up will be assessed. Higher scores reflect more posttraumatic stress symptoms.
Change from baseline maternal posttraumatic stress symptoms at 6 month follow up
Time frame: 6 months (follow up)
Mothers will report on their own posttraumatic stress symptoms using the Posttraumatic Checklist for Diagnostic and Statistical Manual Diploma in Social Medicine-5 (PCL-5). Sum scales will be assessed at baseline, post-intervention (3 months), and 6 month follow up; change in sum scale from baseline to 6 month follow up will be assessed. Higher scores reflect more posttraumatic stress symptoms.
Change from baseline child behavior at post-intervention
Time frame: At completion of intervention, approximately 3 months
Mothers will report on child behavior on the Child Behavior Checklist (CBCL 1.5-5). Sum scores will be used. Higher scores reflect more behavior problems.
Change from baseline child behavior at 6 month follow up.
Time frame: 6 months (follow up)
Mothers will report on child behavior on the Child Behavior Checklist (CBCL 1.5-5). Sum scores will be used. Higher scores reflect more behavior problems.
16 secondary outcomes
Change in parenting stress from baseline to post-intervention
Time frame: At completion of intervention, approximately 3 months
Change in parenting stress from baseline to 6 month follow up
Time frame: 6 months
Change in self-report parent child relationship from baseline to post intervention
Time frame: At completion of intervention, approximately 3 months
Change in self-report parent child relationship from baseline to follow up
Time frame: 6 months
Change in maternal social support from baseline to post intervention
Time frame: At completion of intervention, approximately 3 months
Change in maternal social support from baseline to follow up
Time frame: 6 months
Change in observed parenting sensitivity from baseline to post-intervention
Time frame: At completion of intervention, approximately 3 months
Change in Working Models from baseline to post-intervention
Time frame: At completion of intervention, approximately 3 months
Change in maternal emotion regulation from baseline to post-intervention
Time frame: At completion of intervention, approximately 3 months
Change in maternal emotion regulation from baseline to follow up
Time frame: 6 months
Change in maternal emotion regulation while parenting from baseline to post intervention
Time frame: At completion of intervention, approximately 3 months
Change in maternal emotion regulation while parenting from baseline to follow up
Time frame: 6 months
Change in maternal resting Respiratory Sinus Arrhythmia from baseline to post-intervention
Time frame: At completion of intervention, approximately 3 months
Change in maternal Respiratory Sinus Arrhythmia reactivity from baseline to post-intervention
Time frame: At completion of intervention, approximately 3 months
Change in child resting Respiratory Sinus Arrhythmia from baseline to post-intervention
Time frame: At completion of intervention, approximately 3 months
Change in child Respiratory Sinus Arrhythmia reactivity from baseline to post-intervention
Time frame: At completion of intervention, approximately 3 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 7 Aug 2024.
- Background: PubMed 15550799Lowe B, Unutzer J, Callahan CM, Perkins AJ, Kroenke K. Monitoring depression treatment outcomes with the patient health questionnaire-9. Med Care. 2004 Dec;42(12):1194-201. doi: 10.1097/00005650-200412000-00006.
- Background: PubMed 26606250Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.
- BackgroundAchenbach, T. M., & Rescorla, L. A. (2000). Manual for the ASEBA preschool forms & profiles: An integrated system of multi-informant assessment. University of Vermont.
- BackgroundAbidin, Richard R. Parenting stress index-short form. Charlottesville, VA: Pediatric psychology press, 1990.
- BackgroundZimet, G. D., Dahlem, N. W., Zimet, S. G., & Farely, G. K. (1988). The Multidimensional Scale of perceived Social Support. Journal of Personality Assessment, 52(1), 30-41.
- Background: PubMed 19625979Feldman R, Granat A, Pariente C, Kanety H, Kuint J, Gilboa-Schechtman E. Maternal depression and anxiety across the postpartum year and infant social engagement, fear regulation, and stress reactivity. J Am Acad Child Adolesc Psychiatry. 2009 Sep;48(9):919-927. doi: 10.1097/CHI.0b013e3181b21651.
- BackgroundZeanah, C. H. (2007). Constructing a relationship formulation for mother and child: Clinical application of the Working Model of the Child Interview. In D. Oppenheim & D. F. Goldsmith (Eds.), Attachment Theory in Clinical Work with Children: Bridging the Gap Between Research and Practice (pp. 3-30). New York, NY: Guilford Press.
- BackgroundGratz, K. L., & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of Psychopathology and Behavioral Assessment, 26(1), 41-54
- Background: PubMed 32940490Rodriguez VJ, Shaffer A. Validation of the Regulating Emotions in Parenting Scale (REPS): Factor structure and measurement invariance. J Fam Psychol. 2021 Jun;35(4):468-477. doi: 10.1037/fam0000808. Epub 2020 Sep 17.
- Background: PubMed 10535230Conduct Problems Prevention Research Group. Initial impact of the Fast Track prevention trial for conduct problems: I. The high-risk sample. Conduct Problems Prevention Research Group. J Consult Clin Psychol. 1999 Oct;67(5):631-47.
- BackgroundSmith-Donald, R., Raver, C. C., Hayes, T., & Richardson, B. (2007). Preliminary construct and concurrent validity of the Preschool Self-regulation Assessment (PSRA) for field-based research. Early Childhood Research Quarterly, 22(2), 173-187
- 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.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mom Power and Mom Power Informational Mailing in people with Psychopathology, run by Tulane University 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 6 inclusion and 6 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 7 Aug 2024. 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?
Change from baseline maternal depressive symptoms at post-intervention (time frame: At completion of intervention, approximately 3 months). The study lists 6 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 NCT05129397, which also lists 13 linked publications.
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 7 Aug 2024.