Maternal Care PatternsMom-NetRCTNCT01535352
Depressed Mothers in Rural Areas: Web-Facilitated Cognitive Behavioral Treatment
A study testing Mom-Net and Coach-facilitated Treatment as Usual in people with Maternal Care Patterns, run by Oregon Research Institute at 2 sites in United States.
Trial summary
Low income mothers of young children represent a disadvantaged group who are at exceptional risk for depressive syndromes and who have increasingly limited access to mental health services. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Maternal Care Patterns
- What is being tested?
- Mom-Net and Coach-facilitated Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2012to Apr 2017
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Mother of 3-5 year old child(ren)
- Reside in rural community, as defined by RUCA
- Meet DSM IV criteria for major or minor depression based on PHQ-9
Who cannot join
- Cannot comprehend spoken English
- Being treated for depression at intake
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Options Counseling Services of Oregon
Eugene, Oregon, 97401
Oregon Research Institute
Eugene, Oregon, 97403
About this study
Low income mothers of young children represent a disadvantaged group who are at exceptional risk for depressive syndromes and who have increasingly limited access to mental health services. The proposed project is designed to evaluate Mom-Net, an internet-facilitated cognitive-behavioral(CBT) intervention for depression, adapted from Lewinsohn's Coping with Depression Course, and tailored to mothers of young children. Mom-Net, which was developed and piloted in an recently completed NIMH-funded investigation (MH070426), was designed to overcome the substantial barriers to treatment participation that exist for mothers experiencing economic hardship and those in rural communities. Though the pilot trial demonstrated that the program was very effective in reducing depressive symptoms and related difficulties, it was conducted under the 'idealized' conditions typical of initial intervention tests (e.g., computers and internet connections were supplied to all participants; access to the internet was provided by a single browser; coaches who provided weekly phone support were research staff, and initial recruitment and motivational interviews sessions were conducted via home visits to participants). These conditions likely facilitated recruitment and retention of participants, as well as ease and fidelity of treatment delivery. Thus one goal of the current project is to evaluate the intervention under conditions that are closer to those of real-world service providers and recipients. The current project is also intended to provide a more rigorous test of the intervention than did the pilot in a number of ways. Participants in the pilot trial will be 300 mothers of 3-5 year old children recruited through Head Start classrooms and prescreened for the presence of elevated depressive symptoms.Subsequent to the pre-intervention assessment, participants will be randomized to either the intervention or facilitated usual care (FUC) condition. The evaluation of the intervention will focus on maternal depressive symptoms, parenting behavior, and child adjustment. Two follow-up assessments (at 12-month and 24-month intervals) will enable us to examine maintenance of effects. Overall, the investigation will contribute to the evidentiary base regarding the dissemination potential of this empirically-supported intervention, adaptations to which have the potential to enable a greater proportion of the population to access and benefit from it.
Read the detailed description
The project is designed to evaluate Mom-Net, an internet-facilitated cognitive-behavioral (CBT) intervention for depression, adapted from Lewinsohn's Coping with Depression Course, and tailored to mothers of young children. Mom-Net, which was developed and piloted in a recently completed NIMH-funded investigation (MH070426), was designed to overcome the substantial barriers to treatment participation that exist for mothers experiencing economic hardship and those in rural communities. Though the pilot trial demonstrated that the program was very effective in reducing depressive symptoms and related difficulties, it was conducted under the 'idealized' conditions typical of initial intervention tests (e.g., computers and internet connections were supplied to all participants; access to the internet was provided by a single browser; coaches who provided weekly phone support were research staff, and initial recruitment and motivational interviews sessions were conducted via home visits to participants). These conditions likely facilitated recruitment and retention of participants, as well as ease and fidelity of treatment delivery. Thus one goal of the current project is to evaluate the intervention under conditions that are closer to those of real-world service providers and recipients. The current project is also intended to provide a more rigorous test of the intervention than did the pilot in a number of ways. Participants in this project will be 300 mothers of 3-5 year old children recruited through Head Start classrooms and prescreened for the presence of elevated depressive symptoms. Subsequent to the pre-intervention assessment, participants will be randomized to either the intervention or facilitated usual care (FUC) condition. The evaluation of the intervention will focus on maternal depressive symptoms, parenting behavior, and child adjustment. Two follow-up assessments (at 12-month and 24-month intervals) will enable us to examine maintenance of effects. Overall, the investigation will contribute to the evidentiary base regarding the dissemination potential of this empirically-supported intervention, adaptations to which have the potential to enable a greater proportion of the population to access and benefit from it.
- Conditions
- Maternal Care Patterns
- Being tested
- Mom-Net, Coach-facilitated Treatment as Usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mom-NetBehavioural
The Mom-Net intervention is an internet-facilitated cognitive-behavioral intervention for depression, adapted from the CWDC, and tailored to mothers of young children. Mom-Net has several core components: 1. A guided course for self-regulated learning of CBT skills. 2. A system of professional support in which coaches provide weekly 15-20 min phone check-ins (coach calls) in order to encourage and facilitate progress through the intervention and respond rapidly to participant queries and emergencies. In this regard, coaches benefited from: a) a 'behind the scenes" administration page on the website that enabled them to track participants' progress through the intervention and use this information to tailor coaching sessions; and b) an automated system for alerting coaches/supervisors when participants were in crisis. 3. A coach-moderated bulletin board that approximated the social support provided by group administration.
Coach-facilitated Treatment as UsualBehavioural
Participants in the facilitated usual care (FUC) condition will receive assistance in accessing mental health interventions through community providers that serve low-income individuals. In order to control for the supportive attention provided to mothers in the MN condition by the weekly coach calls, mothers in the FUC condition will receive weekly check-in calls from research staff during the intervention period. Participants in both conditions will receive Booster calls during the follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| Internet-facilitated CBT | Experimental | Participants in the randomized trial will be 300 mothers of 3-5 year old children recruited through Head Start (HS) classrooms and screened for the presence of major or minor depression. Subsequent to the pre-intervention assessment, participants will be randomized, with an allocation ratio of 1:1, to either the Mom-Net (MN) intervention or facilitated usual care (FUC) condition. Participants in the MN condition will receive the Mom-Net intervention. The Mom-Net program is an internet-facilitated cognitive-behavioral intervention for depression, adapted from the CWDC, and tailored to mothers of young children. Participants in both conditions will receive Booster calls during the follow-up period. Receives: Behavioral: Mom-Net |
| Coach-facilitated Treatment as Usual | Active comparator | Participants in the FUC condition will receive assistance in accessing mental health interventions through community providers that serve low-income individuals. In order to control for the supportive attention provided to mothers in the MN condition by the weekly coach calls, mothers in the FUC condition will receive weekly check-in calls from research staff during the intervention period. Participants in both conditions will receive Booster calls during the follow-up period. Receives: Behavioral: Coach-facilitated Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
PHQ-9
Severity of depression
Measured: 4 months, 16 months, 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Maternal Care PatternsStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535352
- Sponsor's protocol ID
- R01MH091199-02
- Acronym
- Mom-NetRCT
- Status last verified
- Aug 2019
- First submitted
- 14 Feb 2012
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sheeber LB, Feil EG, Seeley JR, Leve C, Gau JM, Davis B, Sorensen E, Allan S. Mom-net: Evaluation of an internet-facilitated cognitive behavioral intervention for low-income depressed mothers. J Consult Clin Psychol. 2017 Apr;85(4):355-366. doi: 10.1037/ccp0000175.
PubMed 28333536Seeley JR, Sheeber LB, Feil EG, Leve C, Davis B, Sorensen E, Allan S. Mediation analyses of Internet-facilitated cognitive behavioral intervention for maternal depression. Cogn Behav Ther. 2019 Jul;48(4):337-352. doi: 10.1080/16506073.2018.1513554. Epub 2018 Oct 12.
PubMed 30311850
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depressed Mothers in Rural Areas: Web-Facilitated Cognitive Behavioral Treatment
- ClinicalTrials.gov ID
- NCT01535352
- Acronym / sponsor ID
- Mom-NetRCT / R01MH091199-02
- Conditions
- Maternal Care Patterns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 17 Feb 2012 (estimated)
- 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.
Low income mothers of young children represent a disadvantaged group who are at exceptional risk for depressive syndromes and who have increasingly limited access to mental health services. The proposed project is designed to evaluate Mom-Net, an internet-facilitated cognitive-behavioral(CBT) intervention for depression, adapted from Lewinsohn's Coping with Depression Course, and tailored to mothers of young children. Mom-Net, which was developed and piloted in an recently completed NIMH-funded investigation (MH070426), was designed to overcome the substantial barriers to treatment participation that exist for mothers experiencing economic hardship and those in rural communities. Though the pilot trial demonstrated that the program was very effective in reducing depressive symptoms and related difficulties, it was conducted under the 'idealized' conditions typical of initial intervention tests (e.g., computers and internet connections were supplied to all participants; access to the internet was provided by a single browser; coaches who provided weekly phone support were research staff, and initial recruitment and motivational interviews sessions were conducted via home visits to participants). These conditions likely facilitated recruitment and retention of participants, as well as ease and fidelity of treatment delivery. Thus one goal of the current project is to evaluate the intervention under conditions that are closer to those of real-world service providers and recipients. The current project is also intended to provide a more rigorous test of the intervention than did the pilot in a number of ways. Participants in the pilot trial will be 300 mothers of 3-5 year old children recruited through Head Start classrooms and prescreened for the presence of elevated depressive symptoms.Subsequent to the pre-intervention assessment, participants will be randomized to either the intervention or facilitated usual care (FUC) condition. The evaluation of the intervention will focus on maternal depressive symptoms, parenting behavior, and child adjustment. Two follow-up assessments (at 12-month and 24-month intervals) will enable us to examine maintenance of effects. Overall, the investigation will contribute to the evidentiary base regarding the dissemination potential of this empirically-supported intervention, adaptations to which have the potential to enable a greater proportion of the population to access and benefit from it.
Detailed description
The project is designed to evaluate Mom-Net, an internet-facilitated cognitive-behavioral (CBT) intervention for depression, adapted from Lewinsohn's Coping with Depression Course, and tailored to mothers of young children. Mom-Net, which was developed and piloted in a recently completed NIMH-funded investigation (MH070426), was designed to overcome the substantial barriers to treatment participation that exist for mothers experiencing economic hardship and those in rural communities. Though the pilot trial demonstrated that the program was very effective in reducing depressive symptoms and related difficulties, it was conducted under the 'idealized' conditions typical of initial intervention tests (e.g., computers and internet connections were supplied to all participants; access to the internet was provided by a single browser; coaches who provided weekly phone support were research staff, and initial recruitment and motivational interviews sessions were conducted via home visits to participants). These conditions likely facilitated recruitment and retention of participants, as well as ease and fidelity of treatment delivery. Thus one goal of the current project is to evaluate the intervention under conditions that are closer to those of real-world service providers and recipients. The current project is also intended to provide a more rigorous test of the intervention than did the pilot in a number of ways. Participants in this project will be 300 mothers of 3-5 year old children recruited through Head Start classrooms and prescreened for the presence of elevated depressive symptoms. Subsequent to the pre-intervention assessment, participants will be randomized to either the intervention or facilitated usual care (FUC) condition. The evaluation of the intervention will focus on maternal depressive symptoms, parenting behavior, and child adjustment. Two follow-up assessments (at 12-month and 24-month intervals) will enable us to examine maintenance of effects. Overall, the investigation will contribute to the evidentiary base regarding the dissemination potential of this empirically-supported intervention, adaptations to which have the potential to enable a greater proportion of the population to access and benefit from it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-facilitated CBT | Experimental | Behavioral: Mom-NetParticipants in the randomized trial will be 300 mothers of 3-5 year old children recruited through Head Start (HS) classrooms and screened for the presence of major or minor depression. Subsequent to the pre-intervention assessment, participants will be randomized, with an allocation ratio of 1:1, to either the Mom-Net (MN) intervention or facilitated usual care (FUC) condition. Participants in the MN condition will receive the Mom-Net intervention. The Mom-Net program is an internet-facilitated cognitive-behavioral intervention for depression, adapted from the CWDC, and tailored to mothers of young children. Participants in both conditions will receive Booster calls during the follow-up period. |
| Coach-facilitated Treatment as Usual | Active comparator | Behavioral: Coach-facilitated Treatment as UsualParticipants in the FUC condition will receive assistance in accessing mental health interventions through community providers that serve low-income individuals. In order to control for the supportive attention provided to mothers in the MN condition by the weekly coach calls, mothers in the FUC condition will receive weekly check-in calls from research staff during the intervention period. Participants in both conditions will receive Booster calls during the follow-up period. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Mother of 3-5 year old child(ren)
- Reside in rural community, as defined by RUCA
- Meet DSM IV criteria for major or minor depression based on PHQ-9
Key exclusion criteria (2 listed)
- Cannot comprehend spoken English
- Being treated for depression at intake
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-NetThe Mom-Net intervention is an internet-facilitated cognitive-behavioral intervention for depression, adapted from the CWDC, and tailored to mothers of young children. Mom-Net has several core components: 1. A guided course for self-regulated learning of CBT skills. 2. A system of professional support in which coaches provide weekly 15-20 min phone check-ins (coach calls) in order to encourage and facilitate progress through the intervention and respond rapidly to participant queries and emergencies. In this regard, coaches benefited from: a) a 'behind the scenes" administration page on the website that enabled them to track participants' progress through the intervention and use this information to tailor coaching sessions; and b) an automated system for alerting coaches/supervisors when participants were in crisis. 3. A coach-moderated bulletin board that approximated the social support provided by group administration. | Behavioural | Internet-facilitated CBT |
| Coach-facilitated Treatment as UsualParticipants in the facilitated usual care (FUC) condition will receive assistance in accessing mental health interventions through community providers that serve low-income individuals. In order to control for the supportive attention provided to mothers in the MN condition by the weekly coach calls, mothers in the FUC condition will receive weekly check-in calls from research staff during the intervention period. Participants in both conditions will receive Booster calls during the follow-up period. | Behavioural | Coach-facilitated Treatment as Usual |
Primary outcome
PHQ-9
Time frame: 4 months, 16 months, 28 months
Severity of depression
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 28 Aug 2019.
- Results publication: PubMed 28333536Sheeber LB, Feil EG, Seeley JR, Leve C, Gau JM, Davis B, Sorensen E, Allan S. Mom-net: Evaluation of an internet-facilitated cognitive behavioral intervention for low-income depressed mothers. J Consult Clin Psychol. 2017 Apr;85(4):355-366. doi: 10.1037/ccp0000175.
- Results publication: PubMed 30311850Seeley JR, Sheeber LB, Feil EG, Leve C, Davis B, Sorensen E, Allan S. Mediation analyses of Internet-facilitated cognitive behavioral intervention for maternal depression. Cogn Behav Ther. 2019 Jul;48(4):337-352. doi: 10.1080/16506073.2018.1513554. Epub 2018 Oct 12.
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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.
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-Net and Coach-facilitated Treatment as Usual in people with Maternal Care Patterns, run by Oregon Research Institute 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 3 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: finished, as of the sponsor's last update on 28 Aug 2019. 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 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?
PHQ-9 (time frame: 4 months, 16 months, 28 months). 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 NCT01535352, which also lists 2 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 28 Aug 2019.