DepressionNCT05142384
ICBT (Internet Based Cognitive Behavioral Therapy) for Maternal Depression: Community Implementation in Head Start
A study testing Mom-Net and Treatment as Usual/Waitlist in people with Depression, run by Oregon Research Institute at 1 site in United States.
Trial summary
Low income women of childbearing age are at increased risk for depression and often do not receive needed treatment. Investigators developed Mom-Net, an on-line cognitive behavioral treatment (CBT) for depression to address the needs of low income women of childbearing age. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Mom-Net and Treatment as Usual/Waitlist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 960 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Elevated symptoms of depression (i.e., Patient Health Questionnaire or Edinburgh Postnatal Depression Scale score at or above 10)
- Have a child 2-5 years enrolled in a participating Head Start; be able to communicate in English or Spanish.
- 2-5 years of age and enrolled in participation Head Start
Who cannot join
- Evidence of psychosis or other major mental illness or cognitive disability (observed during recruitment or by HS report) that would interfere with meaningful participation
- Endorsed score of 3 on final item of the PHQ9 or EPDS indicating frequent thoughts of suicide. Could be enrolled at later date if elevated risk ameliorates
- No exclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oregon Research Institute
Springfield, Oregon, 97477
Edward G Feil, Ph.D., 541-484-2123, edf@ori.org
Kendra E Guinness, Ph.D., 541-484-2123, kguinness@ori.org
About this study
Official title: ICBT for Maternal Depression: Community Implementation in Head Start
Low income women of childbearing age are at increased risk for depression and often do not receive needed treatment. Investigators developed Mom-Net, an on-line cognitive behavioral treatment (CBT) for depression to address the needs of low income women of childbearing age. The intervention program also includes live coaching to help the mothers engage and learn the CBT material. Mom-Net has been shown to be highly effective in reducing depressive symptoms and improving parenting behavior and child adjustment, in earlier controlled trials. In this project the investigators are examining whether access to Mom-Net can be expanded by delivering it in Head Starts (HS).
To address that broad question, the investigators will focus on two sets of scientific questions:
Read more
- Implementation Questions: e.g., Can HS agencies deliver the program successfully; do HSs choose to sustain the program after the research project ends; what agency characteristics are associated with successful delivery of Mom-Net);
- Effectiveness Questions: e.g., Does Mom-Net reduce maternal depression when delivered by Head Start agencies, with HS staff doing the coaching?
Head Start agencies will be randomized to deliver either Mom-Net with the usual high-intensity coaching or with a low-intensity coaching alternative. Within each agency, depressed mothers will be randomized to receive either: 1) Mom-Net program; or 2) Treatment as Usual (TAU;) referral to community mental health providers). Mothers initially assigned to the TAU condition, will have the option of receiving Mom-Net at a later date. Mothers will participate in assessments of depressive symptoms, parenting behavior, and child adjustment at Time 1 (T1; prior to randomization); and Time 2 (T2; after the intervention period) and Time 3 (T3; one year after T1).
Read the detailed description
Background:
Low income women of childbearing age are at disproportionate risk for depressive syndromes and, despite the availability of efficacious interventions, often do not receive needed treatment. The investigators developed Mom-Net, a remote, coach-facilitated, Internet-based intervention adapted from an empirically-supported cognitive behavioral treatment (CBT) for depression to address the needs of depressed mothers. Two randomized control trials demonstrated Mom-Net to be highly effective in reducing depressive symptoms and improving parenting behavior and child adjustment. In this project investigators seek to examine whether the reach of the Mom-Net intervention can be expanded by implementing within the Head Start Environment.
Investigators are using a hybrid type 2, Effectiveness-Implementation design to compare two implementation approaches for the delivery of Mom-Net, one with its existing high-intensity coaching approach, and one making use of a low-intensity coaching, designed to provide supportive accountability, but not psychoeducational support. Investigators will follow the Exploration, Preparation, Implementation, and Sustainment process model (EPIS) to guide the evaluation, with the Clinical Trial component primarily constituting the Implementation phase.
Clinical Trial Aims:
- Examine effectiveness and Implementation outcomes of Mom-Net within Head-Start, randomizing agencies to implementation approach (i.e., high- vs low-intensity coaching) and mothers within agency, to either Mom-Net or Treatment as Usual (TAU)/waitlist conditions.
- Compare the two Mom-Net implementation approaches on: 1) implementation outcomes including reach, acceptability, fidelity, and cost; and 2) effectiveness outcomes including self-reported maternal depressive symptoms (primary outcome), parenting behavior, and child emotional and behavioral functioning (secondary outcomes).
- Examine the effectiveness of each Mom-Net implementation approach relative to TAU on the primary and secondary outcomes listed above.
- Consistent with an experimental therapeutic approach, investigators will examine the mediating influence of changes in maternal functioning associated with core Mom-Net skills on maternal depressive symptoms. Mediators to be examined include behavior activation, negative cognitive styles, social support, and belief that mood can be regulated. Investigators will also examine the mediating influence of change in maternal depressive symptoms on parenting behavior and child outcomes.
Clinical Trial Protocol
- Prior to the Implementation Phase (i.e., clinical trial), participating agencies will be randomized to either high- or low-intensity coaching conditions.
- Conditions
- Depression
- Being tested
- Mom-Net, Treatment as Usual/Waitlist
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mom-NetBehavioural
Mom-Net is a guided Internet intervention. Mom-Net is distinct from other CBT interventions for depression in addressing the link between maternal depression and parenting. Mom-Net's content includes core CBT skills taught in ways that are relevant to one's parenting interactions. Mothers will participate in Mom-Net with either high- or low-intensity coaching as determined by which version their HS was randomized to offer. Coaching is provided by HS staff.
In the high-intensity version, coaches provide support both for engaging with the intervention and for learning content. Coaching phone calls occur weekly (20-30 min call per session). In the low-intensity version, coaches provides supportive accountability for engaging with the intervention. Mothers participate in 4 (10-15) min calls occurring post-randomization, and 3- and 6-weeks later.
Treatment as Usual/WaitlistBehavioural
HS sites provide ongoing social and instrumental support to parents, including helping to connect families to needed services including community mental health providers. Additionally, research staff will provide lists of local mental health providers and information to support treatment seeking. Research staff will also provide National Crisis Lines for Mental Health Emergencies. Staff will inform participants to call research staff if they have trouble accessing services so that staff may provide additional help. Finally, staff will share a case note documenting referrals with the women's family service worker, so that worker may provide locally based assistance to the woman in accessing services. Subsequent to T2 assessment, participants in the TAU/Waitlist condition, will be offered the Mom-Net intervention variant (high- v low-intensity coaching) being provided by their respective HS agencies
| Study group | Role | What they receive |
|---|---|---|
| Mom-Net | Experimental | Mom-Net is a guided Internet intervention. Mom-Net is distinct from other CBT interventions for depression in addressing the link between maternal depression and parenting. Mom-Net's content includes core CBT skills taught in ways that are relevant to one's parenting interactions. Mothers will participate in Mom-Net with either high- or low-intensity coaching as determined by which version their HS was randomized to offer. Coaching is provided by HS staff.
In the high-intensity version, coaches provide support both for engaging with the intervention and for learning content. Coaching phone calls occur weekly (20-30 min call per session). In the low-intensity version, coaches provides supportive accountability for engaging with the intervention. Mothers participate in 4 (10-15) min calls occurring post-randomization, and 3- and 6-weeks later. Receives: Behavioral: Mom-Net |
| Treatment as Usual/Waitlist | Active comparator | HS sites provide ongoing social and instrumental support to parents, including helping to connect families to needed services including community mental health providers. Additionally, research staff will provide lists of local mental health providers and information to support treatment seeking. Research staff will also provide National Crisis Lines for Mental Health Emergencies. Staff will inform participants to call research staff if they have trouble accessing services so that staff may provide additional help. Finally, staff will share a case note documenting referrals with the women's family service worker, so that worker may provide locally based assistance to the woman in accessing services. Subsequent to T2 assessment, participants in the TAU/Waitlist condition, will be offered the Mom-Net intervention variant (high- v low-intensity coaching) being provided by their respective HS agencies. Receives: Behavioral: Treatment as Usual/Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 (PHQ-9)
Well-established measure of maternal depression with 9 self-report items, each rated on a 0 (not at all) to 3 (nearly every day) scale; total score will be used; interpretation: scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe,and severe depression, respectively. Total score will be used to examine change from baseline to subsequent assessments.
Measured: Assessing change between baseline, post-intervention (5 months), and follow up (12 months)
Maternal Acceptability (Modified System Usability Scale)
Implementation Outcome Variable. 14-item scale, rated on a 1-5 response scale. Will examine perceived helpfulness of Mom-Net content, activities, and coach calls. This scale has been used in investigators' prior Mom-Net research. The summed-item total score will be used, with a scale range of 14-70.
Measured: Post intervention ( 5 months)
Screening Reach (Reach)
Implementation Outcome. Screening rates will be calculated as the number of PHQ-9 screeners administered within each agency each year divided by the family HS enrollment (with a female-identified parent-figure). The metric will represent the percentage of mothers in each agency who were reached, with a range of 0-100.
Measured: End of screening in year 2 of implementation
Implementation Reach (IReach)
Implementation Outcome. Calculated as the number of Mom-Net eligible mothers screened within each agency divided by the number of mothers within each agency initiating Mom-Net intervention with a within-agency range of 0-100%.
Measured: End of Implementation in Year 2
Maternal Engagement (Engage)
Number of modules (0-8) and coach calls completed, page views (0-120), and program visits (0- no upper limit). These well-established indices of usage will be collected in real time.
Measured: Change between base-line and 5-month assessments
Secondary outcomes (10)
Parent Behavior Inventory (PBI)
Subscales will all be used to examine change in maternal behavior from baseline through subsequent assessment points; subscale total scores will be used; all items rated on a 0 (I don't do this) to 5 (I often do this) scale and summed for subscale total; Supportive/Engaged sub-scale range 0-55, Hostile/Coercive subscale range 0-45.
Measured: Change between Baseline and 5- and 12-month follow-up
Parenting Sense of Competence (PSOC)
Will use will three metrics to assess change in maternal sense of competence from Baseline through subsequent assessments: Total score, 17 items; Efficacy subscale, 8 items, Valuing/Comfort subscale, 9 items; all items are rated on a 1 (Strongly Agree) to 6 (Strongly Disagree) scale. Items will be summed to form: Total score (range of 17-102), Efficacy score (range 4-48) and Valuing/Comfort score (range 9-54). For total and subscale scores, a high score will reflect strong competence.
Measured: Change between Baseline and 5- and 12-month follow-up
Child Behavior Checklist (CBCL 1 ½ - 5 years)
Well-established measure of child internalizing/externalizing behavior; all items rated on 0 (not true), 1 (somewhat or sometimes true), 2 (very true or often true) scale; Both the Internalizing (36 items) and externalizing (24 items) subscales will be used, with raw score ranges of 0-72 and 0-48, respectively. Raw scores will be used in analysis of the age-associated t-scores.
Measured: Change between Baseline and 5- and 12-month follow-up
Child Behavior Checklist Teacher Report Form (C-TRF)
Well-established measure used to examine change in child internalizing/externalizing behavior; all items rated on 0 (not true), 1(somewhat or sometimes true), 2 (very true or often true) scale; Both the internalizing (32 items) and externalizing (34 items) subscales will be used, with raw score ranges of 0-64 and 0-68, respectively. Will be used in analysis of the t-scores associated with the raw score totals.
Measured: Change between Baseline and 5- and 12-month follow-up
Aggressive Interpersonal Behavior (Proportion)
The Living in Family Environments (LIFE) and Dyadic Parent-Child Interaction Coding System (DPICS) are two systems for coding family interactions. Investigators are using the LIFE affective codes and the DPICS verbal codes. Though the LIFE has verbal codes, the DPICS verbal codes are more developmentally appropriate. This approach has been used in earlier work. This outcome reflects the proportion of aggressive interpersonal behavior across the duration of the interaction.
Measured: Change between Baseline and 2-4 month assessment
Aggressive Interpersonal Behavior (Duration)
The Living in Family Environments (LIFE) and Dyadic Parent-Child Interaction Coding System (DPICS) are two systems for coding family interactions. Investigators are using the LIFE affective codes and the DPICS verbal codes. Though the LIFE has verbal codes, the DPICS verbal codes are more developmentally appropriate. This approach has been used in earlier work. This outcome reflects the duration per episode of aggressive interpersonal behavior observed during the interaction.
Measured: Change between Baseline and 2-4 month assessment
Positive Interpersonal Behavior (Proportion)
The Living in Family Environments (LIFE) and Dyadic Parent-Child Interaction Coding System (DPICS) are two systems for coding family interactions. Investigators are using the LIFE affective codes and the DPICS verbal codes. Though the LIFE has verbal codes, the DPICS verbal codes are more developmentally appropriate. This approach has been used in earlier work. This outcome reflects the proportion of positive interpersonal behavior across the duration of the interaction.
Measured: Change between Baseline and 2-4 month assessment
Positive Interpersonal Behavior (Duration)
The Living in Family Environments (LIFE) and Dyadic Parent-Child Interaction Coding System (DPICS) are two systems for coding family interactions. Investigators are using the LIFE affective codes and the DPICS verbal codes. Though the LIFE has verbal codes, the DPICS verbal codes are more developmentally appropriate. This approach has been used in earlier work. This outcome reflects the duration per episode of positive interpersonal behavior observed during the interaction.
Measured: Change between Baseline and 2-4 month assessment
The Work and Social Adjustment Scale
The Work and Social Adjustment Scale (WSAS) assesses the impact of mental health difficulties on ability to function in the context of work, home management, social leisure, private leisure, and personal or family relationships. Possible scores range from 0 to 40, where lower scores indicate fewer symptoms.
Measured: Change between Baseline and 2-4 month assessment
5-item World Health Organization Well-Being Index
The Well-Being Index is a short self-report measure assessing current wellbeing. Possible scores range from 0 to 25, where higher scores indicate better quality of life.
Measured: Change between Baseline and 2-4 month assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start1 Dec 2022
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Head Start (HS) agencies will be randomized to offer Mom-Net with either high- or low- intensity coaching. Subsequently, participants will be randomized to either the Mom-Net condition offered by their child's HS agency or to Treatment as Usual within the community/Waitlist (TAU/WL). Assessments will be conducted at T1- prior to participant randomization, at T2- subsequent to the conclusion of the intervention period, and at T3 1 year after T1. Subsequent to the T2 assessments, participants in the TAU/WL condition will be offered the opportunity to participate in the Mom-Net version offered by their HS agency. The T3 assessment will thus enable us to examine Maintenance of effects for those in the Mom-Net condition, and Replication of Mom-Net within group effects for those in the TAU/WL condition.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 960 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward G Feil, Ph.D., Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142384
- Sponsor's protocol ID
- MH120237
- Status last verified
- Aug 2026
- First submitted
- 29 Sep 2021
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified participant data will be available through the National Institute of Mental Health (NIMH) Data Archive (NDA)
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICBT for Maternal Depression: Community Implementation in Head Start
- ClinicalTrials.gov ID
- NCT05142384
- Acronym / sponsor ID
- MH120237
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 960 participants (estimated)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 2 Dec 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.
Low income women of childbearing age are at increased risk for depression and often do not receive needed treatment. Investigators developed Mom-Net, an on-line cognitive behavioral treatment (CBT) for depression to address the needs of low income women of childbearing age. The intervention program also includes live coaching to help the mothers engage and learn the CBT material. Mom-Net has been shown to be highly effective in reducing depressive symptoms and improving parenting behavior and child adjustment, in earlier controlled trials. In this project the investigators are examining whether access to Mom-Net can be expanded by delivering it in Head Starts (HS).
To address that broad question, the investigators will focus on two sets of scientific questions:
- Implementation Questions: e.g., Can HS agencies deliver the program successfully; do HSs choose to sustain the program after the research project ends; what agency characteristics are associated with successful delivery of Mom-Net);
- Effectiveness Questions: e.g., Does Mom-Net reduce maternal depression when delivered by Head Start agencies, with HS staff doing the coaching?
Head Start agencies will be randomized to deliver either Mom-Net with the usual high-intensity coaching or with a low-intensity coaching alternative. Within each agency, depressed mothers will be randomized to receive either: 1) Mom-Net program; or 2) Treatment as Usual (TAU;) referral to community mental health providers). Mothers initially assigned to the TAU condition, will have the option of receiving Mom-Net at a later date. Mothers will participate in assessments of depressive symptoms, parenting behavior, and child adjustment at Time 1 (T1; prior to randomization); and Time 2 (T2; after the intervention period) and Time 3 (T3; one year after T1).
Detailed description
Background:
Low income women of childbearing age are at disproportionate risk for depressive syndromes and, despite the availability of efficacious interventions, often do not receive needed treatment. The investigators developed Mom-Net, a remote, coach-facilitated, Internet-based intervention adapted from an empirically-supported cognitive behavioral treatment (CBT) for depression to address the needs of depressed mothers. Two randomized control trials demonstrated Mom-Net to be highly effective in reducing depressive symptoms and improving parenting behavior and child adjustment. In this project investigators seek to examine whether the reach of the Mom-Net intervention can be expanded by implementing within the Head Start Environment.
Investigators are using a hybrid type 2, Effectiveness-Implementation design to compare two implementation approaches for the delivery of Mom-Net, one with its existing high-intensity coaching approach, and one making use of a low-intensity coaching, designed to provide supportive accountability, but not psychoeducational support. Investigators will follow the Exploration, Preparation, Implementation, and Sustainment process model (EPIS) to guide the evaluation, with the Clinical Trial component primarily constituting the Implementation phase.
Clinical Trial Aims:
- Examine effectiveness and Implementation outcomes of Mom-Net within Head-Start, randomizing agencies to implementation approach (i.e., high- vs low-intensity coaching) and mothers within agency, to either Mom-Net or Treatment as Usual (TAU)/waitlist conditions.
- Compare the two Mom-Net implementation approaches on: 1) implementation outcomes including reach, acceptability, fidelity, and cost; and 2) effectiveness outcomes including self-reported maternal depressive symptoms (primary outcome), parenting behavior, and child emotional and behavioral functioning (secondary outcomes).
- Examine the effectiveness of each Mom-Net implementation approach relative to TAU on the primary and secondary outcomes listed above.
- Consistent with an experimental therapeutic approach, investigators will examine the mediating influence of changes in maternal functioning associated with core Mom-Net skills on maternal depressive symptoms. Mediators to be examined include behavior activation, negative cognitive styles, social support, and belief that mood can be regulated. Investigators will also examine the mediating influence of change in maternal depressive symptoms on parenting behavior and child outcomes.
Clinical Trial Protocol
- Prior to the Implementation Phase (i.e., clinical trial), participating agencies will be randomized to either high- or low-intensity coaching conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Head Start (HS) agencies will be randomized to offer Mom-Net with either high- or low- intensity coaching. Subsequently, participants will be randomized to either the Mom-Net condition offered by their child's HS agency or to Treatment as Usual within the community/Waitlist (TAU/WL). Assessments will be conducted at T1- prior to participant randomization, at T2- subsequent to the conclusion of the intervention period, and at T3 1 year after T1. Subsequent to the T2 assessments, participants in the TAU/WL condition will be offered the opportunity to participate in the Mom-Net version offered by their HS agency. The T3 assessment will thus enable us to examine Maintenance of effects for those in the Mom-Net condition, and Replication of Mom-Net within group effects for those in the TAU/WL condition.
| Arm | Type | Receives |
|---|---|---|
| Mom-Net | Experimental | Behavioral: Mom-NetMom-Net is a guided Internet intervention. Mom-Net is distinct from other CBT interventions for depression in addressing the link between maternal depression and parenting. Mom-Net's content includes core CBT skills taught in ways that are relevant to one's parenting interactions. Mothers will participate in Mom-Net with either high- or low-intensity coaching as determined by which version their HS was randomized to offer. Coaching is provided by HS staff. In the high-intensity version, coaches provide support both for engaging with the intervention and for learning content. Coaching phone calls occur weekly (20-30 min call per session). In the low-intensity version, coaches provides supportive accountability for engaging with the intervention. Mothers participate in 4 (10-15) min calls occurring post-randomization, and 3- and 6-weeks later. |
| Treatment as Usual/Waitlist | Active comparator | Behavioral: Treatment as Usual/WaitlistHS sites provide ongoing social and instrumental support to parents, including helping to connect families to needed services including community mental health providers. Additionally, research staff will provide lists of local mental health providers and information to support treatment seeking. Research staff will also provide National Crisis Lines for Mental Health Emergencies. Staff will inform participants to call research staff if they have trouble accessing services so that staff may provide additional help. Finally, staff will share a case note documenting referrals with the women's family service worker, so that worker may provide locally based assistance to the woman in accessing services. Subsequent to T2 assessment, participants in the TAU/Waitlist condition, will be offered the Mom-Net intervention variant (high- v low-intensity coaching) being provided by their respective HS agencies. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Elevated symptoms of depression (i.e., Patient Health Questionnaire or Edinburgh Postnatal Depression Scale score at or above 10)
- Have a child 2-5 years enrolled in a participating Head Start; be able to communicate in English or Spanish.
- 2-5 years of age and enrolled in participation Head Start
Key exclusion criteria (3 listed)
- Evidence of psychosis or other major mental illness or cognitive disability (observed during recruitment or by HS report) that would interfere with meaningful participation
- Endorsed score of 3 on final item of the PHQ9 or EPDS indicating frequent thoughts of suicide. Could be enrolled at later date if elevated risk ameliorates
- No exclusion criteria
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-NetMom-Net is a guided Internet intervention. Mom-Net is distinct from other CBT interventions for depression in addressing the link between maternal depression and parenting. Mom-Net's content includes core CBT skills taught in ways that are relevant to one's parenting interactions. Mothers will participate in Mom-Net with either high- or low-intensity coaching as determined by which version their HS was randomized to offer. Coaching is provided by HS staff. In the high-intensity version, coaches provide support both for engaging with the intervention and for learning content. Coaching phone calls occur weekly (20-30 min call per session). In the low-intensity version, coaches provides supportive accountability for engaging with the intervention. Mothers participate in 4 (10-15) min calls occurring post-randomization, and 3- and 6-weeks later. | Behavioural | Mom-Net |
| Treatment as Usual/WaitlistHS sites provide ongoing social and instrumental support to parents, including helping to connect families to needed services including community mental health providers. Additionally, research staff will provide lists of local mental health providers and information to support treatment seeking. Research staff will also provide National Crisis Lines for Mental Health Emergencies. Staff will inform participants to call research staff if they have trouble accessing services so that staff may provide additional help. Finally, staff will share a case note documenting referrals with the women's family service worker, so that worker may provide locally based assistance to the woman in accessing services. Subsequent to T2 assessment, participants in the TAU/Waitlist condition, will be offered the Mom-Net intervention variant (high- v low-intensity coaching) being provided by their respective HS agencies | Behavioural | Treatment as Usual/Waitlist |
Primary outcome
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Assessing change between baseline, post-intervention (5 months), and follow up (12 months)
Well-established measure of maternal depression with 9 self-report items, each rated on a 0 (not at all) to 3 (nearly every day) scale; total score will be used; interpretation: scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe,and severe depression, respectively. Total score will be used to examine change from baseline to subsequent assessments.
Maternal Acceptability (Modified System Usability Scale)
Time frame: Post intervention ( 5 months)
Implementation Outcome Variable. 14-item scale, rated on a 1-5 response scale. Will examine perceived helpfulness of Mom-Net content, activities, and coach calls. This scale has been used in investigators' prior Mom-Net research. The summed-item total score will be used, with a scale range of 14-70.
Screening Reach (Reach)
Time frame: End of screening in year 2 of implementation
Implementation Outcome. Screening rates will be calculated as the number of PHQ-9 screeners administered within each agency each year divided by the family HS enrollment (with a female-identified parent-figure). The metric will represent the percentage of mothers in each agency who were reached, with a range of 0-100.
Implementation Reach (IReach)
Time frame: End of Implementation in Year 2
Implementation Outcome. Calculated as the number of Mom-Net eligible mothers screened within each agency divided by the number of mothers within each agency initiating Mom-Net intervention with a within-agency range of 0-100%.
Maternal Engagement (Engage)
Time frame: Change between base-line and 5-month assessments
Number of modules (0-8) and coach calls completed, page views (0-120), and program visits (0- no upper limit). These well-established indices of usage will be collected in real time.
10 secondary outcomes
Parent Behavior Inventory (PBI)
Time frame: Change between Baseline and 5- and 12-month follow-up
Parenting Sense of Competence (PSOC)
Time frame: Change between Baseline and 5- and 12-month follow-up
Child Behavior Checklist (CBCL 1 ½ - 5 years)
Time frame: Change between Baseline and 5- and 12-month follow-up
Child Behavior Checklist Teacher Report Form (C-TRF)
Time frame: Change between Baseline and 5- and 12-month follow-up
Aggressive Interpersonal Behavior (Proportion)
Time frame: Change between Baseline and 2-4 month assessment
Aggressive Interpersonal Behavior (Duration)
Time frame: Change between Baseline and 2-4 month assessment
Positive Interpersonal Behavior (Proportion)
Time frame: Change between Baseline and 2-4 month assessment
Positive Interpersonal Behavior (Duration)
Time frame: Change between Baseline and 2-4 month assessment
The Work and Social Adjustment Scale
Time frame: Change between Baseline and 2-4 month assessment
5-item World Health Organization Well-Being Index
Time frame: Change between Baseline and 2-4 month assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Yes. All de-identified participant data will be available through the National Institute of Mental Health (NIMH) Data Archive (NDA)
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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.
Edward G Feil, Ph.D. principal investigator
Oregon Research Institute
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-Net and Treatment as Usual/Waitlist in people with Depression, run by Oregon Research Institute 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 12 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edward G Feil, Ph.D. (541-484-2123, Edf@ori.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 (PHQ-9) (time frame: Assessing change between baseline, post-intervention (5 months), and follow up (12 months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2026.