Ignite Creation Date:
2024-05-06 @ 12:16 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01535352
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2012-02-14
Brief Title:
Depressed Mothers in Rural Areas Web-Facilitated Cognitive Behavioral Treatment
Sponsor:
Oregon Research Institute
Organization:
Oregon Research Institute
Study Overview
Official Title:
Depressed Mothers in Rural Areas Web-Facilitated Cognitive Behavioral Treatment
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Mom-NetRCT
Brief 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 The proposed project is designed to evaluate Mom-Net an internet-facilitated cognitive-behavioralCBT intervention for depression adapted from Lewinsohns 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 eg 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 symptomsSubsequent 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 Lewinsohns 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None