Maternal DepressionNCT02145273
Healthy Moms-Healthy Kids: Reducing Maternal Depression for Better Outcomes in Head Start Children
A study testing Interpersonal Psychotherapy for Depression -Group in people with Maternal Depression and Parenting Behavior, run by University of Southern California at 2 sites in United States.
Trial summary
Maternal depression is a pervasive problem that disproportionately affects low-income mothers. The effects of depression on mothers and their parenting result in many negative outcomes for children, particularly in terms of school readiness. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Maternal Depression, Parenting Behavior, Health
- What is being tested?
- Interpersonal Psychotherapy for Depression -Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2014to Sep 2018
- 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
- Mothers of children in Head Start with scores on screening measure that are in depressed or possibly depressed range to be assigned to intervention or TAU. Also will have additional control group of non depressed mothers
Who cannot join
- Not able to function in group environment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Institute, Inc.
Los Angeles, California, 90026
University of Southern California School of Social Work
Los Angeles, California, 90089
About this study
Maternal depression is a pervasive problem that disproportionately affects low-income mothers. The effects of depression on mothers and their parenting result in many negative outcomes for children, particularly in terms of school readiness. The proposed research will build on a successful partnership between the University of Southern California School of Social Work (USC) and Children's Institute, Inc. (CII) to implement and evaluate an evidence-based intervention, interpersonal psychotherapy for group (IPT-G), for Head Start mothers with depression or dysphoric mood with the goal of reducing their depression and promoting positive changes for both mothers and children. The objectives of the study are: (1) adapt IPT-G for a Head Start population of mothers with depression; (2) implement IPT-G via a randomized controlled trial in Head Start centers in Los Angeles County operated by CII; (3) evaluate the effects of the intervention on maternal depression, parenting behaviors, goal-directed behavior, interpersonal relationships, physical health, and child behavior and school readiness; and (4) develop a manual for use of the intervention in Head Start and disseminate findings nationally. The study will feature 2 groups of 60 mothers each, randomized by Head Start site; one will receive the intervention and the other services as usual. Outcomes for both mothers and children will be tracked for 2 years after the intervention, allowing for the evaluation of short- and long-term effects. The intervention will be delivered by Head Start mental health workers under the supervision of Scott Stuart, a national trainer of the intervention. This intervention has the potential to be a low-cost, high-impact intervention that can be replicated to other Head Start sites across the country to improve the lives of Head Start children and families.
- Conditions
- Maternal Depression, Parenting Behavior, Health, Interpersonal Relationships, Goal Directed Behavior, Child Behavior
- Being tested
- Interpersonal Psychotherapy for Depression -Group
- Keywords
- Maternal Depression, Interpersonal Psychotherapy, School Readiness
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal Psychotherapy for Depression -GroupBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Subjects screen positive for depression and are offered a group Therapy intervention for depression: Interpersonal Psychotherapy for Depression Group. Receives: Behavioral: Interpersonal Psychotherapy for Depression -Group |
| Control | No intervention | Subjects screen positive for depression and are offered Treatment as usual: External referral. |
| comparison | No intervention | Subjects screen negative for depression: no referral or intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory
Measured: At entry, completion of intervention, and every 6 months for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal DepressionStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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 3 conditions that will be followed for up to 2 years: control, intervention and comparison. Randomization is by site. Half the sites are control half are intervention. all possible subjects are screened for depression. if the subject is depressed they are invited in to control or intervention based on site, all non depressed subjects are invited into the comparison.
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferol Mennen, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145273
- Sponsor's protocol ID
- 90YR0074-01-00
- Other IDs
- 90YR0074-01
- Status last verified
- Apr 2017
- First submitted
- 19 May 2014
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Moms-Healthy Kids: Reducing Maternal Depression for Better Outcomes in Head Start Children
- ClinicalTrials.gov ID
- NCT02145273
- Acronym / sponsor ID
- 90YR0074-01-00
- Conditions
- Maternal Depression, Parenting Behavior, Health, Interpersonal Relationships, Goal Directed Behavior, Child Behavior
- Keywords
- Maternal Depression, Interpersonal Psychotherapy, School Readiness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 22 May 2014 (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.
Maternal depression is a pervasive problem that disproportionately affects low-income mothers. The effects of depression on mothers and their parenting result in many negative outcomes for children, particularly in terms of school readiness. The proposed research will build on a successful partnership between the University of Southern California School of Social Work (USC) and Children's Institute, Inc. (CII) to implement and evaluate an evidence-based intervention, interpersonal psychotherapy for group (IPT-G), for Head Start mothers with depression or dysphoric mood with the goal of reducing their depression and promoting positive changes for both mothers and children. The objectives of the study are: (1) adapt IPT-G for a Head Start population of mothers with depression; (2) implement IPT-G via a randomized controlled trial in Head Start centers in Los Angeles County operated by CII; (3) evaluate the effects of the intervention on maternal depression, parenting behaviors, goal-directed behavior, interpersonal relationships, physical health, and child behavior and school readiness; and (4) develop a manual for use of the intervention in Head Start and disseminate findings nationally. The study will feature 2 groups of 60 mothers each, randomized by Head Start site; one will receive the intervention and the other services as usual. Outcomes for both mothers and children will be tracked for 2 years after the intervention, allowing for the evaluation of short- and long-term effects. The intervention will be delivered by Head Start mental health workers under the supervision of Scott Stuart, a national trainer of the intervention. This intervention has the potential to be a low-cost, high-impact intervention that can be replicated to other Head Start sites across the country to improve the lives of Head Start children and families.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- There are 3 conditions that will be followed for up to 2 years: control, intervention and comparison. Randomization is by site. Half the sites are control half are intervention. all possible subjects are screened for depression. if the subject is depressed they are invited in to control or intervention based on site, all non depressed subjects are invited into the comparison.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Interpersonal Psychotherapy for Depression -GroupSubjects screen positive for depression and are offered a group Therapy intervention for depression: Interpersonal Psychotherapy for Depression Group. |
| Control | No intervention | –Subjects screen positive for depression and are offered Treatment as usual: External referral. |
| comparison | No intervention | –Subjects screen negative for depression: no referral or intervention. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Mothers of children in Head Start with scores on screening measure that are in depressed or possibly depressed range to be assigned to intervention or TAU. Also will have additional control group of non depressed mothers
Key exclusion criteria (1 listed)
- Not able to function in group environment
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 |
|---|---|---|
| Interpersonal Psychotherapy for Depression -Group | Behavioural | Intervention |
Primary outcome
Beck Depression Inventory
Time frame: At entry, completion of intervention, and every 6 months for 2 years
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 11 Jun 2019.
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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 Interpersonal Psychotherapy for Depression -Group in people with Maternal Depression and Parenting Behavior, run by University of Southern California 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 1 inclusion and 1 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 11 Jun 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?
Beck Depression Inventory (time frame: At entry, completion of intervention, and every 6 months for 2 years). 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 11 Jun 2019.