DepressionNCT00105573
Interventions for Depressed Low Income Mothers and Their Infants
A study testing Maternal interpersonal psychotherapy (IP), Infant-parent psychotherapy and Informational meetings plus treatment as usual in people with Depression, run by University of Rochester at 1 site in United States.
Trial summary
This study will compare three interventions for depressed, low income mothers and determine which is most effective in treating maternal depression and in fostering development in infants. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Maternal interpersonal psychotherapy (IP), Infant-parent psychotherapy and Informational meetings plus treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Apr 2010
- 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 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Current diagnosis of depression
- Mother of an infant 9 to 11 months of age
- Low income, defined as less than $25,000 for a family of two or less than $31,400 for a family of three (add approximately $7,960 for each additional family member)
Who cannot join
- Current substance abuse
- Severe mental or physical limitations that would interfere with the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention for Infants of Low-Income Depressed Mothers
This study will compare three interventions for depressed, low income mothers and determine which is most effective in treating maternal depression and in fostering development in infants.
Read the detailed description
Poorly educated, low income mothers are at high risk for becoming depressed. The effects of living in poverty and being reared by a depressed parent can be detrimental to an infant's development. Effective interventions to reduce maternal depression and strengthen the mother-infant relationships are needed.
Participants will be randomly assigned to one of three groups. Group 1 mothers will receive 16 weekly sessions of interpersonal psychotherapy (IP) designed to directly treat maternal depression. Group 1 participants will have monthly follow-up visits for 1 year. Participants in Group 2 will receive 16 weekly sessions of IP followed by 1 year of in-home, infant-parent psychotherapy, an intervention addressing relationship difficulties between depressed mothers and their infants. Group 3 mothers will be invited to attend informational meetings as well as be referred to local services available to people with depression.
All mother-child pairs will be evaluated when the child is 12, 16, 24, and 36 months of age. Evaluations will involve questionnaires, diagnostic interviews, developmental assessments, and video- and audio-taped measures.
- Conditions
- Depression
- Being tested
- Maternal interpersonal psychotherapy (IP), Infant-parent psychotherapy, Informational meetings plus treatment as usual
- Keywords
- Mother-Child Relations, Infant, Child Development, Poverty
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal interpersonal psychotherapy (IP)Behavioural
Participants will receive 16 weekly sessions of maternal IP designed to directly treat maternal depression.
Infant-parent psychotherapyBehavioural
Participants will receive 1 year of in-home, infant-parent psychotherapy, an intervention addressing relationship difficulties between depressed mothers and their infants.
Informational meetings plus treatment as usualBehavioural
Participants will be invited to attend informational meetings as well as be referred to local services available to people with depression.
| Study group | Role | What they receive |
|---|---|---|
| Interpersonal Psychotherapy | Experimental | Participants will receive interpersonal psychotherapy for depression. Receives: Behavioral: Maternal interpersonal psychotherapy (IP) |
| Interpersonal psychotherapy/child-parent psychotherapy | Experimental | Participants will receive interpersonal psychotherapy for depression plus 1 year of in-home, child-parent psychotherapy. Receives: Behavioral: Maternal interpersonal psychotherapy (IP); Behavioral: Infant-parent psychotherapy |
| Enhanced community standard | Active comparator | Participants will be invited to attend informational meetings as well as be referred to local services available to people with depression. Receives: Behavioral: Informational meetings plus treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal depression
Measured: Measured when the child is 12, 16, 24, 36, and 48 months of age
Child development
Measured: Measured when the child is 12, 16, 24, 36, and 48 months of age
Infant-parent attachment
Measured: Measured when the child is 12, 16, 24, 36, and 48 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2005 (estimated)
- Study startJan 2004
- Primary completionApr 2010
- Study completionApr 2010
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.
- More trials run by University of RochesterThe 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
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Sheree Toth, University of Rochester
- Investigators
- Sheree Toth, PhD, Principal investigator, Mount Hope Family Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105573
- Sponsor's protocol ID
- R01MH067792
- Other IDs
- R01MH067792, DSIR 84-CTP
- Status last verified
- Apr 2013
- First submitted
- 15 Mar 2005
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention for Infants of Low-Income Depressed Mothers
- ClinicalTrials.gov ID
- NCT00105573
- Acronym / sponsor ID
- R01MH067792
- Conditions
- Depression
- Keywords
- Mother-Child Relations, Infant, Child Development, Poverty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2004
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 16 Mar 2005 (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.
This study will compare three interventions for depressed, low income mothers and determine which is most effective in treating maternal depression and in fostering development in infants.
Detailed description
Poorly educated, low income mothers are at high risk for becoming depressed. The effects of living in poverty and being reared by a depressed parent can be detrimental to an infant's development. Effective interventions to reduce maternal depression and strengthen the mother-infant relationships are needed.
Participants will be randomly assigned to one of three groups. Group 1 mothers will receive 16 weekly sessions of interpersonal psychotherapy (IP) designed to directly treat maternal depression. Group 1 participants will have monthly follow-up visits for 1 year. Participants in Group 2 will receive 16 weekly sessions of IP followed by 1 year of in-home, infant-parent psychotherapy, an intervention addressing relationship difficulties between depressed mothers and their infants. Group 3 mothers will be invited to attend informational meetings as well as be referred to local services available to people with depression.
All mother-child pairs will be evaluated when the child is 12, 16, 24, and 36 months of age. Evaluations will involve questionnaires, diagnostic interviews, developmental assessments, and video- and audio-taped measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interpersonal Psychotherapy | Experimental | Behavioral: Maternal interpersonal psychotherapy (IP)Participants will receive interpersonal psychotherapy for depression. |
| Interpersonal psychotherapy/child-parent psychotherapy | Experimental | Behavioral: Maternal interpersonal psychotherapy (IP), Behavioral: Infant-parent psychotherapyParticipants will receive interpersonal psychotherapy for depression plus 1 year of in-home, child-parent psychotherapy. |
| Enhanced community standard | Active comparator | Behavioral: Informational meetings plus treatment as usualParticipants will be invited to attend informational meetings as well as be referred to local services available to people with depression. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Current diagnosis of depression
- Mother of an infant 9 to 11 months of age
- Low income, defined as less than $25,000 for a family of two or less than $31,400 for a family of three (add approximately $7,960 for each additional family member)
Key exclusion criteria (2 listed)
- Current substance abuse
- Severe mental or physical limitations that would interfere with the study
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 |
|---|---|---|
| Maternal interpersonal psychotherapy (IP)Participants will receive 16 weekly sessions of maternal IP designed to directly treat maternal depression. | Behavioural | Interpersonal Psychotherapy, Interpersonal psychotherapy/child-parent psychotherapy |
| Infant-parent psychotherapyParticipants will receive 1 year of in-home, infant-parent psychotherapy, an intervention addressing relationship difficulties between depressed mothers and their infants. | Behavioural | Interpersonal psychotherapy/child-parent psychotherapy |
| Informational meetings plus treatment as usualParticipants will be invited to attend informational meetings as well as be referred to local services available to people with depression. | Behavioural | Enhanced community standard |
Primary outcome
Maternal depression
Time frame: Measured when the child is 12, 16, 24, 36, and 48 months of age
Child development
Time frame: Measured when the child is 12, 16, 24, 36, and 48 months of age
Infant-parent attachment
Time frame: Measured when the child is 12, 16, 24, 36, and 48 months of age
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 30 Apr 2013.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Sheree Toth, PhD principal investigator
Mount Hope Family Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal interpersonal psychotherapy (IP), Infant-parent psychotherapy and Informational meetings plus treatment as usual in people with Depression, run by University of Rochester 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 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 30 Apr 2013. 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?
Maternal depression (time frame: Measured when the child is 12, 16, 24, 36, and 48 months of age). The study lists 3 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 30 Apr 2013.