DepressionPhase 2NCT00074789
Reducing Symptoms of Depression in Low-Income Mothers
A Phase 2 study testing Modified Interpersonal Therapy in people with Depression, run by University of North Carolina, Chapel Hill at 6 sites in United States.
Trial summary
This study will test the effectiveness of a short-term intervention in treating depressed young mothers with young children enrolled in Early Head Start Programs. Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Depression
- What is being tested?
- Modified Interpersonal Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2003to Jan 2009
- Phase
- Phase 2
- 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 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Score of 16 or higher on the Center for Epidemiological Studies Depression (CES-D) Scale
- Child who is 6 weeks to 30 months old
- Child who is enrolled in an Early Head Start program
Who cannot join
- Regular use of psychotropic medication
- Regular use of psychotherapy or drug/alcohol treatment
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Asheville City Schools Preschool-Early Head Start Program
Asheville, North Carolina, 28806
Chapel Hill Training Outreach Project, Inc. Early Head Start
Chapel Hill, North Carolina, 27514
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599-0001
W.A.G.E.S., Inc. Early Head Start Program
Goldsboro, North Carolina, 27534-2570
United Child Development Services, Inc. Early Head Start
Greensboro, North Carolina, 27406
P.E.A.C.E, Inc. Early Head Start
Syracuse, New York, 13203
About this study
Official title: Reducing Depressive Symptoms in Low-Income Mothers
This study will test the effectiveness of a short-term intervention in treating depressed young mothers with young children enrolled in Early Head Start Programs.
Read the detailed description
Limited resources, poor social support, and complex life problems contribute to the high prevalence and severity of depressive symptoms in low-income mothers. As depressive symptoms persist, they often rob young mothers of the energy they need for school, job training, and positive interaction with their children, which can negatively affect a child's language acquisition, intellectual development, and social conduct. This study will design and implement a home-based treatment to help young mothers manage their depressive symptoms, increase their social support, manage or resolve life issues, and effectively parent their infant or toddler through the use of EHS resources.
Mothers will be randomly assigned to receive either home-based interpersonal depression treatment or an attention control/usual care condition for 26 weeks. Assessments will be made at study start and Weeks 14, 22, and 26. Depression scales, interviews, and analyses of videotaped mother-child interactions will be used to assess participants. Stress, social support, and use of EHS services will be assessed.
- Conditions
- Depression
- Being tested
- Modified Interpersonal Therapy, Attention control/usual care
- Keywords
- Early Head Start Program
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Interpersonal TherapyBehavioural
Psychiatric mental health nurses will meet with participants 10 times, an hour each time, over a period of 14 weeks. The nurses will continue to work with the mothers over the next 8 weeks by phone, conducting 5 fifteen minute phone sessions.
Attention control/usual careBehavioural
Participants will receive the usual care for depression.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive home-based interpersonal depression treatment for 26 weeks Receives: Behavioral: Modified Interpersonal Therapy |
| 2 | Active comparator | Participants will receive attention control/usual care for 26 weeks Receives: Behavioral: Attention control/usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of depressive symptoms
Measured: Measured at Week 26
Secondary outcomes (1)
Mother child interactions
Measured: Measured at Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2003 (estimated)
- Study startJun 2003
- Primary completionSep 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Linda Beeber, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00074789
- Sponsor's protocol ID
- R01MH065524
- Other IDs
- R01MH065524, DSIR 83-ATAS, HILDA
- Status last verified
- Jun 2013
- First submitted
- 19 Dec 2003
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Salomon RE, Muscatell KA, Crandell J, Anderson RA, Beeber LS. A Preliminary Investigation of Psychoneurological Symptoms in Low-Income Mothers. Nurs Res. 2021 Set/Oct 01;70(5):325-333. doi: 10.1097/NNR.0000000000000518.
PubMed 33935214
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Depressive Symptoms in Low-Income Mothers
- ClinicalTrials.gov ID
- NCT00074789
- Acronym / sponsor ID
- R01MH065524
- Conditions
- Depression
- Keywords
- Early Head Start Program
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2003
- Primary completion
- Sep 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 22 Dec 2003 (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 test the effectiveness of a short-term intervention in treating depressed young mothers with young children enrolled in Early Head Start Programs.
Detailed description
Limited resources, poor social support, and complex life problems contribute to the high prevalence and severity of depressive symptoms in low-income mothers. As depressive symptoms persist, they often rob young mothers of the energy they need for school, job training, and positive interaction with their children, which can negatively affect a child's language acquisition, intellectual development, and social conduct. This study will design and implement a home-based treatment to help young mothers manage their depressive symptoms, increase their social support, manage or resolve life issues, and effectively parent their infant or toddler through the use of EHS resources.
Mothers will be randomly assigned to receive either home-based interpersonal depression treatment or an attention control/usual care condition for 26 weeks. Assessments will be made at study start and Weeks 14, 22, and 26. Depression scales, interviews, and analyses of videotaped mother-child interactions will be used to assess participants. Stress, social support, and use of EHS services will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Modified Interpersonal TherapyParticipants will receive home-based interpersonal depression treatment for 26 weeks |
| 2 | Active comparator | Behavioral: Attention control/usual careParticipants will receive attention control/usual care for 26 weeks |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Score of 16 or higher on the Center for Epidemiological Studies Depression (CES-D) Scale
- Child who is 6 weeks to 30 months old
- Child who is enrolled in an Early Head Start program
Key exclusion criteria (2 listed)
- Regular use of psychotropic medication
- Regular use of psychotherapy or drug/alcohol treatment
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 |
|---|---|---|
| Modified Interpersonal TherapyPsychiatric mental health nurses will meet with participants 10 times, an hour each time, over a period of 14 weeks. The nurses will continue to work with the mothers over the next 8 weeks by phone, conducting 5 fifteen minute phone sessions. | Behavioural | 1 |
| Attention control/usual careParticipants will receive the usual care for depression. | Behavioural | 2 |
Primary outcome
Level of depressive symptoms
Time frame: Measured at Week 26
1 secondary outcome
Mother child interactions
Time frame: Measured at Week 26
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 21 Jun 2013.
- Derived from this study: PubMed 33935214Salomon RE, Muscatell KA, Crandell J, Anderson RA, Beeber LS. A Preliminary Investigation of Psychoneurological Symptoms in Low-Income Mothers. Nurs Res. 2021 Set/Oct 01;70(5):325-333. doi: 10.1097/NNR.0000000000000518.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Modified Interpersonal Therapy in people with Depression, run by University of North Carolina, Chapel Hill at 6 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 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Level of depressive symptoms (time frame: Measured at Week 26). 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 NCT00074789, which also lists 1 linked publication.
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 21 Jun 2013.