Depressive SymptomsNCT01453790
Parent Specific Depression Education and Motivation
A study testing Parent-Specific Depression Education and Motivation and General Depression Education-Motivation in people with Depressive Symptoms, run by University of California, Davis at 1 site in United States.
Trial summary
This project is an investigator-initiated, randomized-controlled trial of the effectiveness of written and verbal parent-specific depression education and motivational advice in increasing participants self-disclosed intention to seek follow-up care for possible depression symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Parent-Specific Depression Education and Motivation and General Depression Education-Motivation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jan 2012
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parent of a child between the ages of 2 days and 12 years who is a patient of the UC Davis Pediatric Clinic.
- Primary, female caregiver
- Feeling down, depressed, or hopeless or little interest or pleasure in doing things.
- Not currently receiving care from a mental health practitioner.
- Comfortable speaking English without an interpreter.
Who cannot join
- Parent of a child younger than 2 days or older than 12 years.
- Dad, Foster parent, or other short term guardian.
- Currently in treatment with a mental health practitioner.
- Limited English Proficiency
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center, General Pediatrics
Sacramento, California, 95817
About this study
Official title: Effectiveness of Parent Specific Depression Education and Motivation on Intent to Seek Follow-Up Care for Potential Depression Symptoms
This project is an investigator-initiated, randomized-controlled trial of the effectiveness of written and verbal parent-specific depression education and motivational advice in increasing participants self-disclosed intention to seek follow-up care for possible depression symptoms. The control condition is written and verbal general depression education and advice. Hypothesis: the office-based experimental intervention of written and verbal parent-specific depression and emotional health education and motivational advice increases intention to seek follow-up services for emotional health or depression, when compared to written and verbal general depression education and advice.
Read the detailed description
Maternal depression is a common problem, debilitating for mothers and affecting parenting practices with negative effects on the behavior, development, and physical health of children. The value of identifying and treating maternal depression for child development and well-being is well documented. Unfortunately, there are multiple barriers to the recognition and treatment of maternal depression. This is particularly problematic in younger women, as they are less often seen for health care. The overall objective of this project is to test whether the uptake of follow-up recommendations for potential depression by mothers identified by screening in clinical settings is improved by parent-specific targetting of depression education and motivational advice.
- Conditions
- Depressive Symptoms
- Being tested
- Parent-Specific Depression Education and Motivation, General Depression Education-Motivation
- Keywords
- depression, treatment, motivation to seek follow up
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-Specific Depression Education and MotivationBehavioural
Parent-specific written and verbal depression messages garnered from previous research were consolidated into a pamphlet and script, respectively. These are dispensed after randomization in the pediatric office. At two days, mothers in the experimental group receive a motivational telephone call.
General Depression Education-MotivationBehavioural
General depression education messages were compiled and are delivered verbally (scripted) and written (JAMA Depression Patient Page) after randomization in the pediatric office. At 2 days, mothers in the comparison group receive an attention control telephone call.
| Study group | Role | What they receive |
|---|---|---|
| Parent-Specific Depression Education-Motivation | Experimental | Mothers receive depression education (verbal and written) with messages targeted to parent status which are drawn from previous research. They also receive motivational messages at 2 days via telephone. Receives: Behavioral: Parent-Specific Depression Education and Motivation |
| General Depression Education | Active comparator | Mothers receive general depression education (verbal and written) which are drawn from previous research. They also receive attention control telephone calls at 2 days. Receives: Behavioral: General Depression Education-Motivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Follow-Up Care Seeking
Mothers' self-reported attempts at obtaining follow-up services for emotional health or depression.
Measured: at 2 weeks
Secondary outcomes (1)
Intention to Seek Depression Follow-Up Care
Three item scale measure of intention to seek care (any) for follow-up of positive depression screen.
Measured: at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2011 (estimated)
- Study startApr 2011
- Primary completionOct 2011
- Study completionJan 2012
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 Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Miracle Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453790
- Sponsor's protocol ID
- 214808
- Other IDs
- 214808-7
- Status last verified
- Jun 2012
- First submitted
- 11 Oct 2011
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Fernandez y Garcia E, Joseph J, Wilson MD, Hinton L, Simon G, Ludman E, Scott F, Kravitz RL. Pediatric-based intervention to motivate mothers to seek follow-up for depression screens: The Motivating Our Mothers (MOM) trial. Acad Pediatr. 2015 May-Jun;15(3):311-8. doi: 10.1016/j.acap.2014.11.008.
PubMed 25906700
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Parent Specific Depression Education and Motivation on Intent to Seek Follow-Up Care for Potential Depression Symptoms
- ClinicalTrials.gov ID
- NCT01453790
- Acronym / sponsor ID
- 214808
- Conditions
- Depressive Symptoms
- Keywords
- depression, treatment, motivation to seek follow up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Children's Miracle Network
- Study start
- Apr 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 18 Oct 2011 (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 project is an investigator-initiated, randomized-controlled trial of the effectiveness of written and verbal parent-specific depression education and motivational advice in increasing participants self-disclosed intention to seek follow-up care for possible depression symptoms. The control condition is written and verbal general depression education and advice. Hypothesis: the office-based experimental intervention of written and verbal parent-specific depression and emotional health education and motivational advice increases intention to seek follow-up services for emotional health or depression, when compared to written and verbal general depression education and advice.
Detailed description
Maternal depression is a common problem, debilitating for mothers and affecting parenting practices with negative effects on the behavior, development, and physical health of children. The value of identifying and treating maternal depression for child development and well-being is well documented. Unfortunately, there are multiple barriers to the recognition and treatment of maternal depression. This is particularly problematic in younger women, as they are less often seen for health care. The overall objective of this project is to test whether the uptake of follow-up recommendations for potential depression by mothers identified by screening in clinical settings is improved by parent-specific targetting of depression education and motivational advice.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent-Specific Depression Education-Motivation | Experimental | Behavioral: Parent-Specific Depression Education and MotivationMothers receive depression education (verbal and written) with messages targeted to parent status which are drawn from previous research. They also receive motivational messages at 2 days via telephone. |
| General Depression Education | Active comparator | Behavioral: General Depression Education-MotivationMothers receive general depression education (verbal and written) which are drawn from previous research. They also receive attention control telephone calls at 2 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Parent of a child between the ages of 2 days and 12 years who is a patient of the UC Davis Pediatric Clinic.
- Primary, female caregiver
- Feeling down, depressed, or hopeless or little interest or pleasure in doing things.
- Not currently receiving care from a mental health practitioner.
- Comfortable speaking English without an interpreter.
Key exclusion criteria (4 listed)
- Parent of a child younger than 2 days or older than 12 years.
- Dad, Foster parent, or other short term guardian.
- Currently in treatment with a mental health practitioner.
- Limited English Proficiency
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 |
|---|---|---|
| Parent-Specific Depression Education and MotivationParent-specific written and verbal depression messages garnered from previous research were consolidated into a pamphlet and script, respectively. These are dispensed after randomization in the pediatric office. At two days, mothers in the experimental group receive a motivational telephone call. | Behavioural | Parent-Specific Depression Education-Motivation |
| General Depression Education-MotivationGeneral depression education messages were compiled and are delivered verbally (scripted) and written (JAMA Depression Patient Page) after randomization in the pediatric office. At 2 days, mothers in the comparison group receive an attention control telephone call. | Behavioural | General Depression Education |
Primary outcome
Depression Follow-Up Care Seeking
Time frame: at 2 weeks
Mothers' self-reported attempts at obtaining follow-up services for emotional health or depression.
1 secondary outcome
Intention to Seek Depression Follow-Up Care
Time frame: at 2 weeks
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 May 2017.
- Derived from this study: PubMed 25906700Fernandez y Garcia E, Joseph J, Wilson MD, Hinton L, Simon G, Ludman E, Scott F, Kravitz RL. Pediatric-based intervention to motivate mothers to seek follow-up for depression screens: The Motivating Our Mothers (MOM) trial. Acad Pediatr. 2015 May-Jun;15(3):311-8. doi: 10.1016/j.acap.2014.11.008.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-Specific Depression Education and Motivation and General Depression Education-Motivation in people with Depressive Symptoms, run by University of California, Davis 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 5 inclusion and 4 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 May 2017. 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?
Depression Follow-Up Care Seeking (time frame: at 2 weeks). 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 NCT01453790, 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 30 May 2017; AzTrials last refreshed its copy on 3 Nov 2026.