DepressionNCT01826903
Perinatal Depression Treatment and Child Development
An observational study of Depression, run by Duke University at 1 site in Pakistan.
Trial summary
The purpose of this study is to examine whether the successful perinatal depression intervention among mothers (Thinking Healthy Programme, THP) has led to improved developmental outcomes in the children 6 years later. Read more about this study
- Who is it for?
- Ages 6 to 7 years
- Conditions the study is for
- Depression
- How many people
- 964 participants
- Where
- 1 sitePakistan
- Study dates
- Jul 2012to Oct 2014
- Phase
- Observational
- 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 6 to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population includes children of women who participated in the Thinking Healthy Programme and children of women who were eligible for participation in the Thinking Healthy Programme but who screened negative for depression at the time.
Who may be able to join
- children of women who were eligible to participate in the Thinking Healthy Programme
Who cannot join
- developmental disability, visual or hearing impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perinatal Depression Treatment and Child Development: A Follow-Up of the Thinking Healthy Programme
The purpose of this study is to examine whether the successful perinatal depression intervention among mothers (Thinking Healthy Programme, THP) has led to improved developmental outcomes in the children 6 years later. Economic and human resources aspects of the intervention will also be evaluated to determine overall societal benefits from investment in such a program, feasibility of scaling up the intervention and its sustainability in the long-term. The primary hypothesis is that children of mothers who participated in the THP will have better cognitive outcomes and socio-emotional functioning when compared to children of mothers randomized to the control group.
- Conditions
- Depression
- Keywords
- Depression, Cognitive Behavior Therapy, Child Development
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| depressed mother/child dyad - intervention | Not described | |
| depressed mother/child dyad - no intervention | Not described | |
| non-depressed mother/child dyad | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate of general intelligence
Measured: Re-enrollment visit, approximately 7 years post-intervention
Measures of executive functions
Working memory, cognitive flexibility, inhibitory control, and sustained attention will be measured by standard tests of cognitive functioning.
Measured: Re-enrollment visit, approximately 7 years post-intervention
Level of literacy and numeracy
Measured: Re-enrollment visit, approximately 7 years post-intervention
Presence of behavioral and emotional problems (socio-emotional development)
Measured: Re-enrollment visit, approximately 7 years post-intervention
Secondary outcomes (2)
Height-for-age
Measured: Re-enrollment visit, approximately 7 years post-intervention
Weight-for-age
Measured: Re-enrollment visit, approximately 7 years post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startJul 2012
- Primary completionJun 2014
- Study completionOct 2014
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 Duke UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 964 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Human Development Research Foundation, Pakistan, Grand Challenges Canada
- Responsible party
- Sponsor
- Investigators
- Joanna Maselko, ScD, Principal investigator, Duke UniversitySiham Sikander, PhD, Principal investigator, Human Development Research Foundation, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826903
- Sponsor's protocol ID
- Pro00034166
- Other IDs
- Saving Brains #0058, ISRCTN65316374
- Status last verified
- Apr 2015
- First submitted
- 26 Mar 2013
- Last updated
- 20 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rahman A, Malik A, Sikander S, Roberts C, Creed F. Cognitive behaviour therapy-based intervention by community health workers for mothers with depression and their infants in rural Pakistan: a cluster-randomised controlled trial. Lancet. 2008 Sep 13;372(9642):902-9. doi: 10.1016/S0140-6736(08)61400-2.
PubMed 18790313
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perinatal Depression Treatment and Child Development: A Follow-Up of the Thinking Healthy Programme
- ClinicalTrials.gov ID
- NCT01826903
- Acronym / sponsor ID
- Pro00034166
- Conditions
- Depression
- Keywords
- Depression, Cognitive Behavior Therapy, Child Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 964 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Human Development Research Foundation, Pakistan, Grand Challenges Canada
- Study start
- Jul 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 9 Apr 2013 (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.
The purpose of this study is to examine whether the successful perinatal depression intervention among mothers (Thinking Healthy Programme, THP) has led to improved developmental outcomes in the children 6 years later. Economic and human resources aspects of the intervention will also be evaluated to determine overall societal benefits from investment in such a program, feasibility of scaling up the intervention and its sustainability in the long-term. The primary hypothesis is that children of mothers who participated in the THP will have better cognitive outcomes and socio-emotional functioning when compared to children of mothers randomized to the control group.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| depressed mother/child dyad - intervention | – | – |
| depressed mother/child dyad - no intervention | – | – |
| non-depressed mother/child dyad | – | – |
Who may qualify
- Ages
- 6 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population includes children of women who participated in the Thinking Healthy Programme and children of women who were eligible for participation in the Thinking Healthy Programme but who screened negative for depression at the time.
Key inclusion criteria (1 listed)
- children of women who were eligible to participate in the Thinking Healthy Programme
Key exclusion criteria (1 listed)
- developmental disability, visual or hearing impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimate of general intelligence
Time frame: Re-enrollment visit, approximately 7 years post-intervention
Measures of executive functions
Time frame: Re-enrollment visit, approximately 7 years post-intervention
Working memory, cognitive flexibility, inhibitory control, and sustained attention will be measured by standard tests of cognitive functioning.
Level of literacy and numeracy
Time frame: Re-enrollment visit, approximately 7 years post-intervention
Presence of behavioral and emotional problems (socio-emotional development)
Time frame: Re-enrollment visit, approximately 7 years post-intervention
2 secondary outcomes
Height-for-age
Time frame: Re-enrollment visit, approximately 7 years post-intervention
Weight-for-age
Time frame: Re-enrollment visit, approximately 7 years post-intervention
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 20 Apr 2015.
- Background: PubMed 18790313Rahman A, Malik A, Sikander S, Roberts C, Creed F. Cognitive behaviour therapy-based intervention by community health workers for mothers with depression and their infants in rural Pakistan: a cluster-randomised controlled trial. Lancet. 2008 Sep 13;372(9642):902-9. doi: 10.1016/S0140-6736(08)61400-2.
Related trials for Depression
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
Recruiting
Cancer Pain Management Using a Web-based Intervention
Cancer of Breast, Depressive Symptoms
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
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.
Joanna Maselko, ScD principal investigator
Duke University
Siham Sikander, PhD principal investigator
Human Development Research Foundation, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Duke University at 1 site in Pakistan.
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 20 Apr 2015. 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 Pakistan. 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?
Estimate of general intelligence (time frame: Re-enrollment visit, approximately 7 years post-intervention). The study lists 4 primary outcomes in all. 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 NCT01826903, 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 20 Apr 2015.