Interpersonal Therapy-Based Treatment to Prevent Postpartum Depression in Adolescent Mothers
This trial is active, not recruiting.
|Treatment||interpersonal therapy-based treatment|
|Sponsor||Women and Infants Hospital of Rhode Island|
|Collaborator||National Institute of Mental Health (NIMH)|
|Start date||December 2011|
|End date||December 2017|
|Trial size||250 participants|
|Trial identifier||NCT01482832, R01MH093342|
The Specific Aim of this proposal is to conduct a randomized controlled trial to evaluate whether Project REACH (an interpersonal psychotherapy-based intervention) compared with a didactic attention-control program reduces the risk of PPD in adolescent mothers.
1. The intervention (Project REACH) will be significantly more efficacious than the control program in reducing the risk of PPD up to six months postpartum in adolescent mothers.
2. The decreased rate of major depression in the Project REACH group compared to the control program group will be sustained through one year postpartum.
3. Adolescent mothers in Project REACH compared to the control program group will have higher levels of maternal-child bonding.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Diagnosis of depression
time frame: within 6 months postpartum
Degree of depressive symptoms
time frame: pre-randomization; 34-36 weeks gestation; within 4 days postdelivery; postpartum weeks 6, 12, 24 and 52
Female participants from 12 years up to 19 years old.
Inclusion Criteria: - Less than 24 weeks pregnant - Not currently being treated for depression - Speaks and reads English fluently Exclusion Criteria: - Currently receiving mental health services from a health care provider - Meets DSM-IV criteria for an affective disorder, substance use disorder, or psychosis
|Official title||Preventing Postpartum Depression in Adolescent Mothers|
|Principal investigator||Maureen G Phipps, MD, MPH|
|Description||Each year, more than 400,000 births in the United States are to mothers less than 20 years old. Alarmingly, approximately 25-36% of teen mothers experience postpartum depression (PPD), a condition associated with significant social and health morbidity. PPD places teen mothers and their children at great risk during an already challenging time in their lives. Preventing PPD in this vulnerable population is essential to improving overall health. Project REACH is a randomized controlled trial, conducted over five years, to evaluate whether our novel preventive intervention compared to a didactic attention control reduces the risk of PPD in adolescent mothers. The intervention, REACH (Relax, Encourage, Appreciate, Communicate, Help), is based on Interpersonal Psychotherapy (IPT) and targets those factors that may play a significant role in the development of PPD in adolescent mothers (i.e., poor social support, role transitions and life stressors). The control condition includes didactic prenatal education sessions. Project REACH builds on the foundation of our NIMH-funded treatment development project and pilot study (R34 MH077588). The pilot study demonstrated feasibility, acceptability and initial efficacy in a small sample. The current R01 proposal aims to evaluate the efficacy of the Project REACH intervention in reducing the risk of PPD.|
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