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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01MH083647 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The current proposal is a randomized, controlled, clinical trial to evaluate the intergenerational impact of treating depressed mothers whose children suffer from psychiatric disorders.
This study will compare a psychotherapy for mothers that targets factors known to be associated with the intergenerational transmission of psychiatric disorders to a nonspecific psychotherapeutic control condition. It will evaluate outcomes in both children and mothers. A modified form of interpersonal psychotherapy for depression, IPT-MOMS, specifically addresses maternal depressive symptoms, maternal interpersonal functioning, and mother-child communication, all factors that contribute to psychiatric illness in youth (Swartz et al., 2006). This application proposes to recruit mother-child dyads, both of whom suffer from psychiatric illness, randomly assign mothers to nine sessions over 3 months of either IPT-MOMS (N=105) or brief supportive psychotherapy (BSP; N=105), and evaluate the impact of acute maternal treatment on child and maternal outcomes at 3, 6, 9, and 12 month follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interpersonal Psychotherapy for Mothers | Experimental | Interventions will be administered during the 3 Month Acute Randomized Phase and will consist of nine individual 45-minute sessions conducted over the course of three months. Treatment cannot exceed nine sessions. In addition to standard IPT techniques, IPT-MOMS includes a specific focus on the challenges associated with managing a child who suffers from psychiatric problems. |
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| Brief Supportive Psychotherapy | Active Comparator | Interventions will be administered during the 3 Month Acute Randomized Phase and will consist of nine individual 45-minute sessions conducted over the course of three months. Treatment cannot exceed 9 sessions. Brief supportive therapy (BSP) is a manualized form of supportive psychotherapy which emphasizes reflective listening and elicitation of affect (Markowitz et al., 2008). Therapists are instructed to allow patients to determine the focus of each session, pulling for emotion, validating emotions when possible, and offering empathic comments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interpersonal Psychotherapy for Mothers (IPT-MOMS) | Behavioral | Interventions will be administered during the 3 Month Acute Randomized Phase and will consist of nine individual 45-minute sessions conducted over the course of three months. Treatment cannot exceed nine sessions. In addition to standard IPT techniques, IPT-MOMS includes a specific focus on the challenges associated with managing a child who suffers from psychiatric problems. |
| Measure | Description | Time Frame |
|---|---|---|
| We will compare the effects of two interventions IPT-MOMS and BSP on children outcomes: depressive symptoms (as measured by the CDI), total difficulties (as measured by the SDQ), and psychosocial functioning (as measured by the CIS) over time | Baseline, Months 3, 6, 9, 12 | |
| We will compare the two groups in depressive symptoms (as measured by the HRSD-25) and psychosocial and vocational functioning (as measured by the IIP, ISEL, and WSAS) over time. | Baseline, Months 3, 6, 9, 12 |
| Measure | Description | Time Frame |
|---|---|---|
| We will look at major depressive episode criteria for all mothers | 3, 6, 9, and 12 months |
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Inclusion Criteria:
Inclusion Criteria (Mothers)
Inclusion Criteria (Psychiatrically Ill Children)
Exclusion Criteria:
Exclusion Criteria (Mothers)
If a mother subject IS NOT on antidepressants:
Mothers must be off all antidepressant medications for at least 14 days (30 days for fluoxetine) prior to screening to ensure that pretreatment assessments are not distorted by drug withdrawal or rebound effects). Mother subjects cannot start taking antidepressant medications during the acute treatment phase. If they do start taking antidepressant medication during the acute treatment portion of the study, their participation in the acute phase of the study will be terminated. They will be continued to be followed in the follow-up phase.
If a mother subject IS on antidepressants:
Mothers must be on a stable dose of an antidepressant medication (4 consecutive weeks at the same dose) prior to signing consent. The mother subject must agree to stay on the same antidepressant at this current dose throughout the duration of the acute phase of the study. If a participant's dosage of an antidepressant medication is changed or if they cease taking their antidepressant medication during the acute treatment portion of the study, their participation in the acute phase of the study will be terminated. They will be continued to be followed in the follow-up phase.
Active suicidal ideation or homicidal ideation that in the clinical opinion of the research team as headed by the PI, would require hospitalization
At serious risk for child abuse or neglect which in the clinical opinion of the research team as headed by the PI, requires intervention
Comorbid psychotic disorder, organic mental disorder, current (within prior six months) substance or alcohol abuse, borderline personality disorder, antisocial personality disorder, or history of a prior manic episode (bipolar disorder)
Significant medical illness that might explain depressive symptoms such as epilepsy, autoimmune disorders, or unstable endocrine disease
Not fluent in English. The intervention to be tested in this study is psychotherapy. The staff is only trained to deliver these interventions in English. Thus, all subjects must be fluent in English.
Severe cognitive deficits that would preclude treatment with psychotherapy and/or prevent completion of study questionnaires
Current receipt of another form of individual psychotherapy; concurrent participation in a support group (such as Alcoholics Anonymous), couples therapy, or family therapy will be permitted
Currently in an abusive relationship as determined by the domestic violence questionnaire and/or PI's judgment
Unwilling or unable to comply with study requirements (i.e., complete forms, attend scheduled evaluations)
Exclusion Criteria (Psychiatrically Ill Children)
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| Name | Affiliation | Role |
|---|---|---|
| Holly Swartz, M.D. | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27238068 | Derived | Swartz HA, Cyranowski JM, Cheng Y, Zuckoff A, Brent DA, Markowitz JC, Martin S, Amole MC, Ritchey F, Frank E. Brief Psychotherapy for Maternal Depression: Impact on Mothers and Children. J Am Acad Child Adolesc Psychiatry. 2016 Jun;55(6):495-503.e2. doi: 10.1016/j.jaac.2016.04.003. Epub 2016 Apr 7. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000079062 | Interpersonal Psychotherapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Brief Supportive Psychotherapy | Behavioral | Interventions will be administered during the 3 Month Acute Randomized Phase and will consist of nine individual 45-minute sessions conducted over the course of three months. Treatment cannot exceed 9 sessions. Brief supportive therapy (BSP) is a manualized form of supportive psychotherapy which emphasizes reflective listening and elicitation of affect (Markowitz et al., 2008). Therapists are instructed to allow patients to determine the focus of each session, pulling for emotion, validating emotions when possible, and offering empathic comments. |
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