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| ID | Type | Description | Link |
|---|---|---|---|
| K01MH068619 | U.S. NIH Grant/Contract | View source | |
| DSIR 8K-RTCT | Other Identifier | NIMH DSIR | |
| IRB NO: 2004-10-4041 | Other Identifier | IRB No. |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of the study is to adapt and test the Preventive Intervention Project for urban African American mothers with depression and their children.
Abstract
Background: There is limited representation of ethnic minorities in preventive interventions for the generational impact of maternal depression.
Methods: The Preventive Intervention Project (PIP) was adapted to be culturally and contextually relevant for urban African American mothers with depression and their children. A pilot clinical trial (PIP vs. lecture) was conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adapted PIP | Experimental | Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother. The intervention was the Prevention Intervention Project. |
|
| Lecture | Active Comparator | Mothers received psychoeducation about depression. The intervention was psychoeducation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevention Intervention Project | Behavioral | Eight 1-hour sessions focused on psychoeducation, coping with stress, and cognitive-behavioral strategies. The sessions were tailored as required to meet the clinical and cultural needs of each family; other family members, such as fathers, spouses, and grandparents, were invited to participate in the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Children Depression Inventory (CDI) | Children Depression Inventory (CDI; Kovacs, 1992) is a widely-used self-report scale of depressive symptoms suitable for use by youth ranging from 7 to 17 years. The CDI is a 27-item scale that is self-rated and symptom-oriented. The 27 items on the assessment are grouped into five major factor areas. The item score are rated 0-2 with a total scores summed and converted to T scores. The total T score ranges from 33 to 100 with high scores indicating higher levels of depressive symptoms. | Measured at baseline and at post-treatment (8 weeks after baseline) |
| Multidimensional Anxiety Scale for Children (MASC) | Multidimensional Anxiety Scale for Children (MASC; March et al., 1997) is a self-report instrument that measures a broad range of anxiety symptoms in youth. The MASC consists of 39 items using a 4-point Likert scale that are distributed across four major factors, three of which can be parsed into two subfactors each. Main and subfactors include (1) physical symptoms (tense/restless and somatic/autonomic), (2) social anxiety (humiliation/rejection and public performance fears), (3) harm avoidance (perfectionism and anxious coping), and (4) separation anxiety. Scores are summed and converted to T-scores. The total T score ranges from 25 to 90 with higher scores representing greater levels of anxiety. | Measured at baseline and post-treatment (8 weeks after baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Understanding Mood Disorders Questionnaire (UMDQ) | Understanding Mood Disorders Questionnaire (UMDQ; Gavazzi, Fristad, & Law, 1997) measures attributions and knowledge of symptoms, course, and treatment of mood disorders and a symptom checklist. It has 39 items and two subscales. A range of total score is 0 to 59. The first 20 questions are true/false questions and correct responses are scored 2 points each. Nineteen questions are a checklist of symptoms and correct identification of those depression and manic symptoms are scored 1 point each. All items are summed for a total score. Higher scores indicate greater knowledge of mood disorders. Both maternal and child reporters completed this measure. |
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Mothers:
Inclusion Criteria:
Exclusion Criteria:
Children:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rhonda C. Boyd, PhD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
Eighteen mothers completed the Structured Clinical Interview (SCID), with 16 being eligible to participate in the study, and 1 mother did not complete the baseline interview. Fifteen mothers (with 19 children) were randomized.
The majority of the mothers were recruited through newspaper ads while remaining participants were recruited from word of mouth, research studies, mental health clinics and other sources.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adapted PIP (Mothers) | Mothers participated in an adapted PIP for the families of children with a depressed African American mother. Prevention Intervention Project : Eight 1-hour sessions, tailored as required to meet the clinical and cultural needs of each family. Intervention focuses on education, coping with stress, and cognitive-behavioral strategies. |
| FG001 | Adapted PIP (Children) | Children of the mother-child dyad in the adapted PIP intervention for families of children with a depressed African American Mother. Intervention Project: Eight 1 hour sessions, tailored as required to meet the clinical and cultural needs of each family. Intervention focuses on education, coping with stress, and cognitive-behavioral strategies |
| FG002 | Lecture (Mothers) | Mothers who received education about depression. Psychoeducation : Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family. |
| FG003 | Lecture (Children) | Children of mothers who received education about depression. Psychoeducation : Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The participant flow module is based on the number of mother-child dyads that completed the baseline assessment(s), while the overall number of participants is based on the number of mothers and children in the intervention and control groups.
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| ID | Title | Description |
|---|---|---|
| BG000 | Adapted PIP (Mothers) | Mothers of the mother-child dyad in the adapted PIP intervention. |
| BG001 | Adapted PIP (Children) | Children of the mother-child dyad in the adapted PIP intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Children Depression Inventory (CDI) | Children Depression Inventory (CDI; Kovacs, 1992) is a widely-used self-report scale of depressive symptoms suitable for use by youth ranging from 7 to 17 years. The CDI is a 27-item scale that is self-rated and symptom-oriented. The 27 items on the assessment are grouped into five major factor areas. The item score are rated 0-2 with a total scores summed and converted to T scores. The total T score ranges from 33 to 100 with high scores indicating higher levels of depressive symptoms. | These scores are based on the CDI which was administered solely to the children of the dyadic mother-child intervention and control groups. Post-intervention scores based on 9 children in Adapted PIP (2 lost to follow-up) and 6 children in Lecture group (2 lost to follow-up). | Posted | Mean | Standard Deviation | T scores | Measured at baseline and at post-treatment (8 weeks after baseline) |
|
Adverse event was collected for 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adapted PIP | Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother. The intervention was the Preventive Intervention Project. |
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Small sample size; Inadequate power to detect changes between groups; No-intervention comparison group; Differential attrition in the two groups favoring the comparison group
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rhonda C. Boyd, Ph.D. | Children's Hospital of Philadelphia | 215-590-3945 | boydr@email.chop.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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|
| Psychoeducation | Behavioral | Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family. |
|
| Measured at baseline and post-treatment (8 weeks after baseline) |
| Child's Report on Parental Behavior Inventory (CRPBI) | Child's Report on Parental Behavior Inventory (CRPBI; Schludermann & Schludermann, 1970) assesses children's and parents' perceptions of parental acceptance, permitting psychological autonomy, and level of parental control. The 10-item acceptance scale which assesses parental warmth was administered. The acceptable scale has items scored from 1 to 3 (not like me, somewhat like me, a lot like me). Items are summed with a total range is 10 to 30. Higher scores represents greater warmth exhibited by mother to child. Separate forms are available for both child and parent report. | Measured at baseline and post-treatment (8 weeks after baseline) |
| BG002 | Lecture (Mothers) | Mothers of the mother-child dyad in the lecture control group. |
| BG003 | Lecture (Children) | Children of the mother-child dyad in the lecture control group. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother.
The intervention was the Prevention Intervention Project.
| OG001 | Lecture | Mothers received psychoeducation about depression. The intervention was psychoeducation. |
|
|
|
| Primary | Multidimensional Anxiety Scale for Children (MASC) | Multidimensional Anxiety Scale for Children (MASC; March et al., 1997) is a self-report instrument that measures a broad range of anxiety symptoms in youth. The MASC consists of 39 items using a 4-point Likert scale that are distributed across four major factors, three of which can be parsed into two subfactors each. Main and subfactors include (1) physical symptoms (tense/restless and somatic/autonomic), (2) social anxiety (humiliation/rejection and public performance fears), (3) harm avoidance (perfectionism and anxious coping), and (4) separation anxiety. Scores are summed and converted to T-scores. The total T score ranges from 25 to 90 with higher scores representing greater levels of anxiety. | These scores are based on the MASC which was administered solely to the children of the dyadic mother-child intervention and control groups. Post-intervention scores based on 9 children in Adapted PIP (2 lost to follow-up) and 6 children in Lecture group (2 lost to follow-up). | Posted | Mean | Standard Deviation | T scores | Measured at baseline and post-treatment (8 weeks after baseline) |
|
|
|
| Secondary | Understanding Mood Disorders Questionnaire (UMDQ) | Understanding Mood Disorders Questionnaire (UMDQ; Gavazzi, Fristad, & Law, 1997) measures attributions and knowledge of symptoms, course, and treatment of mood disorders and a symptom checklist. It has 39 items and two subscales. A range of total score is 0 to 59. The first 20 questions are true/false questions and correct responses are scored 2 points each. Nineteen questions are a checklist of symptoms and correct identification of those depression and manic symptoms are scored 1 point each. All items are summed for a total score. Higher scores indicate greater knowledge of mood disorders. Both maternal and child reporters completed this measure. | These scores are based on the UMDQ, which was administered to both the mothers and their children of the dyadic mother-child intervention and control groups. Post-intervention scores based on 5 mothers and 9 children in Adapted PIP (4 participants lost to follow-up) and 6 mothers and 6 children in Lecture group (4 participants lost to follow-up). | Posted | Mean | Standard Deviation | units on a scale | Measured at baseline and post-treatment (8 weeks after baseline) |
|
|
|
|
| Secondary | Child's Report on Parental Behavior Inventory (CRPBI) | Child's Report on Parental Behavior Inventory (CRPBI; Schludermann & Schludermann, 1970) assesses children's and parents' perceptions of parental acceptance, permitting psychological autonomy, and level of parental control. The 10-item acceptance scale which assesses parental warmth was administered. The acceptable scale has items scored from 1 to 3 (not like me, somewhat like me, a lot like me). Items are summed with a total range is 10 to 30. Higher scores represents greater warmth exhibited by mother to child. Separate forms are available for both child and parent report. | These scores are based on the CRPBI, which was administered to both the mothers and their children of the dyadic mother-child intervention and control groups. Post-intervention scores based on 5 mothers and 9 children in Adapted PIP (4 participants lost to follow-up) and 6 mothers and 6 children in Lecture group (4 participants lost to follow-up). | Posted | Mean | Standard Deviation | units on a scale | Measured at baseline and post-treatment (8 weeks after baseline) |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Lecture | Mothers received psychoeducation about depression. | 0 | 16 | 0 | 16 |
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| Post-intervention scores (8 weeks from baseline) |
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| Post-intervention scores (8 weeks from baseline) |
|