Depression
Conditions
Keywords
African American Mothers, Children, African American Families, Parental Depression, Preventive Intervention
Brief summary
The purpose of the study is to adapt and test the Preventive Intervention Project for urban African American mothers with depression and their children.
Detailed description
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.
Interventions
BEHAVIORALPrevention Intervention Project
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.
BEHAVIORALPsychoeducation
Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family.
Sponsors
National Institute of Mental Health (NIMH)
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
Mothers: Inclusion Criteria: * African American * Primary current or past-year diagnostic and statistical manual (DSM-IV) diagnosis of Major Depressive Disorder, Dysthymic Disorder, or Depressive Disorder not otherwise specified * Parent or guardian and primary caregiver of a child 8 to 14 years old * Resided at least part time for the past year with the targeted child * May be receiving psychopharmacological treatment, psychosocial services, or both
Exclusion criteria
* Current or lifetime history of schizophrenia * Current or lifetime history of bipolar disorder * Current or past-year diagnosis of alcohol or drug dependency * Serious medical disorder, neurological disorder, condition, or chronic pain that prevents participation * Documented mental retardation * Current suicide risk sufficient to preclude outpatient treatment Children: Inclusion Criteria: * Have an African American mother with a depressive disorder * 8 to 14 years old * Reside at least part time with mother
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Children Depression Inventory (CDI) | Measured at baseline and at post-treatment (8 weeks after baseline) | 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. |
| Multidimensional Anxiety Scale for Children (MASC) | Measured at baseline and post-treatment (8 weeks after baseline) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Understanding Mood Disorders Questionnaire (UMDQ) | Measured at baseline and post-treatment (8 weeks after baseline) | 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. |
| Child's Report on Parental Behavior Inventory (CRPBI) | Measured at baseline and post-treatment (8 weeks after baseline) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Adapted PIP (Mothers) Mothers of the mother-child dyad in the adapted PIP intervention. | 7 |
| Adapted PIP (Children) Children of the mother-child dyad in the adapted PIP intervention. | 11 |
| Lecture (Mothers) Mothers of the mother-child dyad in the lecture control group. | 8 |
| Lecture (Children) Children of the mother-child dyad in the lecture control group. | 8 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 | 2 | 2 |
Baseline characteristics
| Characteristic | Adapted PIP (Mothers) | Adapted PIP (Children) | Lecture (Mothers) | Lecture (Children) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 11 Participants | 0 Participants | 8 Participants | 19 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 0 Participants | 8 Participants | 0 Participants | 15 Participants |
| Region of Enrollment United States | 7 participants | 11 participants | 8 participants | 8 participants | 34 participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 8 Participants | 8 Participants | 29 Participants |
| Sex: Female, Male Male | 0 Participants | 5 Participants | 0 Participants | 0 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 16 |
| serious Total, serious adverse events | 0 / 18 | 0 / 16 |
Outcome results
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.
Time frame: Measured at baseline and at post-treatment (8 weeks after baseline)
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adapted PIP | Children Depression Inventory (CDI) | Baseline scores | 47.64 T scores | Standard Deviation 8.36 |
| Adapted PIP | Children Depression Inventory (CDI) | Post-intervention scores (8 weeks from baseline) | 42.11 T scores | Standard Deviation 2.98 |
| Lecture | Children Depression Inventory (CDI) | Baseline scores | 47.00 T scores | Standard Deviation 8.55 |
| Lecture | Children Depression Inventory (CDI) | Post-intervention scores (8 weeks from baseline) | 43.83 T scores | Standard Deviation 5.27 |
p-value: 0.015t-test, 2 sided
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.
Time frame: Measured at baseline and post-treatment (8 weeks after baseline)
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adapted PIP | Multidimensional Anxiety Scale for Children (MASC) | Baseline scores | 50.64 T scores | Standard Deviation 8.43 |
| Adapted PIP | Multidimensional Anxiety Scale for Children (MASC) | Post-intervention scores (8 weeks from baseline) | 43.67 T scores | Standard Deviation 15.12 |
| Lecture | Multidimensional Anxiety Scale for Children (MASC) | Baseline scores | 52.50 T scores | Standard Deviation 10.07 |
| Lecture | Multidimensional Anxiety Scale for Children (MASC) | Post-intervention scores (8 weeks from baseline) | 57.67 T scores | Standard Deviation 32.36 |
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.
Time frame: Measured at baseline and post-treatment (8 weeks after baseline)
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adapted PIP | Child's Report on Parental Behavior Inventory (CRPBI) | Baseline scores | 25.57 units on a scale | Standard Deviation 3.21 |
| Adapted PIP | Child's Report on Parental Behavior Inventory (CRPBI) | Post-intervention scores (8 weeks from baseline) | 26.40 units on a scale | Standard Deviation 3.36 |
| Lecture | Child's Report on Parental Behavior Inventory (CRPBI) | Post-intervention scores (8 weeks from baseline) | 24.67 units on a scale | Standard Deviation 3.46 |
| Lecture | Child's Report on Parental Behavior Inventory (CRPBI) | Baseline scores | 24.55 units on a scale | Standard Deviation 4.63 |
| Lecture (Mother) | Child's Report on Parental Behavior Inventory (CRPBI) | Baseline scores | 24.88 units on a scale | Standard Deviation 4.09 |
| Lecture (Mother) | Child's Report on Parental Behavior Inventory (CRPBI) | Post-intervention scores (8 weeks from baseline) | 25.33 units on a scale | Standard Deviation 4.68 |
| Lecture (Child) | Child's Report on Parental Behavior Inventory (CRPBI) | Baseline scores | 27.13 units on a scale | Standard Deviation 2.17 |
| Lecture (Child) | Child's Report on Parental Behavior Inventory (CRPBI) | Post-intervention scores (8 weeks from baseline) | 25.00 units on a scale | Standard Deviation 4.98 |
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.
Time frame: Measured at baseline and post-treatment (8 weeks after baseline)
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adapted PIP | Understanding Mood Disorders Questionnaire (UMDQ) | Baseline scores | 23.86 units on a scale | Standard Deviation 3.93 |
| Adapted PIP | Understanding Mood Disorders Questionnaire (UMDQ) | Post-intervention scores (8 weeks from baseline) | 22.80 units on a scale | Standard Deviation 2.59 |
| Lecture | Understanding Mood Disorders Questionnaire (UMDQ) | Post-intervention scores (8 weeks from baseline) | 14.67 units on a scale | Standard Deviation 5.45 |
| Lecture | Understanding Mood Disorders Questionnaire (UMDQ) | Baseline scores | 14.70 units on a scale | Standard Deviation 5.72 |
| Lecture (Mother) | Understanding Mood Disorders Questionnaire (UMDQ) | Baseline scores | 24.25 units on a scale | Standard Deviation 3.41 |
| Lecture (Mother) | Understanding Mood Disorders Questionnaire (UMDQ) | Post-intervention scores (8 weeks from baseline) | 25.00 units on a scale | Standard Deviation 2.1 |
| Lecture (Child) | Understanding Mood Disorders Questionnaire (UMDQ) | Baseline scores | 13.13 units on a scale | Standard Deviation 5.57 |
| Lecture (Child) | Understanding Mood Disorders Questionnaire (UMDQ) | Post-intervention scores (8 weeks from baseline) | 14.33 units on a scale | Standard Deviation 4.18 |
p-value: 0.037Regression, Linear