Preventing Depression in the Children of Depressed African American Mothers

• Sponsor: Children's Hospital of Philadelphia (Other)
• Overall Status: Completed
• CT.gov ID: NCT00904917
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 34
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Behavioral: Prevention Intervention Project; Behavioral: Psychoeducation	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Children of Depressed Mothers: Culture & Prevention
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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 Prevention Intervention Project.	Behavioral: Prevention 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.
Active Comparator: Lecture Mothers received psychoeducation about depression. The intervention was psychoeducation.	Behavioral: Psychoeducation; Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Exclusion Criteria:

• Currently in treatment for depression or an anxiety disorder

• Presence of a medical or psychiatric condition contraindicating study intervention, such as mental retardation, suicidality, or pervasive developmental disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Children's Hospital of Philadelphia
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Rhonda C. Boyd, PhD, Children's Hospital of Philadelphia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rhonda Boyd, Associate Professor, Children's Hospital of Philadelphia
• ClinicalTrials.gov Identifier: NCT00904917
• Other Study ID Numbers: 2004-10-4041; K01MH068619; DSIR 8K-RTCT; IRB NO: 2004-10-4041
• First Posted: May 20, 2009
• Last Update Posted: Oct 20, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by Rhonda Boyd, Associate Professor, Children's Hospital of Philadelphia: African American Mothers; Children; African American Families; Parental Depression; Preventive Intervention
• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

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 Detail	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.

Arm/Group Title	Adapted PIP (Mothers)	Adapted PIP (Children)	Lecture (Mothers)	Lecture (Children)
Arm/Group Description	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.	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	Mothers who received education about depression. Psychoeducation : Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family.	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.
Period Title: Overall Study
STARTED	7	11	8	8
COMPLETED	5	9	6	6
NOT COMPLETED	2	2	2	2

Baseline Characteristics

Arm/Group Title	Adapted PIP (Mothers)	Adapted PIP (Children)	Lecture (Mothers)	Lecture (Children)	Total
Arm/Group Description	Mothers of the mother-child dyad in the adapted PIP intervention.	Children of the mother-child dyad in the adapted PIP intervention.	Mothers of the mother-child dyad in the lecture control group.	Children of the mother-child dyad in the lecture control group.	Total of all reporting groups
Overall Participants	7	11	8	8	34
Age (Count of Participants)
<=18 years	0 0%	11 100%	0 0%	8 100%	19 55.9%
Between 18 and 65 years	7 100%	0 0%	8 100%	0 0%	15 44.1%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	7 100%	6 54.5%	8 100%	8 100%	29 85.3%
Male	0 0%	5 45.5%	0 0%	0 0%	5 14.7%
Region of Enrollment (participants) [Number]
United States	7 100%	11 100%	8 100%	8 100%	34 100%

Outcome Measures

1. Primary Outcome

Title	Children Depression Inventory (CDI)
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Adapted PIP	Lecture
Arm/Group Description	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.	Mothers received psychoeducation about depression. The intervention was psychoeducation.
Measure Participants	11	8
Baseline scores	47.64 (8.36)	47.00 (8.55)
Post-intervention scores (8 weeks from baseline)	42.11 (2.98)	43.83 (5.27)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adapted PIP, Lecture
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.015
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Multidimensional Anxiety Scale for Children (MASC)
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Adapted PIP	Lecture
Arm/Group Description	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.	Mothers received psychoeducation about depression. The intervention was psychoeducation.
Measure Participants	11	8
Baseline scores	50.64 (8.43)	52.50 (10.07)
Post-intervention scores (8 weeks from baseline)	43.67 (15.12)	57.67 (32.36)

3. Secondary Outcome

Title	Understanding Mood Disorders Questionnaire (UMDQ)
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Adapted PIP (Mother)	Adapted PIP (Child)	Lecture (Mother)	Lecture (Child)
Arm/Group Description	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.	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.	Mothers received psychoeducation about depression.	Mothers received psychoeducation about depression. The intervention was psychoeducation.
Measure Participants	7	10	8	8
Baseline scores	23.86 (3.93)	14.70 (5.72)	24.25 (3.41)	13.13 (5.57)
Post-intervention scores (8 weeks from baseline)	22.80 (2.59)	14.67 (5.45)	25.00 (2.10)	14.33 (4.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lecture, Lecture (Child)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.037
	Comments
	Method	Regression, Linear
	Comments

4. Secondary Outcome

Title	Child's Report on Parental Behavior Inventory (CRPBI)
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Adapted PIP (Mother)	Adapted PIP (Child)	Lecture (Mother)	Lecture (Child)
Arm/Group Description	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.	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.	Mothers received psychoeducation about depression. The intervention was psychoeducation.	Mothers received psychoeducation about depression. The intervention was psychoeducation.
Measure Participants	7	11	8	8
Baseline scores	25.57 (3.21)	24.55 (4.63)	24.88 (4.09)	27.13 (2.17)
Post-intervention scores (8 weeks from baseline)	26.40 (3.36)	24.67 (3.46)	25.33 (4.68)	25.00 (4.98)

Adverse Events

Time Frame	Adverse event was collected for 1 year.
Arm/Group Title	Adapted PIP		Lecture
Arm/Group Description	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.		Mothers received psychoeducation about depression.
All Cause Mortality
	Adapted PIP		Lecture
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Adapted PIP		Lecture
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Adapted PIP		Lecture
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/16 (0%)

Limitations/Caveats

Small sample size; Inadequate power to detect changes between groups; No-intervention comparison group; Differential attrition in the two groups favoring the comparison group

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.