DepressionPhase 1NCT00904917

Preventing Depression in the Children of Depressed African American Mothers

A Phase 1 study testing Prevention Intervention Project and Psychoeducation in people with Depression, run by Children's Hospital of Philadelphia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 8 to 14 years
Conditions the study is for: Depression
What is being tested?: Prevention Intervention Project and Psychoeducation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteUnited States
Study dates: Feb 2008to Feb 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 14 years
All sexes
No healthy volunteers
Child

Who may be able to join

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
Have an African American mother with a depressive disorder
8 to 14 years old
Reside at least part time with mother

Who cannot join

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

Show all 9Show fewer

Children:
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

Trial locations and contacts

1 site in 1 country.

United States1 site

The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Children of Depressed Mothers: Culture & Prevention

The purpose of the study is to adapt and test the Preventive Intervention Project for urban African American mothers with depression and their children.

Read the 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.

Conditions: Depression
Being tested: Prevention Intervention Project, Psychoeducation
Keywords: African American Mothers, Children, African American Families, Parental Depression, Preventive Intervention
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prevention Intervention ProjectBehavioural
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.
PsychoeducationBehavioural
Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family.

Study groups in NCT00904917
Study group	Role	What they receive
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. Receives: Behavioral: Prevention Intervention Project
Lecture	Active comparator	Mothers received psychoeducation about depression. The intervention was psychoeducation. Receives: Behavioral: Psychoeducation

What is being measured

The primary outcome is the main question the study is designed to answer.

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: 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: Measured at baseline and post-treatment (8 weeks after baseline)

Secondary outcomes (2)

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.
Measured: 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: Measured at baseline and post-treatment (8 weeks after baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Feb 2009

First posted20 May 2009 (estimated)
Study startFeb 2008
Primary completionFeb 2009
Study completionFeb 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00904917
Sponsor's protocol ID: 2004-10-4041
Other IDs: K01MH068619, DSIR 8K-RTCT, IRB NO: 2004-10-4041
Status last verified: Oct 2014
First submitted: 19 May 2009
Last updated: 20 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety

All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Children of Depressed Mothers: Culture & Prevention
ClinicalTrials.gov ID: NCT00904917
Acronym / sponsor ID: 2004-10-4041
Conditions: Depression
Keywords: African American Mothers, Children, African American Families, Parental Depression, Preventive Intervention
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Children's Hospital of PhiladelphiaUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Feb 2008
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 20 May 2009 (estimated)
Results: Posted 20 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Adapted PIP	Experimental	Behavioral: Prevention Intervention ProjectParticipants (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	Behavioral: PsychoeducationMothers received psychoeducation about depression. The intervention was psychoeducation.

Who may qualify

Ages: 8 to 14 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Prevention Intervention ProjectEight 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.	Behavioural	Adapted PIP
PsychoeducationTwo 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family.	Behavioural	Lecture

Primary outcome

Children Depression Inventory (CDI)
Time frame: 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)
Time frame: 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.

2 secondary outcomes

Understanding Mood Disorders Questionnaire (UMDQ)
Time frame: Measured at baseline and post-treatment (8 weeks after baseline)
Child's Report on Parental Behavior Inventory (CRPBI)
Time frame: Measured at baseline and post-treatment (8 weeks after baseline)

Results and safety

Results posted to the registry on 20 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adapted PIP (Mothers)	7	5
Adapted PIP (Children)	11	9
Lecture (Mothers)	8	6
Lecture (Children)	8	6

Primary outcome: Children Depression Inventory (CDI)

Time frame: Measured at baseline and at post-treatment (8 weeks after baseline). Mean (Standard Deviation). Unit: T scores

Measure	Adapted PIP n = 11	Lecture n = 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)

Adapted PIP vs Lecture: p = .015, t-test, 2 sided

Population analysed: 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).

Primary outcome: Multidimensional Anxiety Scale for Children (MASC)

Time frame: Measured at baseline and post-treatment (8 weeks after baseline). Mean (Standard Deviation). Unit: T scores

Measure	Adapted PIP n = 11	Lecture n = 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)

Population analysed: 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).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event was collected for 1 year.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adapted PIP	0 of 18 (0%)	0 of 18 (0%)	Not reported
Lecture	0 of 16 (0%)	0 of 16 (0%)	Not reported

Limitations and caveats (from the sponsor): Small sample size; Inadequate power to detect changes between groups; No-intervention comparison group; Differential attrition in the two groups favoring the comparison group

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Depression

Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rhonda C. Boyd, PhD principal investigator

Children's Hospital of Philadelphia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Prevention Intervention Project and Psychoeducation in people with Depression, run by Children's Hospital of Philadelphia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Children Depression Inventory (CDI) (time frame: Measured at baseline and at post-treatment (8 weeks after baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00904917.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2014.