DepressionPhase 1NCT00183365
Effect of Family-Based Prevention on Children of Depressed Parents
A Phase 1 study testing Parent Skills Training and Protecting Families Program (PFP) in people with Depression, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This study will test the Protecting Families Program, a 10-week prevention program for depressed parents and their pre-teenage children, by comparing the effectiveness of the program versus parent training alone. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Parent Skills Training and Protecting Families Program (PFP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Nov 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parent is currently in treatment
- Parent's primary DSM-IV diagnosis is major depressive disorder, dysthymia, or depression not otherwise specified
- Parent's child lives with him/her at least part time
Who cannot join
- Parent has a history or current diagnosis of any psychotic disorder or organic brain syndrome
- Parent has history of bipolar or schizoaffective disorder
- Parent's IQ is below 70
- Parent has any serious medical or neurological disorder or condition that may prevent weekly participation
- Parent has chronic pain that may prevent weekly participation
- Parent or child is currently suicidal to the extent that it will interfere with outpatient treatment
Show all 10Show fewer
- Parent has a current substance dependence
- Child is currently seeking psychological treatment
- Child is mentally retarded (determined by school and clinic records)
- Child has a clinically severe psychiatric diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Family Intervention Science; The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Children of Depressed Parents: Family-Based Prevention
This study will test the Protecting Families Program, a 10-week prevention program for depressed parents and their pre-teenage children, by comparing the effectiveness of the program versus parent training alone.
Read the detailed description
Children of depressed parents are at risk for developing social-emotional problems. Despite the fact that economic hardship is a strong risk factor for both maternal depression and poor child development, little research has been conducted to develop prevention programs for low-income urban families. This randomized, open-label study will address the research gap by developing and pilot-testing the Protecting Families Program (PFP), a family-based, multi-component prevention program. The PFP will offer its services to low-income, urban, depressed parents and their children between the ages of 9 and 14.
Prior to the interventional portion of the study, several small focus groups composed of mental-health care providers and depressed parents will meet. The purpose of these focus groups will be to gather information that will help maximize the effectiveness of the remainder of the study. The interventional phase will compare PFP combined with individual parent training versus parent training alone. Participants will be randomly assigned to one of these two intervention groups. The study will last a total of 10 weeks. Both groups will meet once each week. PFP will include a community meal at the beginning of each session, a parent skills training group, and a concurrent cognitive behavioral therapy (CBT) group for the focal child. Participants' symptoms, diagnosis, functional status, family functioning, cognitive factors, and parenting practices will be assessed at the study start date, immediately post-intervention, and 6 months post-intervention.
- Conditions
- Depression
- Being tested
- Parent Skills Training, Protecting Families Program (PFP)
- Keywords
- Family, Parenting, Depression, Group Intervention
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Skills TrainingBehavioural
Parent skills training will include 10 weeks of psychoeducational and skills training group sessions for parents.
Protecting Families Program (PFP)Behavioural
Participants will receive 10 weeks of PFP, which will include a community meal at the beginning of each session, a parent skills training group, and a concurrent cognitive behavioral therapy (CBT) group for the focal child.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive the Protecting Families Program with individual parent training Receives: Behavioral: Parent Skills Training; Behavioral: Protecting Families Program (PFP) |
| 2 | Active comparator | Participants will receive parent training alone Receives: Behavioral: Parent Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child psychiatric symptomology
Measured: Measured immediately post-treatment and at 6-month follow-up
Secondary outcomes (1)
Parenting skills, family functioning, and parent social support
Measured: Measured immediately post-treatment and at 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startOct 2005
- Primary completionJul 2008
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Guy Diamond, PhD, Principal investigator, University of Pennsylvania / CHOPRhonda Boyd, PhD, Principal investigator, University of Pennsylvania / CHOP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183365
- Sponsor's protocol ID
- 2004-8-3934
- Other IDs
- R34MH071868, DDTR B4-ARD
- Status last verified
- Feb 2014
- First submitted
- 12 Sep 2005
- Last updated
- 9 Jan 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children of Depressed Parents: Family-Based Prevention
- ClinicalTrials.gov ID
- NCT00183365
- Acronym / sponsor ID
- 2004-8-3934
- Conditions
- Depression
- Keywords
- Family, Parenting, Depression, Group Intervention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the Protecting Families Program, a 10-week prevention program for depressed parents and their pre-teenage children, by comparing the effectiveness of the program versus parent training alone.
Detailed description
Children of depressed parents are at risk for developing social-emotional problems. Despite the fact that economic hardship is a strong risk factor for both maternal depression and poor child development, little research has been conducted to develop prevention programs for low-income urban families. This randomized, open-label study will address the research gap by developing and pilot-testing the Protecting Families Program (PFP), a family-based, multi-component prevention program. The PFP will offer its services to low-income, urban, depressed parents and their children between the ages of 9 and 14.
Prior to the interventional portion of the study, several small focus groups composed of mental-health care providers and depressed parents will meet. The purpose of these focus groups will be to gather information that will help maximize the effectiveness of the remainder of the study. The interventional phase will compare PFP combined with individual parent training versus parent training alone. Participants will be randomly assigned to one of these two intervention groups. The study will last a total of 10 weeks. Both groups will meet once each week. PFP will include a community meal at the beginning of each session, a parent skills training group, and a concurrent cognitive behavioral therapy (CBT) group for the focal child. Participants' symptoms, diagnosis, functional status, family functioning, cognitive factors, and parenting practices will be assessed at the study start date, immediately post-intervention, and 6 months post-intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Parent Skills Training, Behavioral: Protecting Families Program (PFP)Participants will receive the Protecting Families Program with individual parent training |
| 2 | Active comparator | Behavioral: Parent Skills TrainingParticipants will receive parent training alone |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Parent is currently in treatment
- Parent's primary DSM-IV diagnosis is major depressive disorder, dysthymia, or depression not otherwise specified
- Parent's child lives with him/her at least part time
Key exclusion criteria (10 listed)
- Parent has a history or current diagnosis of any psychotic disorder or organic brain syndrome
- Parent has history of bipolar or schizoaffective disorder
- Parent's IQ is below 70
- Parent has any serious medical or neurological disorder or condition that may prevent weekly participation
- Parent has chronic pain that may prevent weekly participation
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 |
|---|---|---|
| Parent Skills TrainingParent skills training will include 10 weeks of psychoeducational and skills training group sessions for parents. | Behavioural | 1, 2 |
| Protecting Families Program (PFP)Participants will receive 10 weeks of PFP, which will include a community meal at the beginning of each session, a parent skills training group, and a concurrent cognitive behavioral therapy (CBT) group for the focal child. | Behavioural | 1 |
Primary outcome
Child psychiatric symptomology
Time frame: Measured immediately post-treatment and at 6-month follow-up
1 secondary outcome
Parenting skills, family functioning, and parent social support
Time frame: Measured immediately post-treatment and at 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
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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.
Guy Diamond, PhD principal investigator
University of Pennsylvania / CHOP
Rhonda Boyd, PhD principal investigator
University of Pennsylvania / CHOP
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 Parent Skills Training and Protecting Families Program (PFP) 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 3 inclusion and 10 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 9 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Child psychiatric symptomology (time frame: Measured immediately post-treatment and at 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2026.