DepressionEPDCNCT01464619
Enhancing Parenting for Depressed Caregivers
A study testing The Incredible Years Parenting Intervention and Delayed Intervention in people with Depression, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The main objective of this study is to adapt a parenting intervention for caregivers of young children who report depressive symptoms in primary care pediatric practices. In addition, the study will explore the acceptability and feasibility of a validated parenting program. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- The Incredible Years Parenting Intervention and Delayed Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Nov 2013
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A caregiver is eligible to participate in the study if they meet the following entry requirements:
- 18 years of age or older at the start of the study
- Patient Health Questionnaire (PHQ) score of 3 or higher
- Have a child who is between 12 and 30 months at the time of screening
- Legal guardian of the child
- English speaking
- Resides in Philadelphia County
Who cannot join
- Caregiver scores negatively on the Patient Health Questionnaire (PHQ).
- Caregiver does not reside in Philadelphia County.
- Caregiver is under 18 years old.
- Caregiver has a child who is older or younger than 12 to 30 months.
- Caregiver is not the legal guardian of the child.
- Caregiver does not speak English.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
The main objective of this study is to adapt a parenting intervention for caregivers of young children who report depressive symptoms in primary care pediatric practices. In addition, the study will explore the acceptability and feasibility of a validated parenting program.
Read the detailed description
This randomized control study aims to (1) adapt a parenting intervention for depressed caregivers of young children in primary care, (2) assess the acceptability and feasibility of implementing a parenting intervention for depressed caregivers of young children in primary care, and (3)to explore differences in depressive symptoms, parenting stress, parent response to child behaviors, social support, child developmental and behavioral functioning, and completion of mental health referrals among depressed caregivers who receive the intervention or control condition. Two Philadelphia City Health Centers and the five Children's Hospital of Philadelphia (CHOP) Primary Care Practices in Philadelphia, and the Early Head Start site at CHOP will be recruited to participate in the study. Incredible Years Parents, Babies and Toddlers Program, a validated group parenting education program has been adapted for use with depressed caregivers by inclusion of psychoeducational depression materials and by recommendations from a study steering committee composed of parents of young children, behavioral health specialists, and early childhood educators. Caregivers attending their 12-30 month old child's well-child visit at participating practices will complete the Patient Health Questionnaire-2, a brief validated depression screen. Caregivers who screen positive (score>2) for depression treatment will receive mental health resource materials and be invited to participate in the study. Caregivers who enroll in the study will be consented and randomized to receive enhanced mental health referrals and either (1) attend the parenting intervention immediately (immediate intervention) or (2) after participating in the study for three months (wait list control). Parents in both study arms will complete measures of depression severity (Beck Depression Inventory-II), parenting stress (Parenting Stress Index-Short Form), parent response to child behaviors (Parenting Scale), social support (Multidimensional Scale of Perceived Social Support), and child functioning (Infant and Toddler Social and Emotional Assessment [ITSEA] and the Bayley Scales of Infant and Toddler development Screening Tool) at baseline, three-four months, and six-seven month study visits. In addition, parents will be contacted monthly to assess follow through, barriers to and need for assistance with mental health referrals. Information on the feasibility (proportion who enroll in the study and proportion who attend at least one intervention session), and acceptability (proportion who attend 4 or more intervention sessions and overall intervention satisfaction) of this intervention and its measures will be used to design future studies to test effectiveness of parenting interventions for depressed caregivers in pediatric primary care practices. If proven effective, such interventions could be disseminated to other pediatric practices to assist them in caring for depressed caregivers.
In order to better understand the barriers and facilitators to conducting depression screening of parents in primary care practices, we are conducting interviews with clinicians who performed depression screenings as part of the quality improvement initiative to implement depression screenings for caregivers of young children in primary care practices. After assessing clinician responses to the interview questions, we will identify perceptions of parental depression, screening procedures, referral procedures, and barriers and facilitators to screening in primary care and disseminate the results to better inform future depression screening initiatives in the primary care setting.
- Conditions
- Depression
- Being tested
- The Incredible Years Parenting Intervention, Delayed Intervention
- Keywords
- Parenting, Early Child Development
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Incredible Years Parenting InterventionOther
The Incredible Years Parents, Babies, and Toddlers Program is a validated group parenting education program, which has been adapted for use with depressed caregivers by inclusion of psychoeducational depression materials.
Delayed InterventionOther
Caregivers assigned to delayed intervention will be assigned to the Incredible Years parenting intervention 3-4 months after enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Delayed Intervention | Experimental | Those assigned to the delayed intervention arm will receive enhanced mental health referrals, monthly follow-up phone calls, and will be assigned to the parenting intervention 3-4 months after enrollment. Receives: Other: Delayed Intervention |
| Intervention | Experimental | Caregivers assigned to the intervention arm will be assigned to the Incredible Years parenting intervention immediately after enrollment. They will also receive enhanced mental health referrals and monthly follow-up phone calls. Receives: Other: The Incredible Years Parenting Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of a Parent Coaching Intervention
Feasibility of the parent coaching intervention will be assessed by the proportion of participants who attended at least 10 sessions of Incredible Years over 3 months.
Measured: 3 months
Secondary outcomes (7)
Change in Caregiver Depressive Symptoms
Change from baseline to follow-up of the Beck Depression Scale-II (BDI-II), a validated self-report measure of depressive symptoms. The scale range is from 0 to 63 with higher scores indicating worse depressive symptoms.
Measured: 3 months
Acceptability of the Parent Coaching Intervention
Acceptability of the parent coaching intervention will be assessed by a response to the question "How did you like the parenting program?" at the conclusion of the parent sessions. the responses ranged from 1 (highly disliked) to 5 (highly liked)
Measured: 3 months
Attendance at 6 or More Incredible Years (IY) Sessions
Feasibility of the parent coaching intervention will be assessed by the proportion of participants who attended at least 6 sessions of IY.
Measured: 3 months
Feasibility of a Parent Coaching Intervention Incredible Years (IY) That Has Been Adapted for Depressed Caregivers.
Feasibility of the parent coaching intervention will be assessed by the proportion of participants who attended at least 1 session of IY.
Measured: 3 months
Change in Parenting Stress
Change from baseline to follow-up of the Parenting Stress Index-Short Form Total (PSI-SF), a validated self-report measure of parenting stress. Total scores range from 36 to 180 with higher scores indicating greater levels of parenting stress.
Measured: 3 months
Change in Social Support
Change from baseline to follow-up of the Multidimensional Scale of Perceived Social Support (MSPSS), a validated self-report measure of perceived social support from family, friends, and a significant other. Total scores range from 12 to 84 with higher scores indicating greater perceived social support.
Measured: 3 months
Change in Parenting Discipline
Change from baseline to follow-up of the Parenting Scale (PS), a validated self-report measure of parents' self-reported parenting discipline. Total scores range from 1 to 7 with lower scores indicating better parenting discipline.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2012
- Study completionNov 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Pediatrics, HRSA/Maternal and Child Health Bureau
- Responsible party
- Sponsor
- Investigators
- James Guevara, MD, MPH, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464619
- Sponsor's protocol ID
- IRB 09-007271
- Acronym
- EPDC
- Status last verified
- Mar 2016
- First submitted
- 19 Jul 2011
- Last updated
- 11 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Boyd RC, Gerdes M, Rothman B, Dougherty SL, Localio R, Guevara JP. A Toddler Parenting Intervention in Primary Care for Caregivers With Depression Symptoms. J Prim Prev. 2017 Oct;38(5):465-480. doi: 10.1007/s10935-017-0481-8.
PubMed 28733799
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Parenting for Depressed Caregivers
- ClinicalTrials.gov ID
- NCT01464619
- Acronym / sponsor ID
- EPDC / IRB 09-007271
- Conditions
- Depression
- Keywords
- Parenting, Early Child Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- American Academy of Pediatrics, HRSA/Maternal and Child Health Bureau
- Study start
- Jul 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 3 Nov 2011 (estimated)
- Results
- Posted 6 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to adapt a parenting intervention for caregivers of young children who report depressive symptoms in primary care pediatric practices. In addition, the study will explore the acceptability and feasibility of a validated parenting program.
Detailed description
This randomized control study aims to (1) adapt a parenting intervention for depressed caregivers of young children in primary care, (2) assess the acceptability and feasibility of implementing a parenting intervention for depressed caregivers of young children in primary care, and (3)to explore differences in depressive symptoms, parenting stress, parent response to child behaviors, social support, child developmental and behavioral functioning, and completion of mental health referrals among depressed caregivers who receive the intervention or control condition. Two Philadelphia City Health Centers and the five Children's Hospital of Philadelphia (CHOP) Primary Care Practices in Philadelphia, and the Early Head Start site at CHOP will be recruited to participate in the study. Incredible Years Parents, Babies and Toddlers Program, a validated group parenting education program has been adapted for use with depressed caregivers by inclusion of psychoeducational depression materials and by recommendations from a study steering committee composed of parents of young children, behavioral health specialists, and early childhood educators. Caregivers attending their 12-30 month old child's well-child visit at participating practices will complete the Patient Health Questionnaire-2, a brief validated depression screen. Caregivers who screen positive (score>2) for depression treatment will receive mental health resource materials and be invited to participate in the study. Caregivers who enroll in the study will be consented and randomized to receive enhanced mental health referrals and either (1) attend the parenting intervention immediately (immediate intervention) or (2) after participating in the study for three months (wait list control). Parents in both study arms will complete measures of depression severity (Beck Depression Inventory-II), parenting stress (Parenting Stress Index-Short Form), parent response to child behaviors (Parenting Scale), social support (Multidimensional Scale of Perceived Social Support), and child functioning (Infant and Toddler Social and Emotional Assessment [ITSEA] and the Bayley Scales of Infant and Toddler development Screening Tool) at baseline, three-four months, and six-seven month study visits. In addition, parents will be contacted monthly to assess follow through, barriers to and need for assistance with mental health referrals. Information on the feasibility (proportion who enroll in the study and proportion who attend at least one intervention session), and acceptability (proportion who attend 4 or more intervention sessions and overall intervention satisfaction) of this intervention and its measures will be used to design future studies to test effectiveness of parenting interventions for depressed caregivers in pediatric primary care practices. If proven effective, such interventions could be disseminated to other pediatric practices to assist them in caring for depressed caregivers.
In order to better understand the barriers and facilitators to conducting depression screening of parents in primary care practices, we are conducting interviews with clinicians who performed depression screenings as part of the quality improvement initiative to implement depression screenings for caregivers of young children in primary care practices. After assessing clinician responses to the interview questions, we will identify perceptions of parental depression, screening procedures, referral procedures, and barriers and facilitators to screening in primary care and disseminate the results to better inform future depression screening initiatives in the primary care setting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed Intervention | Experimental | Other: Delayed InterventionThose assigned to the delayed intervention arm will receive enhanced mental health referrals, monthly follow-up phone calls, and will be assigned to the parenting intervention 3-4 months after enrollment. |
| Intervention | Experimental | Other: The Incredible Years Parenting InterventionCaregivers assigned to the intervention arm will be assigned to the Incredible Years parenting intervention immediately after enrollment. They will also receive enhanced mental health referrals and monthly follow-up phone calls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A caregiver is eligible to participate in the study if they meet the following entry requirements:
- 18 years of age or older at the start of the study
- Patient Health Questionnaire (PHQ) score of 3 or higher
- Have a child who is between 12 and 30 months at the time of screening
- Legal guardian of the child
Key exclusion criteria (6 listed)
- Caregiver scores negatively on the Patient Health Questionnaire (PHQ).
- Caregiver does not reside in Philadelphia County.
- Caregiver is under 18 years old.
- Caregiver has a child who is older or younger than 12 to 30 months.
- Caregiver is not the legal guardian of the child.
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 |
|---|---|---|
| The Incredible Years Parenting InterventionThe Incredible Years Parents, Babies, and Toddlers Program is a validated group parenting education program, which has been adapted for use with depressed caregivers by inclusion of psychoeducational depression materials. | Other | Intervention |
| Delayed InterventionCaregivers assigned to delayed intervention will be assigned to the Incredible Years parenting intervention 3-4 months after enrollment. | Other | Delayed Intervention |
Primary outcome
Feasibility of a Parent Coaching Intervention
Time frame: 3 months
Feasibility of the parent coaching intervention will be assessed by the proportion of participants who attended at least 10 sessions of Incredible Years over 3 months.
7 secondary outcomes
Change in Caregiver Depressive Symptoms
Time frame: 3 months
Acceptability of the Parent Coaching Intervention
Time frame: 3 months
Attendance at 6 or More Incredible Years (IY) Sessions
Time frame: 3 months
Feasibility of a Parent Coaching Intervention Incredible Years (IY) That Has Been Adapted for Depressed Caregivers.
Time frame: 3 months
Change in Parenting Stress
Time frame: 3 months
Change in Social Support
Time frame: 3 months
Change in Parenting Discipline
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28733799Boyd RC, Gerdes M, Rothman B, Dougherty SL, Localio R, Guevara JP. A Toddler Parenting Intervention in Primary Care for Caregivers With Depression Symptoms. J Prim Prev. 2017 Oct;38(5):465-480. doi: 10.1007/s10935-017-0481-8.
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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.
James Guevara, MD, MPH 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 study testing The Incredible Years Parenting Intervention and Delayed Intervention 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 7 inclusion and 6 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 11 Apr 2016. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2015). 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?
Feasibility of a Parent Coaching Intervention (time frame: 3 months). 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 NCT01464619, which also lists 1 linked publication.
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 11 Apr 2016; AzTrials last refreshed its copy on 1 Nov 2026.