AzTrials
AzTrials

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.

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 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

Other trials in United States

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 groups in NCT01464619
Study groupRoleWhat they receive
Delayed InterventionExperimentalThose 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
InterventionExperimentalCaregivers 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  1. First posted3 Nov 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionJun 2012
  4. Study completionNov 2013

Resources

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)
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
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in