Enhancing Parenting for Depressed Caregivers (EPDC)

This study has been completed.
Sponsor:
Collaborators:
American Academy of Pediatrics
HRSA/Maternal and Child Health Bureau
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01464619
First received: July 19, 2011
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Depression
Other: The Incredible Years Parenting Intervention
Other: Delayed Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Enhancing Parenting for Depressed Caregivers

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Feasibility of a parent coaching intervention Incredible Years that has been adapted for depressed caregivers. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Feasibility of the parent coaching intervention will be assessed by the proportion of participants who attended at least 10 sessions of Incredible Years.


Secondary Outcome Measures:
  • Change in caregiver depressive symptoms, parenting stress, parenting satisfaction, social support, response to child behaviors, and child development. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Caregivers will complete the following assessments at three study visits: Beck Depression Inventory II; Parenting Stress Index-Short Form; Parenting Scale; Multidimensional Scale of Perceived Social Support; Infant and Toddler Social and Emotional Assessment, and Bayley Scales of Infant and Toddler Development Screening Tool. Change scores will be compared to examine for differences in depressive symptoms, parenting stress, parenting satisfaction, social support, response to child behaviors, and child development.

  • Acceptability of the parent coaching intervention Incredible Years that has been adapted for depressed caregivers. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Acceptability of the parent coaching intervention will be assessed by completion of a satisfaction questionnaire at the conclusion of the parent sessions.

  • To identify facilitators and barriers to maternal depression screening among clinicians at seven primary care practices in Philadelphia. [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    Following completion of enrollment, providers who participated in depression screening at participating practices will be interviewed to identify barriers and facilitators to implementing depression screening in primary care practice. Twenty clinicians will be recruited to participate in a single interview lasting 30-60 minutes. Interviews will be audiotaped and transcribed. Clinicians will be queried as to their perceptions of parental depression, screening procedures, referral procedures, and barriers and facilitators to screening in primary care.

  • Feasibility of a parent coaching intervention Incredible Years that has been adapted for depressed caregivers. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Feasibility of the parent coaching intervention will be assessed by the proportion of participants who attended at least 6 sessions of Incredible Years.

  • Feasibility of a parent coaching intervention Incredible Years that has been adapted for depressed caregivers. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Feasibility of the parent coaching intervention will be assessed by the proportion of participants who attended at least 1 session of Incredible Years.


Enrollment: 61
Study Start Date: March 2010
Study Completion Date: November 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Delayed Intervention
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.
Other: Delayed Intervention
Caregivers assigned to delayed intervention will be assigned to the Incredible Years parenting intervention 3-4 months after enrollment.
Experimental: Intervention
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.
Other: The Incredible Years Parenting Intervention
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464619

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
American Academy of Pediatrics
HRSA/Maternal and Child Health Bureau
Investigators
Principal Investigator: James Guevara, MD, MPH Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01464619     History of Changes
Other Study ID Numbers: IRB 09-007271
Study First Received: July 19, 2011
Last Updated: February 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
Parenting
Early Child Development

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 27, 2014