Enhancing Parenting for Depressed Caregivers (EPDC)
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|ClinicalTrials.gov Identifier: NCT01464619|
Recruitment Status : Completed
First Posted : November 3, 2011
Results First Posted : March 6, 2015
Last Update Posted : April 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Depression||Other: The Incredible Years Parenting Intervention Other: Delayed Intervention||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Enhancing Parenting for Depressed Caregivers|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||November 2013|
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.
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.
- 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.
- Change in Caregiver Depressive Symptoms [ Time Frame: 3 months ]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.
- Acceptability of the Parent Coaching Intervention [ Time Frame: 3 months ]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)
- Attendance at 6 or More Incredible Years (IY) Sessions [ Time Frame: 3 months ]Feasibility of the parent coaching intervention will be assessed by the proportion of participants who attended at least 6 sessions of IY.
- Feasibility of a Parent Coaching Intervention Incredible Years (IY) That Has Been Adapted for Depressed Caregivers. [ Time Frame: 3 months ]Feasibility of the parent coaching intervention will be assessed by the proportion of participants who attended at least 1 session of IY.
- Change in Parenting Stress [ Time Frame: 3 months ]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.
- Change in Social Support [ Time Frame: 3 months ]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.
- Change in Parenting Discipline [ Time Frame: 3 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01464619
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||James Guevara, MD, MPH||Children's Hospital of Philadelphia|