Clinical trial NCT01464619: Enhancing Parenting for Depressed Caregivers
Official title: Enhancing Parenting for Depressed Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Parenting
Early Child Development
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: American Academy of Pediatrics
name: HRSA/Maternal and Child Health Bureau
First posted: 2011-11-03
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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.

Primary outcomes:
measure: Feasibility of a Parent Coaching Intervention
timeFrame: 3 months
Secondary outcomes:
measure: Change in Caregiver Depressive Symptoms
timeFrame: 3 months
measure: Acceptability of the Parent Coaching Intervention
timeFrame: 3 months
measure: Attendance at 6 or More Incredible Years (IY) Sessions
timeFrame: 3 months
measure: Feasibility of a Parent Coaching Intervention Incredible Years (IY) That Has Been Adapted for Depressed Caregivers.
timeFrame: 3 months
measure: Change in Parenting Stress
timeFrame: 3 months
measure: Change in Social Support
timeFrame: 3 months
measure: Change in Parenting Discipline
timeFrame: 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: James Guevara, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.