Skip to content

Enhancing Parenting for Depressed Caregivers

Enhancing Parenting for Depressed Caregivers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01464619
Acronym
EPDC
Enrollment
61
Registered
2011-11-03
Start date
2011-07-31
Completion date
2013-11-30
Last updated
2016-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Parenting, Early Child Development

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.

Interventions

OTHERThe 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.

Caregivers assigned to delayed intervention will be assigned to the Incredible Years parenting intervention 3-4 months after enrollment.

Sponsors

American Academy of Pediatrics
CollaboratorOTHER
HRSA/Maternal and Child Health Bureau
CollaboratorFED
Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of a Parent Coaching Intervention3 monthsFeasibility 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.

Secondary

MeasureTime frameDescription
Acceptability of the Parent Coaching Intervention3 monthsAcceptability 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) Sessions3 monthsFeasibility 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.3 monthsFeasibility of the parent coaching intervention will be assessed by the proportion of participants who attended at least 1 session of IY.
Change in Caregiver Depressive Symptoms3 monthsChange 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.
Change in Social Support3 monthsChange 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 Discipline3 monthsChange 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.
Change in Parenting Stress3 monthsChange 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. Delayed Intervention: Caregivers assigned to delayed intervention will be assigned to the Incredible Years parenting intervention 3-4 months after enrollment.
29
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. 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.
32
Total61

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up34

Baseline characteristics

CharacteristicDelayed InterventionInterventionTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
29 Participants32 Participants61 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
27 Participants26 Participants53 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
2 Participants6 Participants8 Participants
Sex: Female, Male
Female
29 Participants31 Participants60 Participants
Sex: Female, Male
Male
0 Participants1 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 320 / 29
serious
Total, serious adverse events
0 / 320 / 29

Outcome results

Primary

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.

Time frame: 3 months

Population: Original number who enrolled and were assigned to each group.

ArmMeasureValue (NUMBER)
InterventionFeasibility of a Parent Coaching Intervention6 participants
Delayed InterventionFeasibility of a Parent Coaching Intervention0 participants
Secondary

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)

Time frame: 3 months

Population: No satisfaction measures were collected from the control group, as they received the intervention in a delayed format after their study participation had ended.

ArmMeasureValue (MEAN)Dispersion
InterventionAcceptability of the Parent Coaching Intervention4.75 units on a scaleStandard Deviation 0.3
Secondary

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.

Time frame: 3 months

ArmMeasureValue (NUMBER)
InterventionAttendance at 6 or More Incredible Years (IY) Sessions31.3 percentage of subjects enrolled
Delayed InterventionAttendance at 6 or More Incredible Years (IY) Sessions13.8 percentage of subjects enrolled
Secondary

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.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Caregiver Depressive Symptoms-7.6 units on a scaleStandard Deviation 8.2
Delayed InterventionChange in Caregiver Depressive Symptoms-6.2 units on a scaleStandard Deviation 11
Secondary

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.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Parenting Discipline-0.3 units on a scaleStandard Deviation 0.5
Delayed InterventionChange in Parenting Discipline0 units on a scaleStandard Deviation 0.5
Secondary

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.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Parenting Stress-8.9 units on a scaleStandard Deviation 27.9
Delayed InterventionChange in Parenting Stress-6.1 units on a scaleStandard Deviation 16.3
Secondary

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.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
InterventionChange in Social Support0.4 units on a scaleStandard Deviation 1.2
Delayed InterventionChange in Social Support0.3 units on a scaleStandard Deviation 1.2
Secondary

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.

Time frame: 3 months

ArmMeasureValue (NUMBER)
InterventionFeasibility of a Parent Coaching Intervention Incredible Years (IY) That Has Been Adapted for Depressed Caregivers.19 participants
Delayed InterventionFeasibility of a Parent Coaching Intervention Incredible Years (IY) That Has Been Adapted for Depressed Caregivers.5 participants

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026