NCT01464619

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Jul 2011

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 3, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 6, 2015

Completed
Last Updated

April 11, 2016

Status Verified

March 1, 2016

Enrollment Period

11 months

First QC Date

July 19, 2011

Results QC Date

February 3, 2015

Last Update Submit

March 11, 2016

Conditions

Depression

Keywords

ParentingEarly Child Development

Outcome Measures

Primary Outcomes (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.

    3 months

Secondary Outcomes (7)

  • Change in Caregiver Depressive Symptoms

    3 months

  • Acceptability of the Parent Coaching Intervention

    3 months

  • Attendance at 6 or More Incredible Years (IY) Sessions

    3 months

  • Feasibility of a Parent Coaching Intervention Incredible Years (IY) That Has Been Adapted for Depressed Caregivers.

    3 months

  • Change in Parenting Stress

    3 months

  • +2 more secondary outcomes

Study Arms (2)

Delayed Intervention

EXPERIMENTAL

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

Intervention

EXPERIMENTAL

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

Interventions

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.

Intervention
Delayed InterventionOTHER

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

Delayed Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A caregiver is eligible to participate in the study if they meet the following entry requirements:
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 28733799DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Limitations and Caveats

Outcomes are assessed by maternal report measures only. Incentives were given for completing the adapted IY group. There was poor attendance at IY sessions. The study was conducted in only one geographic area .

Results Point of Contact

Title
James Guevara, MD, MPH
Organization
The Children's Hospital of Philadelphia
guevara@email.chop.edu
215-590-1130

Study Officials

  • James Guevara, MD, MPH

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2011

First Posted

November 3, 2011

Study Start

July 1, 2011

Primary Completion

June 1, 2012

Study Completion

November 1, 2013

Last Updated

April 11, 2016

Results First Posted

March 6, 2015

Record last verified: 2016-03

Locations

US(1)