NCT01586988

Brief Summary

The IMAGE intervention was developed to improve parenting and self-care skills in mothers infected with HIV. It is expected that an improvement in these areas will in turn improve the mother's physical and mental health as well as the child's mental health and behavioral adjustment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Feb 2011

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

February 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2011

Completed
10 months until next milestone

First Posted

Study publicly available on registry

April 27, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

Enrollment Period

2.1 years

First QC Date

July 1, 2011

Last Update Submit

November 23, 2016

Conditions

Keywords

HIVParentingself-caredisclosuremedication adherencemotherchildadolescent

Outcome Measures

Primary Outcomes (1)

  • Targeted Behaviors, Practices, and Skills and Maternal and Child Health

    Specific targets of the intervention, including parenting practices, parenting behaviors, and self care skills, will be evaluated. In addition, the mother's physical and mental health and the child's mental health and behavioral adjustment will be evaluated.

    3-months, 6-months, and 12-months

Secondary Outcomes (1)

  • Parenting Self-efficacy

    3-months, 6-months, and 12-months

Study Arms (2)

IMAGE Intervention

EXPERIMENTAL

mothers are provided the IMAGE Parenting and Self-Care intervention

Behavioral: IMAGE Intervention

Control

NO INTERVENTION

Standard care.

Interventions

Mothers in the intervention will receive four individual intervention sessions with a facilitator. The sessions will cover parenting and self care skills.

IMAGE Intervention

Eligibility Criteria

Age6 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • mother has confirmed diagnosis of HIV
  • well (HIV-) child, 6 to 14 years of age
  • mother is English or Spanish speaking
  • child is English speaking

You may not qualify if:

  • low cognitive/intellectual functioning (\<75) in mother or child
  • psychosis in mother or child

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA, Isap

Los Angeles, California, 90025-7539, United States

Location

Related Publications (1)

  • Murphy DA, Armistead L, Payne DL, Marelich WD, Herbeck DM. Pilot trial of a parenting and self-care intervention for HIV-positive mothers: the IMAGE program. AIDS Care. 2017 Jan;29(1):40-48. doi: 10.1080/09540121.2016.1204416. Epub 2016 Jul 4.

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2011

First Posted

April 27, 2012

Study Start

February 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

November 28, 2016

Record last verified: 2016-11

Locations