NCT00319241

Brief Summary

This study is a randomized trial of interventions to improve parent-child relationships of drug-dependent mothers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 1998

Longer than P75 for phase_2

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

January 1, 1998

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
Last Updated

March 31, 2020

Status Verified

June 1, 2008

Enrollment Period

5.8 years

First QC Date

April 26, 2006

Last Update Submit

March 27, 2020

Conditions

Substance AbuseChild Abuse

Keywords

parenting interventionsubstance abuse treatmentmother-child relationsparent-child relationschild abuse and neglect

Outcome Measures

Primary Outcomes (3)

  • Mother's risk for maltreating her child

  • Mother's affective and instrumental parenting

  • Mother's psychosocial adjustment

Secondary Outcomes (2)

  • Children's psychosocial adjustment

  • Mother's substance abuse

Interventions

Parenting InterventionBEHAVIORAL

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female adult humans
  • enrollment in methadone treatment for opioid addiction
  • caring for a child between the ages of 7 and 14 years

You may not qualify if:

  • suicidality/homicidality requiring more intensive level of care
  • serious cognitive impairment (AIDS-related dementia or schizophrenia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The APT Foundation

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

  • Luthar SS, Suchman NE, Altomare M. Relational Psychotherapy Mothers' Group: a randomized clinical trial for substance abusing mothers. Dev Psychopathol. 2007 Winter;19(1):243-61. doi: 10.1017/S0954579407070137.

    PMID: 17241493RESULT

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Suniya Luthar, Ph.D.

    Teachers College, Columbia University

    PRINCIPAL INVESTIGATOR

  • Nancy Suchman, Ph.D.

    Yale University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 26, 2006

First Posted

April 27, 2006

Study Start

January 1, 1998

Primary Completion

October 1, 2003

Study Completion

November 1, 2003

Last Updated

March 31, 2020

Record last verified: 2008-06

Locations

US(1)