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NCT00319436 · ClinicalTrials.gov registry record · NA

Stage I Randomized Trial of Mentalization-Based Therapy for Substance Using Mothers of Infants and Toddlers

A NA study of Maternal Substance Use and Child Abuse and Neglect, sponsored by Yale University.

Completed
Registry status
NA
Development phase
47
Enrollment target
1
Study location

NCT00319436: Completed NA study of Maternal Substance Use and Child Abuse and Neglect, sponsored by Yale University.

NCT00319436 is a NA study of Maternal Substance Use and Child Abuse and Neglect that has completed, run by Yale University. The registered enrollment target is 47 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00319436, a NA study of Maternal Substance Use and Child Abuse and Neglect, has completed, sponsored by Yale University.

COMPLETED
Registry status
NA
Development phase
47 participants
Enrollment target
1
Study location

Study Summary

The primary goal of this Stage I therapy development study will be to manualize and test the preliminary efficacy of a parenting intervention for drug dependent mothers that aims to foster their ability to recognize children's emotional needs at different ages and their capacity to be emotionally available to their children.

Primary Outcome

The Parent Development Interview (PDI) was used to measure maternal capacity to mentalize about her own and her child's behavior. The PDI is a 1 hour semi-structured interview designed to elicit the mother's narrative about commonly occurring, emotionally-challenging aspects of parenting. A rating of 1 indicates a absence of recognition of mental states. A rating of 3 indicates a limited capacity to acknowledge mental states. A rating of 5 indicates the presence of a rudimentary capacity for ref

Interventions

  • BEHAVIORAL Mentalizing Therapy for Substance Using Mothers
  • BEHAVIORAL Standard Parent Education for Substance Using Mothers

Study Locations (1)

Connecticut

  • The APT Foundation - New Haven

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2004-08
Est. Completion 2009-03
Phase NA
Yale University

1,492 total trials

What the finished NCT00319436 record still lists

NCT00319436 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 2 conditions, with Maternal Substance Use appearing as the primary indexed condition, and to 2 interventions - of which Mentalizing Therapy for Substance Using Mothers is the first listed.

NCT00319436 reports a single indexed study location in Connecticut.

Frequently Asked Questions

What is clinical trial NCT00319436 about?

NCT00319436 is a clinical study titled "Stage I Randomized Trial of Mentalization-Based Therapy for Substance Using Mothers of Infants and Toddlers". The primary goal of this Stage I therapy development study will be to manualize and test the preliminary efficacy of a parenting intervention for drug dependent mothers that aims to foster their ability to recognize children's emotional needs at different ages and their capacity to be emotionally av...

What is the current status of trial NCT00319436?

This trial is currently completed. It is a NA study. The enrollment target is 47 participants. The study started on 2004-08. Estimated completion is 2009-03.

What conditions does trial NCT00319436 study?

This clinical trial studies the following conditions: Maternal Substance Use, Child Abuse and Neglect.

What interventions are being tested in trial NCT00319436?

The interventions under investigation include: Mentalizing Therapy for Substance Using Mothers (BEHAVIORAL), Standard Parent Education for Substance Using Mothers (BEHAVIORAL).

Who is sponsoring clinical trial NCT00319436?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00319436 being conducted?

This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT00319436's enrollment target sits among peer trials

47 1400th of 2000 higher than 599 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00319436, the US trial registry maintained by the National Library of Medicine. NCT00319436 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.