N/A
N=47
Stage I Randomized Trial of Mentalization-Based Therapy for Substance Using Mothers of Infants and Toddlers
Maternal Substance Use · Child Abuse and Neglect
Bottom Line
View on ClinicalTrials.gov: NCT00319436 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Maternal Capacity for Reflective Functioning (Assessed With the Parent Development Interview) — 3.59; 3.08; 3.54; 3.47 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mentalizing Therapy for Substance Using Mothers (Behavioral); Standard Parent Education for Substance Using Mothers (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Yale University
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maternal Capacity for Reflective Functioning (Assessed With the Parent Development Interview) |
3.59; 3.08; 3.54; 3.47; 3.47; 3.09 | — |
| PRIMARY Quality of Maternal Representations of the Child (Assessed With the Working Model of the Child Interview) |
2.86; 2.78; 2.86; 2.71 | — |
| SECONDARY Maternal Caregiving Behavior (Assessed With the NCAST Teaching Scales) |
37.79; 35.75; 14.60; 13.01; 37.06; 34.61 | — |
| SECONDARY Child Behavior (Assessed With the NCAST Teaching Scales) |
19.74; 18.78; 9.47; 9.16; 20.16; 18.66 | — |
| SECONDARY Maternal Depression (Measured With the Beck Depression Inventory) |
13.57; 16.01; 14.37; 12.14 | — |
| SECONDARY Maternal Psychiatric Distress (Assessed With the Brief Symptom Inventory) |
58.86; 60.24; 58.41; 58.29 | — |
| SECONDARY Maternal Substance Abuse (Assessed With Urine Toxicology Screens) |
20; 22; 7; 6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- English-speaking adult women
- history of primary alcohol, cocaine, cannabis, club drug, or heroin abuse or dependence
- caring for a child between 1 and 36 months of age
Exclusion criteria
- acute suicidality/ homicidality
- severe psychiatric or substance-related symptoms requiring in-patient hospitalization or ambulatory detoxification
Data sourced from ClinicalTrials.gov (NCT00319436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.