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Substance AbusePhase 2NCT00319241

Relational Parenting Group for Opioid-addicted Mothers

A Phase 2 study testing Parenting Intervention in people with Substance Abuse and Child Abuse, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Substance Abuse, Child Abuse
What is being tested?
Parenting Intervention
How many people
120 participants
Where
1 siteUnited States
Study dates
Jan 1998to Nov 2003
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The APT Foundation

    New Haven, Connecticut, 06519

Other trials in United States

About this study

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

Read the detailed description

In this Stage II study, we will conduct a randomized clinical trial of the Relational Parenting Mothers' Group (RPMG), an intervention designed for opioid abusing mothers with children between the ages of 7 and 14 which was manualized and tested as part of a Stage I study (NIDA # P50-DA09241; September 1, 1994- August 31, 1997). This intervention was developed in recognition of the substantial psychosocial risks faced by substance abusing mothers and their offspring, and the notable lack of parenting interventions currently available for addicted mothers with children past the preschool years. Based on developmental psychopathology perspectives on resilience, this integrative treatment addresses multiple levels of adversity (individual, family, and community) faced by addicted mothers: risks that typically result in negative parenting behaviors and psychosocial distress among the mothers and concomitantly, psychiatric disturbance among their offspring. Designed as a supplement to standard drug counseling, RPMG is a structured and time-limited treatment, entailing 24 weekly group sessions of 1½ hours each.

Preliminary data collected in the Stage I pilot study have attested to the promise of RPMG in terms of diverse parenting behaviors and psychiatric outcomes among both mothers and their children. In the proposed study, we will conduct a randomized clinical trial in which mothers receiving RPMG as a supplement to Recovery Training (RT, a manualized group intervention representing standard drug counseling offered in methadone clinics) will be compared with those who receive RT alone. The RPMG clinical team will include one masters/doctoral level therapist and one assistant therapist and RT groups will be conducted by drug counselors; all therapists (RPMG \& RT) will be trained and supervised by our research team. One hundred sixty mothers will be randomized to one of the two treatment conditions. Multiple-method, multiple-informant assessments will be used to measure salient outcomes; these will include reports from mothers and their children, and from the mothers' clinicians and their children's teachers.

We will address the following specific aims in this study:

  1. We will evaluate the effectiveness of the Relational Parenting Mother's Group (RPMG) as a supplement to Recovery Training (RT) vs. Recovery Training alone in terms of a) mothers' parenting behaviors, b) their psychosocial adjustment, c) their children's psychosocial adjustment, and d) mothers' treatment compliance.
  2. We will evaluate the comparative durability of RPMG+RT vs. RT in terms of the outcomes in Aim #1, and in terms of delayed improvement in frequency of illicit drug use, HIV-risk behaviors, and other problems related to drug use.
  3. We will examine how specific maternal characteristics interact with treatment to affect outcomes. Guided by previous research, these characteristics will include mothers' intelligence, readiness for change, and sensation seeking.
Being tested
Parenting Intervention
Keywords
parenting intervention, substance abuse treatment, mother-child relations, parent-child relations, child abuse and neglect
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Parenting InterventionBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mother's risk for maltreating her child

  2. Mother's affective and instrumental parenting

  3. Mother's psychosocial adjustment

Secondary outcomes (2)
  1. Children's psychosocial adjustment

  2. Mother's substance abuse

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2006 (estimated)
  2. Study startJan 1998
  3. Primary completionOct 2003
  4. Study completionNov 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00319241
Sponsor's protocol ID
9401007365
Other IDs
R01DA011498
Status last verified
Jun 2008
First submitted
26 Apr 2006
Last updated
31 Mar 2020
Results posted
No

Publications

  • 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.

    PubMed 17241493

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Parenting Intervention in people with Substance Abuse and Child Abuse, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mother's risk for maltreating her child. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00319241, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.

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