MIO-CPP for Parental Substance Use Disorders Impact on Children

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Non-English speaking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the well-being of children and families affected by parental substance use disorders by testing a combination of therapies. It explores two treatments: MIO-CPP, which strengthens the mother-child bond, and a version that includes support from Certified Recovery Specialists (CRS) to assist mothers in transitioning back into their communities. Mothers receiving treatment for substance use disorder who have children under six or are at least six months pregnant may be eligible. The trial will evaluate the effectiveness of these treatments in improving outcomes for both parent and child. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could significantly enhance family well-being.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that participants generally handle the MIO-CPP treatment well. Studies on similar combined treatments have shown promise in improving outcomes for both mothers and children dealing with substance use issues. Mothers in these programs often report better parenting skills, and children usually show improved social and emotional development.

Early results for the MIO-CPP-CRS approach, which includes help from Certified Recovery Specialists, are also positive. Mothers who participated in Child-Parent Psychotherapy (CPP) successfully reunited with their families. Adding recovery specialists aims to help parents transition smoothly out of treatment, potentially supporting a safe and stable home environment.

These therapies focus on improving family relationships and child well-being, and evidence so far suggests they are safe to participate in. No significant reports of negative effects related to these therapies have emerged. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MIO-CPP and MIO-CPP-CRS treatments because they offer a novel, integrated approach for addressing parental substance use disorders and their impact on children. Unlike standard treatments, which often focus solely on the parent or child separately, MIO-CPP combines Mothering from the Inside Out (MIO) with Child-Parent Psychotherapy (CPP) to enhance both the parent's reflective functioning and the parent-child relationship. The MIO-CPP-CRS variant adds an extra layer of support with Certified Recovery Specialists (CRS), who help families transition smoothly back into their communities. This holistic approach aims to provide comprehensive support, potentially leading to more stable, long-term recovery outcomes for families.

What evidence suggests that this trial's treatments could be effective for improving child and family well-being in families affected by parental substance use disorders?

Research has shown that the MIO-CPP model, one of the treatment arms in this trial, can enhance the relationship between parents and children affected by substance use problems. This approach helps parents understand and respond to their child's needs, strengthening their bond and improving emotional and behavioral outcomes for children.

Another treatment arm, the MIO-CPP-CRS model, includes Certified Recovery Specialists (CRS) to provide additional support as parents reintegrate into their communities. The MIO component, which focuses on mothers in substance use treatment, has improved parenting and reduced depression symptoms. By combining these therapies, the model aims to create a more supportive environment for both parents and children as they work towards recovery. ^{1 2 3 6 7}

Who Is on the Research Team?

Meredith Matone, DrPH, MHS

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for mothers in Philadelphia and Bucks Counties who are receiving treatment for Substance Use Disorder at specified clinics, are at least six months pregnant or have a child under five years old. The children must live with the mother or be on track to reunify if currently in foster care. Mothers must speak English without needing an interpreter.

Inclusion Criteria

I have access to my child, either living with me or planned reunification.

I am at least six months pregnant or have a child under 5 years old.

Women actively receiving treatment for Substance Use Disorder at one of three participating clinics in Philadelphia and Bucks Counties: Libertae Inc.; The Caring Together Program; Interim House West; the Neonatal Follow-up Program at CHOP; Penn Family Care; the Temple Opioid Program; the Maternal, Child, and Family Health Doula Support Program; and the Einstein Hospital Perinatal Substance Use Team

Exclusion Criteria

I can receive services in English without needing an interpreter.

I have been in the treatment facility for at least 14 days but not close to discharge within 45 days.

I have completed at least 2 weeks of visits at Caring Together clinic.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MIO-CPP Intervention

Participants receive 12 weeks of MIO with CPP assessment and engagement phase embedded, followed by the dyadic mother-child phase of CPP.

12 weeks

Weekly sessions

CRS Support

Participants in Phase 2 receive support from Certified Recovery Specialists (CRS) to assist with transition out of SUD treatment and back into their home communities.

9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with data collection at multiple time points.

9 months

Data collection at baseline, 3, 6, and 9 months

What Are the Treatments Tested in This Trial?

Interventions

• CPP-only
• MIO-CPP

Trial Overview The study tests Mothering from the Inside Out (MIO) combined with Child Parent Psychotherapy (CPP), aiming to improve parent-child relationships and reduce child welfare system involvement. Phase 1 participants receive MIO-CPP only, while Phase 2 also includes support from Certified Recovery Specialists (CRS).

How Is the Trial Designed?

Group I: MIO-CPP-CRS Experimental Treatment 1 Intervention

In Phase 2, participants will receive MIO-CPP therapy, as well as support from a CRS. The MIO-CPP model will begin with 6 sessions of MIO for each study participant, with the CPP assessment and engagement phase embedded during this time. This phase will be followed by the dyadic mother-child phase, the core intervention stage of CPP. If a parent needs additional stabilization, more individual time can be added. During the core phase of dyadic CPP the Child Parent Specialists will continue to build and strengthen parents' reflective functioning by embedding aspects from MIO. Participant dyads will be assigned a Certified Recovery Specialists (CRSs) who will provide services to support them as they transition out of SUD treatment and back into their home communities.

Group II: MIO-CPP Active Control 1 Intervention

The 9 month MIO-CPP model will begin with the standard 12 weeks of MIO for each mother, with the CPP assessment and engagement phase embedded during this time. This phase will be followed by the dyadic mother-child phase, the core intervention stage of CPP. If a parent needs additional stabilization, more individual time can be added. During the core phase of dyadic CPP the Child Parent Specialists will continue to build and strengthen parents' reflective functioning by embedding aspects from MIO. The 9 month MIO-CPP model will begin with the standard 12 weeks of MIO for each mother, with the CPP assessment and engagement phase embedded during this time. This phase will be followed by the dyadic mother-child phase, the core intervention stage of CPP. If a parent needs additional stabilization, more individual time can be added.

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Health Federation of Philadelphia

Collaborator

Trials

2

Recruited

1,200+

Libertae, Inc.

Collaborator

Trials

1

Recruited

320+

Health Federation of Philadelphia

Collaborator

Trials

1

Recruited

320+

Gaudenzia Hutchinson Place

Collaborator

Trials

1

Recruited

320+

Gaudenzia Winner Program

Collaborator

Trials

1

Recruited

320+

Interim House West

Collaborator

Trials

1

Recruited

320+

The Caring Together Program

Collaborator

Trials

1

Recruited

320+

The Neonatal Follow-up Program at Children's Hospital of Philadelphia

Collaborator

Trials

1

Recruited

320+

Penn Family Care

Collaborator

Trials

1

Recruited

320+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04294134

MIO-CPP to Improve the Well-being, Permanency, and ... MIO-CPP promotes the development of parental reflective functioning and strengthen parent/child attachment. The project will also examine the role of Certified ...

2. withpower.com withpower.com/trial/phase-substance-related-disorders-2020-1a7ad

MIO-CPP for Parental Substance Use Disorders Impact on ... MIO-CPP promotes the development of parental reflective functioning and strengthen parent/child attachment. The project will also examine the role of Certified ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3725219/

The Impact of Substance Use Disorders on Families and ... SUDs negatively affect emotional and behavioral patterns from the inception of the family, resulting in poor outcomes for the children and adults with SUDs.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8685508/

Parent‐infant psychotherapy for improving ... - PubMed Central Parent‐infant psychotherapy (PIP) is a dyadic intervention that works with parent and infant together, with the aim of improving the parent‐infant relationship.

5. childparentpsychotherapy.com childparentpsychotherapy.com/wp-content/uploads/2024/05/Hazen-et-al-2021-ordering-cpp.pdf

Parent Psychotherapy on Child Dependency Court Outcomes Improving the outcomes of children affected by parental substance abuse: a review of randomized controlled trials. Substance Abuse and. Rehabilitation, 6, 15–24 ...

6. tandfonline.com tandfonline.com/doi/full/10.1080/15295192.2024.2422872?af=R

Development of a Clinical Decision-Making Framework to ... A clinical decision-making framework designed to help standardize clinicians' discussions around whether substance use could be affecting a parent's ability to ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/imhj.70029

Effects of integrated programs for substance‐involved ... Integrated interventions that jointly address maternal substance use and child development have shown promise for enhancing child outcomes. No ...