Skip to main content
OpenTrials
Completed

NCT Number: NCT04675099

Promoting Caregiver-child Attachment and Recovery Through Early Intervention (pCARE): A Pilot Randomized Control Trial

This purpose of this study is to use the existing infrastructure and therapeutic relationships developed by Early Intervention, a national system of child development programs, to make an evidence-based intervention for parents with substance use disorder, Mothering from the Inside Out, more readily accessible to postpartum women with substance use disorder. This study will assess the feasibility, acceptability, and preliminary outcomes of the intervention in a pilot randomized controlled trial. We will also identify key implementation domains that impact successful delivery. We hypothesize that the intervention will be feasible and acceptable to the study participants.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Parenting Substance Use Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Baystate Medical Center

Springfield, Massachusetts, 01109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English speaking
  • 18 years of age or older
  • Mother to an index child between birth and 2 years old at the time of estimated start of intervention delivery
  • Engaged in formal recovery supports (including but not limited to: Recovery Coaches, support groups specific to people in recovery, medication assisted treatment) at time of enrollment for a minimum 3 months
  • Willing to receive parenting supports for the index child through EI
  • Geographically based within the catchment area of participating EI programs

Exclusion criteria

  • Severe mental health problems (suicidal, homicidal, psychosis episodes within the past year)
  • Significant cognitive impairment (unable to give informed consent)
  • Has an index child that has complex medical problems that significantly impact the child's ability to interact with the parent (e.g. blindness, deafness, severe weakness, or paralysis)

Treatment and study plan

pCARE

Behavioral

"Mothering from the Inside Out" is an evidence-based intervention delivered in substance use treatment settings that helps mothers with substance use disorders foster parent-child attachment, cope with stressful parenting situations, and promote their child's healthy development. This 3 month counseling intervention both improves parent-child attachment and decreases rates of drug relapse among mothers. The proposed mechanism of action targeted by the intervention is a change in parental reflective functioning, defined as the capacity to recognize and make sense of mental states (especially emotional states) and understand how they influence behavior and relationships.

Other names: Mothering from the Inside Out

Standard Early Intervention services

Other

The state of Massachusetts provides voluntary early childhood development services to substance-exposed infants through a system of Early Intervention programs. These programs offer coordinated services to all infants and toddlers with disabilities and those at risk for developmental delays in homes and child centers beginning at birth.

Primary outcomes

  1. Recruitment and enrollment

    Time frame: Through study completion up to 3 months

    The number of mothers referred, approached, and enrolled in the study

  2. Number of Early Intervention services received

    Time frame: Through intervention period, an average of 6 months

    All Early Intervention services received by mothers and their child(ren)

  3. The duration of intervention sessions

    Time frame: Through intervention period, an average of 6 months

    Session duration in minutes

  4. The number of intervention sessions completed by mothers

    Time frame: Through intervention period, an average of 6 months

    The total number of sessions completed

  5. Mothers' perceived barriers and facilitators to intervention delivery

    Time frame: Through intervention period, an average of 6 months

    Qualitative perceptions of intervention logistics

  6. The number of supervision sessions completed by providers

    Time frame: Through intervention period for each mother participant, an average of 6 months

    The total number of sessions completed

  7. Early Intervention and additional services received by mothers after intervention period

    Time frame: Post-intervention up to 3 months

    Services received qualitatively listed by mothers

  8. Retention of study participants

    Time frame: Through study completion up to 3 months

    Time to loss of follow-up and perceived reason for discontinuation

  9. Qualitative perceptions of intervention sessions from mothers

    Time frame: Through intervention period, an average of 6 months

    Open-ended feedback of intervention sessions

  10. Qualitative perceptions of intervention sessions from Early Intervention providers

    Time frame: Through intervention period for each mother participant, an average of 6 months

    Open-ended feedback of intervention sessions

  11. Qualitative perceptions of intervention sessions from Early Intervention providers after intervention period

    Time frame: Post-intervention for each mother participant up to 3 months

    Open-ended feedback via a 30-minute interview

  12. Qualitative perceptions of intervention sessions from mothers after intervention period

    Time frame: 3 months after the completion of the intervention

    Open-ended feedback via a 30-minute interview

  13. Adherence of providers to the intervention according to a revised 9-point "Mothering from the Inside Out" Adherence Rating Scale

    Time frame: Through intervention period for each mother participant, an average of 6 months

    The revised Mothering from the Inside Out (MIO) Adherence Rating Scale is a 9-item measure rated on a 3-point scale for frequency of occurrence (never or seldom, sporadically, or consistent) and competence (poorly executed, adequately executed, or well-executed) of intervention delivery. The measure uses intervention session audio- or video- recordings and includes MIO specific fidelity and a measure of therapeutic alliance.

Secondary outcomes

  1. Changes in parental reflective functioning according to the Parent Development Interview (PDI)

    Time frame: 0, 3, and 6 months

    The Parent Development Interview (PDI) is a 14-item measure of parental reflective functioning in an interview format. Audio-recorded interviews are transcribed and coded on a 9-point Likert scale.

  2. Changes in parent-child interactions according to the Coding Interactive Behavior (CIB) manual

    Time frame: 0, 3, 6 months

    Conducting a Free Play Session (a 10 minute video-recorded and coded interaction, face-to-face interaction (infants) or play session) and analyzing using 5-point Likert scale and the Coding Interactive Behavior (CIB) manual, a global coding system with 43 items (22 parent, 16 infant, and 5 dyadic codes). There are six composite scales for: maternal sensitivity, maternal intrusiveness, child involvement, child negative emotionality, dyadic reciprocity and dyadic negative states; and two additional constructs for 12-36 month olds: maternal limit setting and child compliance.

Other outcomes

  1. Changes in psychiatric symptoms according to the Brief Symptom Index (BSI)

    Time frame: 0, 1, 2, 3, and 6 months

    The Brief Symptom Index (BSI) is a 53-item measure of psychiatric symptoms scored on a 5-point Likert scale (Cronbach's alpha = .97).

  2. Changes in depressive symptoms according to the Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 0, 1, 2, 3, and 6 months

    The Patient Health Questionnaire-9 (PHQ-9) is a widely used 9-item questionnaire rated on a 4-point scale with good psychometric properties including high internal consistency and construct validity.

  3. Changes in substance use behavior according to the Addiction and Child Welfare Questionnaire (ACWQ)

    Time frame: 0, 1, 2, 3, and 6 months

    The Addiction and Child Welfare Questionnaire (ACWQ) assesses past substance use and involvement with child welfare systems with yes or no questions as well as frequency on a 4- or 5- point scale.

  4. Changes in parenting stress according to the Parenting Stress Index (PSI)

    Time frame: 0, 1, 2, 3, and 6 months

    The Parenting Stress Index - Short Form (PSI) is a validated instrument assessing parenting stress (Cronbach's alpha = 0.93, test-retest coefficient = .96).

  5. Child development using the Batelle Developmental Inventory

    Time frame: At baseline

    Batelle Developmental Inventory contains data collected as part of Early Intervention assessments per the Early Intervention evaluation schedule. All assessments collected during the enrollment period.

Sponsors and collaborators

Lead sponsor

Baystate Medical Center

Other

Registry information

Acronym: pCARE

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Dec 19, 2020
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.