Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Changes in psychiatric symptoms according to the Brief Symptom Index (BSI) |
The Brief Symptom Index (BSI) is a 53-item measure of psychiatric symptoms scored on a 5-point Likert scale (Cronbach's alpha = .97). |
0, 1, 2, 3, and 6 months |
|
Other |
Changes in depressive symptoms according to the Patient Health Questionnaire-9 (PHQ-9) |
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. |
0, 1, 2, 3, and 6 months |
|
Other |
Changes in substance use behavior according to the Addiction and Child Welfare Questionnaire (ACWQ) |
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. |
0, 1, 2, 3, and 6 months |
|
Other |
Changes in parenting stress according to the Parenting Stress Index (PSI) |
The Parenting Stress Index - Short Form (PSI) is a validated instrument assessing parenting stress (Cronbach's alpha = 0.93, test-retest coefficient = .96). |
0, 1, 2, 3, and 6 months |
|
Other |
Child development using the Batelle Developmental Inventory |
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. |
At baseline |
|
Primary |
Recruitment and enrollment |
The number of mothers referred, approached, and enrolled in the study |
Through study completion up to 3 months |
|
Primary |
Number of Early Intervention services received |
All Early Intervention services received by mothers and their child(ren) |
Through intervention period, an average of 6 months |
|
Primary |
The duration of intervention sessions |
Session duration in minutes |
Through intervention period, an average of 6 months |
|
Primary |
The number of intervention sessions completed by mothers |
The total number of sessions completed |
Through intervention period, an average of 6 months |
|
Primary |
Mothers' perceived barriers and facilitators to intervention delivery |
Qualitative perceptions of intervention logistics |
Through intervention period, an average of 6 months |
|
Primary |
The number of supervision sessions completed by providers |
The total number of sessions completed |
Through intervention period for each mother participant, an average of 6 months |
|
Primary |
Early Intervention and additional services received by mothers after intervention period |
Services received qualitatively listed by mothers |
Post-intervention up to 3 months |
|
Primary |
Retention of study participants |
Time to loss of follow-up and perceived reason for discontinuation |
Through study completion up to 3 months |
|
Primary |
Qualitative perceptions of intervention sessions from mothers |
Open-ended feedback of intervention sessions |
Through intervention period, an average of 6 months |
|
Primary |
Qualitative perceptions of intervention sessions from Early Intervention providers |
Open-ended feedback of intervention sessions |
Through intervention period for each mother participant, an average of 6 months |
|
Primary |
Qualitative perceptions of intervention sessions from Early Intervention providers after intervention period |
Open-ended feedback via a 30-minute interview |
Post-intervention for each mother participant up to 3 months |
|
Primary |
Qualitative perceptions of intervention sessions from mothers after intervention period |
Open-ended feedback via a 30-minute interview |
3 months after the completion of the intervention |
|
Primary |
Adherence of providers to the intervention according to a revised 9-point "Mothering from the Inside Out" Adherence Rating Scale |
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. |
Through intervention period for each mother participant, an average of 6 months |
|
Secondary |
Changes in parental reflective functioning according to the Parent Development Interview (PDI) |
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. |
0, 3, and 6 months |
|
Secondary |
Changes in parent-child interactions according to the Coding Interactive Behavior (CIB) manual |
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. |
0, 3, 6 months |
|