A Pilot Intervention With Families of Children With Special Health Care Needs

Child Maltreatment Clinical Trial

Official title:

A Theory-Based Intervention to Prevent Child Neglect in High-Risk

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02742831
• Other study ID #: H-35105
• Secondary ID: 1K23HD078503-01A
• Status: Withdrawn
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot randomized controlled trial of a behavioral intervention focused on improving parenting skills and preventing child neglect in families of children with special health care needs. The intervention focuses on problem solving, distress tolerance, and emotional regulation skills.

Description:

This pilot randomized controlled trial will be conducted with 60 caregivers of children with special health care needs who have been reported to the child protection team at Boston Medical Center with concern for neglect that was ultimately not substantiated. Half of the subjects will be randomly assigned to receive the 6-session, one-on-one, in-person, behavioral intervention focused on problem solving, emotional regulation, and distress tolerance. The other half will be randomly assigned to the control group and will receive periodic check-ins and referrals to community resources as needed. Both groups will be followed for 12 months after randomization.

Children who have previously experienced neglect, or other forms of maltreatment, will not included in the study. Children will be defined as having special health care needs if they have a chronic physical, emotional, or behavioral condition.

With this pilot, the investigators aim to field-test study mechanics, including enrollment, randomization, and the collection of baseline and follow-up data; and obtain empiric estimates of study parameters to inform a subsequent fully-powered randomized controlled trial.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Primary caregiver of a child under age 7 with a special health care need, defined as a chronic physical, emotional, or behavioral health condition

• Child has been referred to the Child Protection Team for neglect that was ultimately not substantiated

• Fluent in English or Spanish

Exclusion Criteria:

• Prior history of substantiated child maltreatment

Related Conditions & MeSH terms

• Child Maltreatment
• Children With Special Health Care Needs (CSHCN)

Intervention

Behavioral:
• Intervention
The intervention group will receive a 6-session intervention. The overview of the 6 sessions is as follows: "Behavioral chain analysis" of episode where parent felt stressed with child and episode where things went well. Identification of sources of interpersonal support. Stress relief techniques. Identification of short and long-term goals. Development of a detailed crisis plan. Problem solving techniques. Emotional regulation. Exercises to identify moods and explore connections between feelings, thoughts, and behavior. Positive parenting, review of common and specific parenting challenges, child development, short and long-term effects of different discipline approaches. Reflection, repeat behavioral chain analysis. Update crisis plan.

Other:
• Control
The families in the control group will be contacted by a member of the study team 6 times in 12 weeks to approximate the frequency of contact that the intervention group receives. The study team member will check in with families on the telephone or in person and will help them connect with clinic and community resources as needed.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parental well-being and mental health - Quick Inventory of Depressive Symptomatology	The investigators will use validated measures to evaluate parental well-being. The measures include the Quick Inventory of Depressive Symptomatology. The investigators will analyze the measure as a continuous variable (overall score) and dichotomous variable (depression present or absent) and will obtain empirical estimates of the following study parameters to inform power calculations for a subsequent study: 1) within-group standard deviation of each continuous outcome measure; 2) proportion of control group subjects to experience each dichotomous outcome; and 3) correlation over time of the outcome measured at both baseline and follow-up. This will allow the investigators to power a later study, for both dichotomous and continuous outcomes.	Change in score from baseline to 12 months post randomization
Other	Parental well-being and mental health - the Social Adjustment Scale-Short Report	The investigators will use validated measures to evaluate parental well-being. The measures include the Social Adjustment Scale-Short Report. The investigators will analyze the measure as a continuous variable (overall score) and dichotomous variable (social adjustment present or absent) and will obtain empirical estimates of the following study parameters to inform power calculations for a subsequent study: 1) within-group standard deviation of each continuous outcome measure; 2) proportion of control group subjects to experience each dichotomous outcome; and 3) correlation over time of the outcome measured at both baseline and follow-up. This will allow the investigators to power a later study, for both dichotomous and continuous outcomes.	Change in score from baseline to 12 months post randomization
Other	Parental well-being and mental health - the Medical Outcomes Survey Social Support	The investigators will use validated measures to evaluate parental well-being. The measures include the Medical Outcomes Survey Social Support. The investigators will analyze the measure as a continuous variable (overall score) and dichotomous variable (social support present or absent) and will obtain empirical estimates of the following study parameters to inform power calculations for a subsequent study: 1) within-group standard deviation of each continuous outcome measure; 2) proportion of control group subjects to experience each dichotomous outcome; and 3) correlation over time of the outcome measured at both baseline and follow-up. This will allow the investigators to power a later study, for both dichotomous and continuous outcomes.	Change in score from baseline to 12 months post randomization
Other	Parental well-being and mental health - the Perceived Stress Scale	The investigators will use validated measures to evaluate parental well-being. The measures include the Perceived Stress Scale. The investigators will analyze the measure as a continuous variable (overall score) and dichotomous variable (stress present or absent) and will obtain empirical estimates of the following study parameters to inform power calculations for a subsequent study: 1) within-group standard deviation of each continuous outcome measure; 2) proportion of control group subjects to experience each dichotomous outcome; and 3) correlation over time of the outcome measured at both baseline and follow-up. This will allow the investigators to power a later study, for both dichotomous and continuous outcomes.	Change in score from baseline to 12 months post randomization
Other	Parental well-being and mental health - the Parenting Stress-Short Form	The investigators will use validated measures to evaluate parental well-being. The measures include the Parenting Stress-Short Form. The investigators will analyze the measure as a continuous variable (overall score) and dichotomous variable (parenting stress present or absent) and will obtain empirical estimates of the following study parameters to inform power calculations for a subsequent study: 1) within-group standard deviation of each continuous outcome measure; 2) proportion of control group subjects to experience each dichotomous outcome; and 3) correlation over time of the outcome measured at both baseline and follow-up. This will allow the investigators to power a later study, for both dichotomous and continuous outcomes.	Change in score from baseline to 12 months post randomization
Other	Parental well-being and mental health - the Parenting Scale	The investigators will use validated measures to evaluate parental well-being. The measures include the Parenting Scale. The investigators will analyze the measure as a continuous variable (overall score) and dichotomous variable (parenting style present or absent) and will obtain empirical estimates of the following study parameters to inform power calculations for a subsequent study: 1) within-group standard deviation of each continuous outcome measure; 2) proportion of control group subjects to experience each dichotomous outcome; and 3) correlation over time of the outcome measured at both baseline and follow-up. This will allow the investigators to power a later study, for both dichotomous and continuous outcomes.	Change in score from baseline to 12 months post randomization
Other	Parental well-being and mental health - the Parent Development Interview-Revised	The investigators will use validated measures to evaluate parental well-being. The measures include the Parent Development Interview-Revised. The investigators will analyze the measure as a continuous variable (overall score) and dichotomous variable (reflective functioning present or absent) and will obtain empirical estimates of the following study parameters to inform power calculations for a subsequent study: 1) within-group standard deviation of each continuous outcome measure; 2) proportion of control group subjects to experience each dichotomous outcome; and 3) correlation over time of the outcome measured at both baseline and follow-up. This will allow the investigators to power a later study, for both dichotomous and continuous outcomes.	Change in score from baseline to 12 months post randomization
Primary	Study Logistics - subject enrollment	As this is a pilot study, the primary objective is to field test study logistics, including subject enrollment. The investigators will review monthly counts of enrolled subjects from baseline to 12 months post-randomization, and will compare the number of subjects in each study arm to target enrollment goals. Because of emerging consensus that group-to-group comparisons in a pilot study are not only invalid but also misleading, estimating effect size is deliberately not our primary study objective.	Monthly change from baseline to 12 months post randomization
Primary	Study Logistics - fidelity of intervention delivery	For the intervention group, treatment fidelity will be assessed by audio taping a random 10% of sessions and scoring them with standardized instruments. The investigators will measure the proportion of sessions delivered with fidelity. Because of emerging consensus that group-to-group comparisons in a pilot study are not only invalid but also misleading, estimating effect size is deliberately not our primary study objective.	3 months post randomization
Secondary	Re-referral to child protection team or social services	The investigators will obtain empirical estimates of the proportion of control group subjects to be re-referred to child protection team or social services by 3 months post randomization. This will allow the investigators to power a later study for this dichotomous outcome.	3 months post randomization
Secondary	Re-referral to child protection team or social services	The investigators will obtain empirical estimates of the proportion of control group subjects to be re-referred to child protection team or social services by 6 months post randomization. This will allow the investigators to power a later study for this dichotomous outcome.	6 months post randomization
Secondary	Re-referral to child protection team or social services	The investigators will obtain empirical estimates of the proportion of control group subjects to be re-referred to child protection team or social services by 12 months post randomization. This will allow the investigators to power a later study for this dichotomous outcome.	12 months post randomization
Secondary	Adherence to recommended medical care	The investigators will conduct chart review to count the number of missed medical appointments, emergency department visits, and hospitalizations in the 90 days preceding the analysis. The investigators will specifically examine the proportion of control group subjects to experience each outcome and will use this data to power a later study.	3 months post randomization
Secondary	Adherence to recommended medical care	The investigators will conduct chart review to count the number of missed medical appointments, emergency department visits, and hospitalizations in the 90 days preceding the analysis. The investigators will specifically examine the proportion of control group subjects to experience each outcome and will use this data to power a later study.	6 months post randomization
Secondary	Adherence to recommended medical care	The investigators will conduct chart review to count the number of missed medical appointments, emergency department visits, and hospitalizations in the 90 days preceding the analysis. The investigators will specifically examine the proportion of control group subjects to experience each outcome and will use this data to power a later study.	12 months post randomization