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Trial record 32 of 39 for:    "social services" | Not yet recruiting Studies

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

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified August 2016 by Caroline Kistin, Boston Medical Center
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Caroline Kistin, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT02742831
First received: April 5, 2016
Last updated: August 3, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention
Child Maltreatment Children With Special Health Care Needs (CSHCN) Behavioral: Intervention Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: A Theory-Based Intervention to Prevent Child Neglect in High-Risk Families

Further study details as provided by Caroline Kistin, Boston Medical Center:

Primary Outcome Measures:
  • Study Logistics - subject enrollment [ Time Frame: Monthly change from baseline to 12 months post randomization ]
    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.

  • Study Logistics - fidelity of intervention delivery [ Time Frame: 3 months post randomization ]
    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.


Secondary Outcome Measures:
  • Re-referral to child protection team or social services [ Time Frame: 3 months post randomization ]
    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.

  • Re-referral to child protection team or social services [ Time Frame: 6 months post randomization ]
    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.

  • Re-referral to child protection team or social services [ Time Frame: 12 months post randomization ]
    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.

  • Adherence to recommended medical care [ Time Frame: 3 months post randomization ]
    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.

  • Adherence to recommended medical care [ Time Frame: 6 months post randomization ]
    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.

  • Adherence to recommended medical care [ Time Frame: 12 months post randomization ]
    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.


Other Outcome Measures:
  • Parental well-being and mental health - Quick Inventory of Depressive Symptomatology [ Time Frame: Change in score from baseline to 12 months post randomization ]
    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.

  • Parental well-being and mental health - the Social Adjustment Scale-Short Report [ Time Frame: Change in score from baseline to 12 months post randomization ]
    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.

  • Parental well-being and mental health - the Medical Outcomes Survey Social Support [ Time Frame: Change in score from baseline to 12 months post randomization ]
    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.

  • Parental well-being and mental health - the Perceived Stress Scale [ Time Frame: Change in score from baseline to 12 months post randomization ]
    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.

  • Parental well-being and mental health - the Parenting Stress-Short Form [ Time Frame: Change in score from baseline to 12 months post randomization ]
    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.

  • Parental well-being and mental health - the Parenting Scale [ Time Frame: Change in score from baseline to 12 months post randomization ]
    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.

  • Parental well-being and mental health - the Parent Development Interview-Revised [ Time Frame: Change in score from baseline to 12 months post randomization ]
    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.


Estimated Enrollment: 60
Study Start Date: September 2016
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention

The intervention group will receive a one-on-one in-person intervention of 6 sessions, each lasting approximately 60 minutes. The intervention is intended to be delivered over a period of 12 weeks, with sessions occurring every 1-2 weeks. The overview of the 6 sessions is as follows:

  1. Behavioral chain analysis of episodes where parent felt stressed and episode where things went well. Identification of sources of interpersonal support.
  2. Stress relief. Development of a detailed crisis plan.
  3. Problem solving techniques.
  4. Emotional regulation exercises.
  5. Positive parenting, review of parenting challenges.
  6. Reflection, repeat behavioral chain analysis. Update crisis plan.
Behavioral: Intervention

The intervention group will receive a 6-session intervention. The overview of the 6 sessions is as follows:

  1. "Behavioral chain analysis" of episode where parent felt stressed with child and episode where things went well. Identification of sources of interpersonal support.
  2. Stress relief techniques. Identification of short and long-term goals. Development of a detailed crisis plan.
  3. Problem solving techniques.
  4. Emotional regulation. Exercises to identify moods and explore connections between feelings, thoughts, and behavior.
  5. Positive parenting, review of common and specific parenting challenges, child development, short and long-term effects of different discipline approaches.
  6. Reflection, repeat behavioral chain analysis. Update crisis plan.
Active Comparator: 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.
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02742831

Contacts
Contact: Caroline J Kistin, MD, MSc 617-620-2156 caroline.kistin@bmc.org

Locations
United States, Massachusetts
Boston Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02118
Contact: Caroline J Kistin, MD, MSc    617-414-3642      
Principal Investigator: Caroline J Kistin, MD, MSc         
Principal Investigator: Michael Silverstein, MD, MPH         
Sponsors and Collaborators
Boston Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Caroline J Kistin, MD, MSc Boston University School of Medicine/Boston Medical Center
  More Information

Responsible Party: Caroline Kistin, BMC Attending Physician, Boston Medical Center
ClinicalTrials.gov Identifier: NCT02742831     History of Changes
Other Study ID Numbers: K23HD078503 ( U.S. NIH Grant/Contract )
1K23HD078503-01A1 ( U.S. NIH Grant/Contract )
Study First Received: April 5, 2016
Last Updated: August 3, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

ClinicalTrials.gov processed this record on July 21, 2017