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

NCT02742831 | Withdrawn

• 2 other identifiers: H-351051K23HD078503-01A1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Re-referral to child protection team or social services

  3 months post randomization

• Re-referral to child protection team or social services

  6 months post randomization

• Re-referral to child protection team or social services

  12 months post randomization

• Adherence to recommended medical care

  3 months post randomization

• Adherence to recommended medical care

  6 months post randomization

Other Outcomes (7)

• Parental well-being and mental health - Quick Inventory of Depressive Symptomatology

  Change in score from baseline to 12 months post randomization

• Parental well-being and mental health - the Social Adjustment Scale-Short Report

  Change in score from baseline to 12 months post randomization

• Parental well-being and mental health - the Medical Outcomes Survey Social Support

  Change in score from baseline to 12 months post randomization

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Intervention BEHAVIORAL

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.

Intervention

Control OTHER

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.

Control

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior history of substantiated child maltreatment

Sponsors & Collaborators

• Boston Medical Center: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Caroline J Kistin, MD, MSc

  Boston University School of Medicine/Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BMC Attending Physician

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: April 19, 2016
• Study Start: August 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 14, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)