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Improving Self-Regulation Among Adopted Children

NCT04061031 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-12-16

No results posted yet for this study

Summary

The proposed study will examine two different intervention programs and whether they improve self-regulation of adopted children. The study is a small randomized controlled trial to test the feasibility of conducting a larger, R01-funded clinical trial. Outcomes will primarily be focused on feasibility concerns, such as recruitment and retention of a sufficient number of participants and implementation of treatment protocols with fidelity, as well as determining initial effect size estimates that might inform later power analyses and examining the functioning of developmental assessment measures when administered in the context of a clinical trial.

Conditions

  • Self-regulation

Interventions

BEHAVIORAL

Parent-Child Interaction Therapy (PCIT)

A trained clinician teaches the caregiver to deliver a number of behavior modification techniques for use with the child and coaches the caregiver in the delivery of those techniques.

BEHAVIORAL

Child-Centered Therapy with Parent Education

A trained clinician delivers non-directive, child-centered treatment techniques with the child while providing education to the parent based on current recommendations from the Department of Health and Human Services' Child Welfare Information Gateway.

Sponsors & Collaborators

  • Milton S. Hershey Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-14
Primary Completion
2022-10-01
Completion
2022-10-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04061031 on ClinicalTrials.gov