Parent Encouragement And Coaching of Happiness in Youth

NCT06725160 | Recruiting

• 2 other identifiers: STUDY24040170R01MH135881
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this mechanistic clinical trial is to examine whether parent-coaching aimed at increasing child positive affect will increase child neural response to reward. The main questions it aims to answer are: Aim 1. Characterize child neural reward response and its relation to maternal socialization of positive emotions at baseline in healthy young children. Aim 2. Evaluate how coaching-related changes in maternal socialization of positive emotion expression contribute to increases in child neural reward response over time. Aim 3. Examine how maternal socialization of positive emotion expression contributes to increases in child neural reward response in the moment. Participating mother-child dyads will be randomized to either 3 sessions of parent coaching of child positive affect or 3 sessions of a general parenting support intervention and neural response to reward and affective behavior will be examined pre and post intervention.

Conditions

Depression; Parent-Child Relations

Keywords

depression; reward; neural; behavior; parent; early childhood

Outcome Measures

Primary Outcomes (1)

• Reward Positivity (RewP)

  The Reward Positivity (RewP) ERP component of the EEG signal is the mean amplitude (μV; microvolt) on gain-loss trials during receipt of reward related feedback in a computerized reward task with higher RewP amplitudes indicating greater reward response (i.e., more favorable outcome).

  From baseline week 1 to final assessment week 5 (week 10 maximum)

Secondary Outcomes (3)

• Parent Responses to Child Positive affect Scale (PRCPS)

  From baseline week 1 to final assessment week 5 (week 10 maximum)

• Behavioral Coding of Parental Encouragement of Child Positive Emotion

  From baseline week 1 to final assessment week 5 (week 10 maximum)

• Late Positive Potential (LPP)

  From baseline week 1 to final assessment week 5 (week 10 maximum)

Study Arms (2)

Parent Coaching

EXPERIMENTAL

Parents will receive 3 sessions based on PCIT-ED aimed at increasing child positive affect.

Behavioral: Parent Coaching

Active Control

ACTIVE COMPARATOR

Parents will receive 3 sessions based on traditional PCIT providing more general parenting supporting, including basic psychoeducation and parenting skills.

Behavioral: Active Control

Interventions

Parent Coaching BEHAVIORAL

Three sessions of parent coaching of child positive affect will be administered based on modules from PCIT-ED.

Also known as: PCIT-ED

Parent Coaching

Active Control BEHAVIORAL

General parent support and psychoeducation based on components of standard PCIT.

Active Control

Eligibility Criteria

• Age: 4 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Birth mother (biologically female, any gender)
• Providing regular care for participating child (i.e., at least 50% of time)
• Elevated, clinically significant levels of depression (16 or higher on CES-D)
• Aged 18+

You may not qualify if:

• Lifetime history of a bipolar disorder
• Lifetime history of a psychotic disorder
• Aged 4-6 years
• T-score greater than 63 on the internalizing or externalizing composites of the CBCL
• Lifetime history of a psychiatric illness
• Lifetime history of neurodevelopmental disorder
• Lifetime history of neurological disorder

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Depression; Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms

Study Officials

• Judith M Morgan, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Lauren M. Bylsma, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Research Coordinator

CONTACT

412-509-8787; PEACHY@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: October 28, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: We will begin to upload data to the NIH NDA beginning in July 2025 per NIMH requirements, which would then be made publicly available by November 2025. Data in the NDA will be made available indefinitely as long as the NDA exists as a resource.
• Access Criteria: Informed consent documents, protocol information, and statistical analysis plan information will all be uploaded to clinicaltrials.gov. Access to participant level data will be managed by the NIH National Data Archive where all the individual participant data and supporting information will be uploaded. Additional data regarding statistical analyses and corresponding code will be provided as supplemental material to publications that use this data. Since this is a mechanistic clinical trial and not an RCT, a CSR is not applicable.

Locations

US (1)