Prevention of Anhedonia in Children

Sponsor
Vanderbilt University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05988138
Collaborator
Nationwide Children's Hospital (Other)
60
2
21

Study Details

Study Description

Brief Summary

This trial will test the effects of a positive emotion-focused preventive intervention on reward responsiveness in children of mothers with histories of depression and anhedonia.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Family Promoting Positive Emotions
  • Behavioral: Psychoeducation
N/A

Detailed Description

This study will test the effects of a dyadic preventive intervention, Family Promoting Positive Emotion (F-PPE), for 8- to 12-year-old children of mothers with a history of major depressive disorder (MDD) with anhedonia. The study will first test F-PPE effects on child reward responsiveness (R61), and pending evidence of target engagement, effects on real-world experience of interest/pleasure and clinical symptoms of anhedonia will be evaluated in a second, larger clinical trial (R33). F-PPE was designed to increase child positive valence systems function through mother-child training in behavioral and cognitive skills to increase pleasant activities and attention towards/savoring the positive, individual and dyadic goals, and skills practice. For the R61 phase, eligible child participants (N=60 intervention completers) will complete an EEG assessment of neural reward responsiveness, as well as halfway through the intervention (4 weeks) to determine dose effects. Children and their biological mothers will be randomly assigned to 8 sessions of F-PPE or a psychoeducation comparison condition (groups will be matched on child sex and baseline RewP). Both interventions will be administered through individual telehealth sessions with a masters- or doctoral-level clinician under the supervision of the PIs. To ensure treatment fidelity, videotaped sessions will be reviewed for adherence to the protocol, clinicians will participate in weekly group supervision, and supervisors will randomly review recorded sessions for ratings of treatment adherence.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Reward Responsiveness as a Prevention Target in Youth At Risk for Anhedonia
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Jun 30, 2025
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Family Promoting Positive Emotions

Behavioral: Family Promoting Positive Emotions
An 8-week dyadic intervention using cognitive and behavioral skills to up-regulate positive emotions in children and mothers

Active Comparator: Psychoeducation

Behavioral: Psychoeducation
An 8-week comparison condition that offers education in mental health, depression prevention, and accessing mental health resources

Outcome Measures

Primary Outcome Measures

  1. Neural responses to rewards measured by electroencephalogram (EEG) in a computerized guessing reward task (physiological measure) [4 and 8 weeks]

    The reward positivity (RewP) component will be measured using EEG with an established computerized guessing reward task ("Doors" task). EEG data will be processed using best practices and the RewP component will be exported from the EEG data approximately 250-350 ms after feedback presentation at the electrode Cz. RewP scores will be quantified as the relative neural response to reward vs. loss feedback.

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Biological mothers with past or current MDD with anhedonia and their 8- to 12-year-old children

  • English-speaking mothers and children

Exclusion Criteria:
  • Children with past or current major depressive disorder (MDD) and/or anhedonia lasting most of the day, nearly every day for at least 2 weeks based on semi-structured interviews will be excluded

  • A lifetime manic episode in mothers or children

  • Mothers with current substance use disorders

  • Mothers or children with intellectual or developmental disabilities

  • Mothers or children with vision or hearing impairments that interfere with participation

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Vanderbilt University
  • Nationwide Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Autumn Kujawa, Associate Professor, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT05988138
Other Study ID Numbers:
  • 230616
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 14, 2023