Prevention of Anhedonia in Children

Vanderbilt University

Status

Active, not recruiting

Conditions

Anhedonia

Depression

Treatments

Behavioral: Psychoeducation

Behavioral: Family Promoting Positive Emotions

Study type

Interventional

Funder types

Other

Identifiers

NCT05988138

230616

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

8 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Biological mothers with past or current MDD with anhedonia and their 8- to 12-year-old children
Child and biological mother can read and speak fluently in English
Child and mother have access to a computer or tablet and internet for videoconferencing
For compensation purposes, child and biological mothers must be U.S. citizens

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
Mothers or children with intellectual or developmental disabilities
Mothers with past 6 months substance use disorder with moderate or greater severity
Children or mothers with a lifetime history of a manic or hypomanic episode/bipolar disorder
Children or mothers with a psychotic disorder (e.g., schizophrenia)
Children or mothers with visual or hearing impairments that interfere with completing study measures and sessions
Child offspring of a mother who has previously participated in the study with another biological child
Children taking medications for emotional or behavioral problems other than SSRIs (stable dose for 6 weeks before time of enrollment) or psychostimulants