NCT03564847

Brief Summary

The aim of the study is to evaluate the clinical and cost effectiveness of culturally adapted group parenting intervention delivered by non-specialists and community health workers for depressed fathers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
357

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

1.5 years

First QC Date

May 23, 2018

Last Update Submit

October 9, 2020

Conditions

Depression

Keywords

Learning Through Play PlusCognitive Behavior TherapyParenting InterventionLow and middle-income country

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Scale HAM-D 17 (Hamilton, 1960)

    The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. The HAM-D is a simple 17 item self-report questionnaire can also be administered by a trained research worker. The translated version of the scale has been used in previous studies in Pakistan (Husain et al., 2017). It takes about 10 to 15 minutes to administer this scale. A score of 0-7 indicates normal, 8-13 mild depression, 14-18 moderate depression, 19-22 severe depression and \> 22 severe depression

    Changes from Baseline to 4th and 6th Month

Secondary Outcomes (21)

  • Generalized Anxiety Disorder (GAD) 7 (Spitzer, Kroenke, Williams, & Löwe, 2006):

    Changes from Baseline to 4th and 6th Month

  • Rosenberg's Self-Esteem Scale (Rosenberg, 1995)

    Changes from Baseline to 4th and 6th Month

  • Brief Disability Questionnaire BDQ:(Von Korff, Ustun, Ormel, Kaplan, & Simon, 1996)

    Changes from Baseline to 4th and 6th Month

  • Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2003)

    Changes from Baseline to 4th and 6th Month

  • Client Satisfaction Questionnaire (CSQ) (Attkisson & Greenfield, 1995)

    After completion of the intervention at 4th month only

  • +16 more secondary outcomes

Study Arms (2)

LTP Plus

EXPERIMENTAL

LTP Plus Participants will receive the intervention over 4 months Weekly sessions for 2 months and fortnightly for next two months by trained non-specialists/community health workers.

Behavioral: LTP Plus

Treatment As Usual (TAU)

NO INTERVENTION

Treatment as Usual (TAU) group will receive routine care and their follow up will be done at 4th and 6th month post randomization.

Interventions

LTP PlusBEHAVIORAL

LTP+Dads is a 12 - session group integrated parenting intervention: i.e LTP (Learning through Play) which includes a pictorial calendar, consisting of stages of child development from birth to 3 years. It includes parent-child play and other activities that promote parental involvement, learning, and attachment. In each stage, there are five areas of child development: sense of self, physical, relationships, understanding, and communication. All areas are written in simple, low-literacy language. Second component of intervention is CBT adapted from Jeanne Miranda manual (Group CBT for Depression, group leaders guide book-2006) focusing on the three areas: thoughts and your mood, activities and your mood, people interaction and your mood. Third component of intervention is content taken from Ed Bader's manual (Focus on Fathers) includes importance of fathers in child development, stress management at work and home, budgeting, anger management, conflict resolution and time management.

LTP Plus

Eligibility Criteria

Age18 Years - 55 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly Fathers will be included in the study
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to 55 years old fathers
  • Having children aged between 0-30 months
  • Diagnosis of major depressive disorder using the Structure Clinical Interview for DSM-V,
  • Ability to complete a baseline assessment.
  • Given written informed consent

You may not qualify if:

  • Any medical illness that will prevent them from participation in the clinical trial,
  • Current or past diagnosis of bipolar depression
  • Currently using antidepressants or receiving any kind of psychotherapy
  • Active suicidal ideation,
  • Any other severe physical or mental disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bin Qasim Town

Karachi, Sindh, Pakistan

Location

Orangi Town

Karachi, Sindh, Pakistan

Location

Related Publications (12)

  • Hasin DS, Goodwin RD, Stinson FS, Grant BF. Epidemiology of major depressive disorder: results from the National Epidemiologic Survey on Alcoholism and Related Conditions. Arch Gen Psychiatry. 2005 Oct;62(10):1097-106. doi: 10.1001/archpsyc.62.10.1097.

    PMID: 16203955BACKGROUND

  • Hirschfeld RM, Montgomery SA, Keller MB, Kasper S, Schatzberg AF, Moller HJ, Healy D, Baldwin D, Humble M, Versiani M, Montenegro R, Bourgeois M. Social functioning in depression: a review. J Clin Psychiatry. 2000 Apr;61(4):268-75. doi: 10.4088/jcp.v61n0405.

    PMID: 10830147BACKGROUND

  • Husain MI, Chaudhry IB, Husain N, Khoso AB, Rahman RR, Hamirani MM, Hodsoll J, Qurashi I, Deakin JF, Young AH. Minocycline as an adjunct for treatment-resistant depressive symptoms: A pilot randomised placebo-controlled trial. J Psychopharmacol. 2017 Sep;31(9):1166-1175. doi: 10.1177/0269881117724352. Epub 2017 Aug 31.

    PMID: 28857658BACKGROUND

  • Husain N, Chaudhry I, Raza-ur-Rehman, Ahmed GR. Self-esteem and obsessive compulsive disorder. J Pak Med Assoc. 2014 Jan;64(1):64-8.

    PMID: 24605716BACKGROUND

  • Husain N, Chaudhry N, Jafri F, Tomenson B, Surhand I, Mirza I, Chaudhry IB. Prevalence and risk factors for psychological distress and functional disability in urban Pakistan. WHO South East Asia J Public Health. 2014 Apr-Jun;3(2):144-153. doi: 10.4103/2224-3151.206730.

    PMID: 28607300BACKGROUND

  • Husain N, Parveen A, Husain M, Saeed Q, Jafri F, Rahman R, Tomenson B, Chaudhry IB. Prevalence and psychosocial correlates of perinatal depression: a cohort study from urban Pakistan. Arch Womens Ment Health. 2011 Oct;14(5):395-403. doi: 10.1007/s00737-011-0233-3. Epub 2011 Sep 4.

    PMID: 21898171BACKGROUND

  • Kane P, Garber J. The relations among depression in fathers, children's psychopathology, and father-child conflict: a meta-analysis. Clin Psychol Rev. 2004 Jul;24(3):339-60. doi: 10.1016/j.cpr.2004.03.004.

    PMID: 15245835BACKGROUND

  • Kaufman J, Yang BZ, Douglas-Palumberi H, Houshyar S, Lipschitz D, Krystal JH, Gelernter J. Social supports and serotonin transporter gene moderate depression in maltreated children. Proc Natl Acad Sci U S A. 2004 Dec 7;101(49):17316-21. doi: 10.1073/pnas.0404376101. Epub 2004 Nov 24.

    PMID: 15563601BACKGROUND

  • Klein DN, Lewinsohn PM, Rohde P, Seeley JR, Olino TM. Psychopathology in the adolescent and young adult offspring of a community sample of mothers and fathers with major depression. Psychol Med. 2005 Mar;35(3):353-65. doi: 10.1017/s0033291704003587.

    PMID: 15841871BACKGROUND

  • Naeem F, Gul M, Irfan M, Munshi T, Asif A, Rashid S, Khan MN, Ghani S, Malik A, Aslam M, Farooq S, Husain N, Ayub M. Brief culturally adapted CBT (CaCBT) for depression: a randomized controlled trial from Pakistan. J Affect Disord. 2015 May 15;177:101-7. doi: 10.1016/j.jad.2015.02.012. Epub 2015 Feb 23.

    PMID: 25766269BACKGROUND

  • Ramchandani P, Stein A, Evans J, O'Connor TG; ALSPAC study team. Paternal depression in the postnatal period and child development: a prospective population study. Lancet. 2005 Jun 25-Jul 1;365(9478):2201-5. doi: 10.1016/S0140-6736(05)66778-5.

    PMID: 15978928BACKGROUND

  • Husain MI, Kiran T, Sattar R, Khoso AB, Wan MW, Singla DR, Umer M, Mangrio R, Bassett P, Chaudhry IB, Zafar SN, Jafri FA, Chaudhry N, Husain N. A Group Parenting Intervention for Male Postpartum Depression: A Cluster Randomized Clinical Trial. JAMA Psychiatry. 2025 Jan 1;82(1):22-30. doi: 10.1001/jamapsychiatry.2024.2752.

    PMID: 39356541DERIVED

MeSH Terms

Conditions

Depression

Interventions

Long-Term Potentiation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Neuronal PlasticityNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Nasim Chaudhary, MD

    PILL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Researchers doing outcome assessment will be kept blind to the group allocations
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2018

First Posted

June 21, 2018

Study Start

June 1, 2018

Primary Completion

November 30, 2019

Study Completion

November 30, 2019

Last Updated

October 14, 2020

Record last verified: 2020-10

Locations

PA(2)